Alexander Technique and Supervised Physiotherapy Exercises in back paiN (ASPEN) Feasibility Trial

Article history

The research reported in this issue of the journal was funded by the EME programme as project number 09/160/23. The contractual start date was in January 2011. The final report began editorial review in October 2013 and was accepted for publication in April 2014. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The EME editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Paul Little is editor-in-chief of the Programme Grants for Applied Research journal.

Copyright statement

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Little et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Existing research

The lifetime prevalence of back pain has been estimated at between 59% and 90% and the annual incidence of back pain is approximately 5% of the population. 1 In the UK, 12.5% of all sick days are related to low back disorders (matched only by respiratory illness and mental illness), with very similar figures for other northern European countries. 2 Persistent or major recurrent back pain is one of the commonest chronic problems managed in primary care and has a poor long term prognosis. 3

Physiotherapy exercises

The literature supports the use of a course of supervised physiotherapy exercises tailored to patient expectations and with reinforcement in the management of chronic back pain. 4–6 Systematic reviews support strengthening, stretching and aerobic exercises; exercises tailored to the individual that can also be performed at home; 20 hours of contact time (10 group sessions); and exercise targeting the rehabilitation of deep abdominal and lumbar paraspinal muscles. 4,6,7 The National Institute for Health and Care Excellence (NICE) has reviewed the literature since the above systematic reviews and, although supervised and tailored exercises were supported by NICE as one option for patients,8 the advice was tempered by the results from the major UK back pain exercise and manipulation (BEAM) trial,9 which found modest effects of exercise alone or with manipulation. However, attendance at exercise sessions in the UK BEAM trial was poor and exercises in this trial did not target the rehabilitation of deep abdominal and lumbar paraspinal muscles, which are known to require specific rehabilitation,10,11 suggesting that further trials could helpfully address both of these issues.

Alexander technique

The NICE systematic review8 included the Medical Research Council (MRC) Alexander Technique Exercise and Massage (ATEAM) trial12 in the section on exercises, but the Alexander technique is not a form of physiotherapy exercise. It involves learning what not to do as a first priority, that is, learning to become aware of, release and avoid harmful habits of muscle use and improve co-ordination of movement, which sets it apart from specific exercises. 12 It can be used during simple activities of daily living, such as walking, sitting, standing and bending – all activities adversely affected by back pain. The technique aims to teach the correct use of the postural mechanisms that regulate upright support and locomotion. These mechanisms involve co-ordination of the trunk, head and limbs, and motor control of postural muscles, which can be poorly operating in individuals with chronic back pain. 13–16 Mostly habitual and unnoticed, an individual can be taught to become more aware of these mechanisms and make different choices about movement, co-ordination and locomotion. 14,15 In particular, the Alexander technique addresses the co-ordination of the trunk and head as a core relationship for good movement. It is taught by specialist gentle touch and verbal instruction and an individual learns self-help through the combination of these methods.

Although there is limited evidence on the mechanism of action, there is preliminary evidence of effectiveness: a small trial documented short-term benefit17 and more robust empirical proof of concept has come from a larger trial (the MRC ATEAM trial12) which documented that the Alexander technique is likely to be effective after 1 year for chronic and recurrent back pain. Massage was included as a comparison group in the ATEAM trial as it provided similar touch and attention to the Alexander technique, but did not provide similar training in self-management skills. There was a shorter-term effect of massage (at 3 months) but no longer-term effect; in contrast, the effect of the Alexander technique, which is designed to provide lifelong self-management skills, persisted for a year. This suggests that the effectiveness of the Alexander technique is unlikely to be due to the non-specific effects of touch and attention.

There is good reason to believe that the Alexander technique is distinct in principles, aims and practice from physiotherapy. Physiotherapy aims to strengthen, stretch, increase aerobic capacity and improve motor control and uses specific supervised exercises that are then practised at particular times. In contrast, the Alexander technique involves teaching the awareness of and release of harmful muscle tension; involves proprioceptive re-education; concentrates primarily on the key relationship of head–neck–back; uses the semi-supine position as a core technique; involves guiding and assessing movement and co-ordination; and is practised during activities of daily living. 12

Key issues in the evidence base that required clarification are:

1. Efficacy: the efficacy of an intermediate course of lessons in the Alexander technique. The relationship between number of lessons and outcome is not linear [half the benefit of 24 lessons (full course) was provided by a short course (six lessons)12]. The ATEAM trial12 demonstrated that receiving six lessons was highly cost-effective. However, although many patients having six lessons did achieve a clinically meaningful benefit, the average benefit was at the lower end of clinically meaningful efficacy [an average increment of 1.4 on the Roland–Morris Disability Questionnaire (RMDQ) after 1 year compared with normal care]. Thus, more information is needed for the lower/middle part of the response curve. The proposed full trial in the present study will provide key information in the range that is most likely to provide the most meaningful efficacy for patients (i.e. lessons required to achieve a RMDQ increment of ≥ 2.0–2.5). 12,18

2. Efficacy: the efficacy of adding physiotherapy group exercises. If exercises and the Alexander technique work by different mechanisms then it is plausible that they will have significant additive effects that might provide substantial improvement for chronic back pain. The only way to demonstrate this is to estimate the single and combined effects of the two interventions.

Mechanism and biomechanical/physiological markers of improvement

Risks and benefits

No adverse effects have been reported for the Alexander technique12 and adverse effects of physiotherapy exercises are also rare. 8 It is likely that the proposed full trial could provide evidence of benefit not only for individual interventions but also for the combined intervention, which will provide a range of useful information to inform choice for patients, clinicians and policy-makers.

Rationale for the full trial

There are two key efficacy questions that the study will answer, one related to phase 2-type evidence (whether or not an intermediate ‘dose’ of a 10-lesson course in the Alexander technique achieves important clinical benefit) and one related to additive benefit (whether or not exercises are additive to the Alexander technique). We also propose enhancing our understanding by investigating the likely mechanisms using several plausible intermediate biomechanical markers that could mediate improved health outcomes. This should increase our understanding of the causes and treatment of back pain and could also be used in monitoring and targeting of future treatment. However, before a full study can be justified a smaller feasibility study is necessary.

Research design

This was a trial of two interventions, Alexander technique lessons and physiotherapy exercises. Clinical outcome and biomechanical/physiological measures were taken for all patients in this feasibility study (whereas if the main trial were to be funded the mechanistic measures will be taken on a subset of patients).

The study statistician supervised randomisation, blocked by group and stratified by history of previous pain (< 90 days and > 90 days). The board suggested stratification by previous history, which we accept is a very reasonable suggestion and which is supported by empirical evidence from a post hoc analysis of the ATEAM trial12 (those with a history of > 90 days of pain had the most improvement; furthermore, there was no evidence that making the criteria more stringent, for example > 180 days, increased apparent effectiveness).

When an eligible patient passed eligibility screening and consented to the study, randomisation was executed by the practice nurse in each practice ringing an external randomisation line.

Feasibility of recruitment

Several methods of recruitment were piloted and all proved to be feasible.

Feasibility of randomisation

There were no issues here except that there was some dropout of participants (n = 14) between consent and randomisation, as shown in the CONsolidated Standards Of Reporting Trials (CONSORT) diagram (Figure 1), mainly because of time pressures.

FIGURE 1.

CONsolidated Standards Of Reporting Trials (CONSORT) diagram. AT, Alexander technique; DNA, did not attend; EC, exercise classes.

Even with the relatively small numbers, the groups were reasonably well balanced at baseline (Table 4).

Feasibility of intervention lessons

Feasibility of retention

We followed up 57 of the 69 participants (83%) at 3 months and 56 out of 69 (81%) at 6 months. Those withdrawing mostly had other medical problems or problems with attending (Table 6). There was no significant difference in RMDQ score at baseline between those who withdrew and those who did not (10.25 vs. 10.28; p = 0.9836).

Feasibility of laboratory-based biomechanical and neuromuscular physiological measures

The board was concerned about the participant burden of the biomechanical measures. The feedback from patients was that this was one of the most interesting elements of the study, and follow-up rates for the measures were good despite the issues of time and transport. Pilot testing of all measures included in the research proposal revealed that measures of spine length and curvature using the Vicon 3D motion analysis system were complex and too time-consuming to warrant inclusion, as they were not key measures. Accurate alternative tools were not available.

All tests were well tolerated during the study, although a small number of participants (n = 14) reported mild sensations when standing in the trunk rotation testing device, including feeling nauseous, dizzy and unstable, but this did not prevent them being able to undergo testing. Surface EMG was used, which did not cause the discomfort that can occur with fine-wire EMG, but the drawback was poor-quality signals over the abdominal muscles, possibly because of subcutaneous fat. Data from the symptomatic side and during functional tasks (leg lifts for muscle thickness and EMG and changes in posture for Myoton measures) were more informative than data from the asymptomatic side and at rest. The duration of data collection sessions reduced as the study progressed (start approximately 120 minutes, end approximately 90–100 minutes) and proved to be acceptable to participants.

Sensitivity to change

Exploratory analyses of effectiveness

Exploratory analyses of intermediate markers (laboratory-based tests)

As with the clinical outcomes the analysis of intermediate measures is underpowered and so it is not very useful to comment on negative findings. Similarly, although we will briefly comment here on results significant at the 10% and 5% levels, extreme caution in the interpretation is needed given the danger of type 1 errors because of the number of intermediate markers present. The results should be viewed conservatively in the context of the hypothesised changes (Table 15) and the CHAIN model (see Figure 2 and Tables 19 and 20). The danger of type 1 errors is reduced by the fact that most biomarker and clinical changes, even if not significant, changed in a beneficial direction.

TABLE 15 - Hypothesised effects of the interventions on biomechanical and neuromuscular function: influences of Alexander technique lessons and physiotherapy exercise classes at 3 and 6 months post intervention

AT, Alexander technique; EC, exercise classes; N/A, not applicable (too few data for analysis).

Function	Hypothesised expected findings		Actual findings
	AT lessons	ECs	3 months	6 months
Proprioception – lumbar	Improve?	Improve	Yes – AT, AT + EC
Trunk muscle strength (Biodex)		Increase	Yes – EC extension
Paraspinal muscle size and contractility (ultrasound)		Increase		Yes – EC
Paraspinal muscle recruitment (EMG)	Improve?	Increase		Yes – AT
Abdominal muscle size and contractility (ultrasound)		Increase
Abdominal muscle recruitment (EMG)	Improve?	Improve motor control
Pelvic loading ability (ASLR)		Improve		Yes – AT
Trunk flexibility/axial tone	Improve			N/A
Muscle tone and mechanical properties	Improve (tone)	Improve (stiffness and tone)	Partially – AT, EC	Partially – AT, AT + EC

Differences between randomised groups at 3 months

Significant differences between randomised groups at 3 months were observed for lumbar proprioception and trunk extension strength (see Appendix 2, Table 16, for baseline measures and Appendix 2, Table 17, for 3-month measures).

For lumbar proprioception at 20° flexion, the Alexander technique and the Alexander technique plus exercise class groups had significantly lower errors (between the target position and the achieved position) than the control group (p = 0.026 and p = 0.035 respectively) after controlling for their baseline scores. The change in level of error for the exercise class group was in the same direction as for the other two groups and was significant at the 10% level (p = 0.08).

Trunk extension strength (measured using the Biodex system) in the exercise class-only group was significantly stronger (by 36 N/m; p = 0.027) than in the control group at 3 months. The changes in the other two groups were in the same direction.

The ASLR compression test was the only binary measure and so the odds of scoring a 1 on this test were compared by group. At 3 months the odds ratio was 1.03 (95% CI 0.18 to 5.82; p = 0.973) in the exercise class-only group, 2.10 (95% CI 0.24 to 17.78; p = 0.496) in the Alexander technique-only group and 0.59 (95% CI 0.10 to 3.40; p = 0.554) in the combined Alexander technique plus exercise class group.

Differences between randomised groups at 6 months (see Appendix 2, Table 18)

There were no longer any significant differences between randomised groups at 6 months for lumbar proprioception or trunk extension strength. There were additional differences that had not been seen at 3 months for multifidus muscle thickness at rest and contracted, the Myoton measurements of multifidus muscle mechanical properties, EMG onset of the lumbar paraspinal muscles and the ASLR test. The axial rotation testing device failed to function for a period (a replacement part had to be obtained from abroad) and so too few participants completed this test to enable reliable results to be obtained (n = 16 at 6 months, n = 9 at 3 months). The EMG recordings over the abdominal muscles were also too few to analyse because of difficulties in obtaining acceptable recordings.

Lumbar multifidus muscle thickness measured using USI was significantly greater in the exercise class-only group than in the control group in the relaxed and contracted muscle. These two variables were also significantly greater at the 10% level for the combined Alexander technique plus exercise class group. These observations were as expected for the exercise intervention, which included activities to improve the strength (and thus size) of the multifidus muscle as well as automatic activity of the muscle during functional tasks.

Multifidus muscle tone and mechanical properties were measured using the MyotonPRO device. There was lower elasticity (higher decrement values) in the treatment groups than in the control group, which reached significance below the 5% level only in the Alexander technique plus exercise class group in the prone lying position. The treatment groups had lower values than the control group for tone (frequency) and stiffness (N/m) and the difference reached significance at the 10% level for frequency in the prone position (p = 0.076). The mechanical properties of muscles measured by the MyotonPRO device differ according to the physiological composition and habitual activity of the muscle. 41 Few muscles have been characterised at this relatively early stage in the use of Myoton technology to allow definitive interpretation of these findings for the multifidus muscle. A fully powered study would help elucidate the relationships between Myoton parameters and other measures of muscle characteristics and behaviours. It is known, however, that Myoton technology can detect subtle changes in muscle stiffness42 and that the changes in parameters during muscle contraction include increases in stiffness and tone (frequency) and reduction in elasticity (increase in decrement). The present observations suggest that the combined Alexander technique plus exercise class group had less muscle tension than the control group.

Compared with the control group, earlier onset of EMG activity of paraspinal muscles occurred on the symptomatic side during an ipsilateral leg lift in the Alexander technique-only group for the multifidus muscle, indicating better motor control.

During the ASLR compression test, all three intervention groups showed an odds ratio of < 1 and this was highly statistically significant in the Alexander technique group (p = 0.007), indicating a better ability to transfer load through the pelvis.

Graphical CHAIN model

The graphical CHAIN model (Figure 2 and see Appendix 2, Table 19) demonstrates that the only significant predictor at baseline of RMDQ score at 6 months was number of days in pain. Three laboratory measurement variables at 6 months were associated with RMDQ score at 6 months. These were lumbar proprioception at 20° flexion (beta coefficient 1.48°, 95% CI 0.83° to 2.12°; p < 0.001) and the lumbar multifidus mechanical properties measured using the MyotonPRO of tone (frequency) (0.94 Hz, 95% CI 0.48 Hz to 1.40 Hz; p < 0.0001) and difference in elasticity (log decrement) from lying to sitting, that is, altered activity with change in posture (−4.86, 95% CI −0.01 to −9.72; p < 0.05). Even with the small number of participants, the Alexander technique was shown to influence the mechanical property of elasticity at 6 months, suggesting that this may be a key element of the effectiveness of the Alexander technique. Likewise, exercise classes were shown to influence change in muscle tone from lying to sitting, suggesting that improvement in postural tone is a key element in the effectiveness of physiotherapy.

FIGURE 2.

Graphical CHAIN model illustrating biomechanical and physiological variables associated with outcome 6 months after the intervention. AT, Alexander technique; TrA, transversus abdominus; US, ultrasound.

The baseline variables that were predictive of 6-month variables were laboratory measures, mainly proprioception, and multifidus muscle mechanical properties (using the MyotonPRO) and thickness (from USI). Of these baseline variables, multifidus muscle elasticity (difference in decrement values from prone to sitting measured using the MyotonPRO device) predicted four variables at 6 months: itself, proprioception in upright and flexion postures and multifidus muscle tone (change in Myoton frequency with posture). Multifidus thickness (when contracted during a straight leg lift, measured using USI) predicted itself, the thickness of the transversus abdominus muscle when contracted (which was reciprocally predictive of the thickness of the multifidus muscle when contracted) and proprioception in flexion. Five baseline variables were predictive of two variables each at 6 months. Going from left to right in the top row of Figure 2, the upright proprioception test predicted the Myoton measures of postural changes in tone (frequency) and stiffness. Contracted transversus abdominis muscle thickness predicted itself and contracted multifidus muscle thickness. Change in multifidus tone (frequency) with posture predicted itself and recruitment of the multifidus muscle (EMG onset). Multifidus tone at rest predicted itself and proprioception in flexion.

At 6 months, multifidus tone difference (i.e. change in frequency between lying and sitting) was associated with itself at baseline, body mass index, lumbar proprioception in the upright and 20° flexion positions, difference in multifidus tone (frequency) from prone to sitting and the exercise class-only intervention. The only other variable with more than two associations was proprioception in flexion, which was associated with multifidus thickness (contracted), multifidus tone at rest (Myoton frequency) and multifidus elasticity with change in posture (difference in decrement).

Understanding key issues in the trial: qualitative substudy

The qualitative substudy is reported in Appendix 3. This substudy documented the need for the provision of more information about the Alexander technique prior to consent (given its limited penetration in care to date), the low expectations of care for chronic back pain in the NHS and the low expectations of tailored physiotherapy classes (participants perceived that they were getting something that they had already tried and were pleasantly surprised by the group sessions). Time commitments for the interventions were a problem for some patients, but mostly there were very positive comments about both Alexander technique lessons and exercise classes and surprisingly positive comments about the biomechanical measurements.

Feedback from Alexander technique teachers

Carolyn Nicholls asked for feedback from all of the teachers involved in the study and their comments are shown in detail in Appendix 4. Most teachers reported observing significant benefits from the Alexander technique but commented on difficulties that participants had in arranging appointments, especially those receiving both Alexander technique lessons and exercise classes. For those who were working and looking after a family, keeping the appointments was doable but challenging. Retired people fared better in this respect. Several teachers commented that participants who received both Alexander technique lessons and exercise classes found the exercise classes easier, and this had also been noted by the physiotherapists.

Strengths and limitations

This study is the first to assess a 10-week course of Alexander technique lessons, to provide some comparison with a tailored group physiotherapy exercise class regime, to explore both the possible benefits of combining Alexander technique lessons and physiotherapy exercises and also possible biomechanical markers of recovery. The study was able to assess a number of areas of feasibility successfully, but being a feasibility study it was not powered to assess clinical or biomechanical outcomes and so it is particularly difficult to interpret negative findings and all estimates are very imprecise.

Nevertheless, the effects observed are in the range seen previously for a much more intensive Alexander technique intervention, and some were significant at the 5% or 10% level, even with such small numbers of participants. The ability to demonstrate changes in both clinical outcomes and biomechanical markers will be affected by adherence, which was mostly good or very good, but the impact of the physiotherapy exercise classes has probably been underestimated given the difficulties faced by some participants in attending classes. The number of intermediate biomechanical markers makes type 1 errors very likely but the risk of this is lessened by reference to our previous hypotheses and by the highly significant changes seen in key biomarkers in the CHAIN model, which cannot sensibly be explained by chance as they would be highly significant even if a Bonferroni correction was used. Interpretation of the inter-relationships between these variables will be more secure in a fully powered trial. We have shown that collection of heath-related quality of life data is feasible. It is very likely that both interventions are highly cost-effective, as the clinical outcomes are similar to those seen with previous more intensive and cost-effective interventions but the resource input is less;46 however, at this stage no formal economic modelling has been undertaken.

Feasibility outcomes

Several methods of recruitment were piloted: opportunistic recruitment in surgery (i.e. patient seen by the GP or nurse for an acute problem and then referred to the study), invited recruitment based on attendance with back pain in the last 5 years (as used in the ATEAM trial12) and invited recruitment based on very recent attendance with back pain. All of these methods proved to be feasible. The reason for exploring different methods was concern at the application stage that using invited recruitment for patients attending within the last 5 years (as in the ATEAM trial12) would target patients who might not be receiving current care in the NHS (and who would therefore be a non-attending population who were unlikely to use NHS resources); the board therefore requested that we also use opportunistic recruitment. Opportunistic recruitment in surgeries certainly provided some participants but the rate of recruitment was very slow and, if this method was used as the only method of recruitment, it would make the study much more expensive. As a result, we also piloted invited recruitment of patients who had been seen in the past week; this worked well and could provide an important mechanism for identifying eligible patients currently receiving care. Qualitative work documented that some patients who were not currently receiving care were not avoiding care but were not attending because they felt that, as a result of their past experiences of the NHS, the NHS had little to offer. Arguably, such patients should not be excluded from access to the interventions based on such past experiences.

The board had other major concerns. The first was about whether or not multiple intervention groups would be acceptable, given the number of sessions required to attend. This was certainly a problem for some patients, although even in the most intensive group most patients achieved good adherence for exercise classes (and better than in a previous large UK trial9) and, although patients clearly found it challenging based on both Alexander technique teachers’ comments and the qualitative study, adherence was excellent for Alexander technique lessons. However, the study highlights the need for a clearer explanation to be given about time commitments at the point of consent. One of the issues for patients was the time taken to travel to exercise classes and the fact that classes were at fixed times, which interfered with work and other commitments; there were similar issues for some patients with regard to Alexander technique lessons. Qualitative work suggested that for some patients the group environment was helpful and so abandoning the classes as a format for physiotherapy intervention would be premature.

A second concern was whether or not the RMDQ score was likely to be stable in the control group in the context of recent national guidance and, if not stable, whether or not this reflected higher referrals than previously. As we demonstrated the stability of the control group (a decrease in RMDQ score of only 1 point in 6 months) we did not investigate this further at this stage, although clearly in any future trial we would be able to document all referrals fully, as we did in the ATEAM trial12 by follow-up notes review.

Feasibility of laboratory biomechanical tests

All tests proved feasible although we had limited data from the axial tone testing device as it broke down and required a new part. To our surprise, many patients commented on how interesting the various tests were. There is currently no reason based on patient informal reports or the quantitative or qualitative data to significantly modify the measurement regimes, with the exception of EMG of the abdominal muscles, for which poor-quality signals were obtained; we would therefore not envisage using this measure in a larger trial.

Clinical outcomes

As expected, most outcomes did not reach significance at the 5% level, although some reached significance at the 10% level by 3 and 6 months, particularly in the combined group, and nearly all outcomes changed in a beneficial direction compared with the control group, which suggests that type 1 errors are not likely. Even with such small group numbers it seems likely that clinically important improvements were probably occurring [e.g. the RMDQ documented clinically important changes (> 2.5) by 6 months]. There was no clear evidence that the treatment effects were bottoming out by the end of 10 Alexander technique lessons or 12 exercise classes but, as the magnitude of the effects seems likely to be of the order of that seen with more intensive interventions, it will be difficult to justify more lessons or more classes in a future trial. Although in principle it might be possible to vary the numbers of lessons/sessions, to have more than four groups in any future trial (e.g. both 10 and 18 Alexander technique lessons and 12 and 18 exercise classes) would complicate and significantly increase the costs of the trial. There was good evidence of sensitivity to change of both the RMDQ and also the other main potential outcomes (Aberdeen pain and function scale, Oswestry Disability Index), and even the enlarged battery of questionnaires was acceptable to patients. Of the additional measures, the Aberdeen instrument seemed to differentiate between groups a little better than other outcomes and so would perhaps be the choice of additional instrument for any future main trial.

Effects of the interventions on laboratory measures at 3 months’ follow-up

The hypothesised relative effects of the Alexander technique and exercise classes on laboratory measures were summarised in the results section (see Table 15). The Alexander technique intervention was expected to improve trunk flexibility to imposed torsion (trunk rotation test); muscle tone (measured using the MyotonPRO device), proprioception of the cervical and lumbar areas; abdominal muscle recruitment (indicating improved motor control); and multifidus recruitment, muscle size and contractile ability. Of these measures, lumbar proprioception significantly improved comparison with the control group at 3 months.

The physiotherapy exercise class intervention was hypothesised to improve muscle stiffness and tone (measured using the MyotonPRO device); trunk muscle strength; pelvic loading ability (ASLR); proprioception of the lumbar spine; abdominal muscle recruitment; and multifidus muscle size and contractility. Of these measures, lumbar proprioception and trunk extension strength were improved compared with the control group.

Given the low power of the study, the significant findings at the 10% level for the different measures at 3 months may have reached significance at the 5% level with larger numbers of participants. It might be expected that the effects of the interventions may take 6 months to manifest for some of the biomechanical and neuromuscular function measures (see the following section).

Effects of the interventions on laboratory measures at 6 months’ follow-up

Alexander technique lessons resulted in improvements in multifidus muscle recruitment and mechanical properties (measured using the MyotonPRO device), which were predicted, as well as in pelvic loading ability, which had not been predicted. The expected effects on trunk flexibility and proprioception were not found, although there were very limited data to test the former (because of axial trunk rotation equipment failure).

The exercise class group showed expected improvements in multifidus muscle thickness, contractile ability and mechanical properties but not in muscle strength, recruitment or proprioception.

As already mentioned, it is likely that any negative results are due to the small group numbers (i.e. type 2 error) in this preliminary study and so they should be interpreted very cautiously; there could also be limitations because of the lack of sensitivity of the tests.

Mechanisms of treatment effects during recovery

The hypothesised effects of treatment were related to proposed mechanisms. The mechanism of action of the Alexander technique technique was proposed to be through improved muscle tone, proprioception (position sense) and motor control of spinal movements (indicated by earlier onset of EMG), and the importance of these was supported by the graphical CHAIN model. The physiotherapy exercise classes involved activities that would be expected to improve muscle strength, proprioception and motor control. These mechanisms were partially confirmed by this preliminary study, but confirmation and fuller exploration of the likely mechanisms requires a larger study.

Sensitivity and predictive value of assessment tools for later studies

The graphical CHAIN model at 6 months (see Figure 2 and Tables 19 and 20) indicates that the most predictive measures of the primary outcome at 6 months and other laboratory measures were proprioception, parameters of muscle mechanical properties (measured using the MyotonPRO device) and muscle thickness measurements (using USI). These were more predictive than EMG, which is a gold standard laboratory technique used in back pain research. 21,39

It is important to stress here that the relationship between clinical outcomes and biomechanical and neurophysiological markers commonly used in back pain research has yet to be clarified. It is widely reported that lower back pain is associated with abnormal muscle morphometry (thickness at rest and change during contraction) and motor control. Measurements of these two parameters (using USI and EMG) are often used to target interventions but baseline tests are not predictive of outcome47 and changes in muscle parameters pre–post intervention may not correlate with clinical outcomes, although limited evidence exists for change in multifidus thickness. 48 A possible explanation for this lack of correlation may be that the tests used are not relevant to the impairment being targeted. In previous studies on which these observations of abdominal and lumbar spine muscles were based, the tasks used to elicit involuntary contraction of trunk muscles were mainly arm lifts (some used voluntary abdominal muscle contraction, which is not as functional as automatic contraction). We therefore used leg lifts to see whether or not correlation with clinical measures could be improved, as leg lifts might be more functionally relevant to the lumbopelvic muscles than arm lifts. 49 The present preliminary findings showed that most of the laboratory techniques used were sensitive to change pre to post intervention at 6 months (see Table 8), although these measures were not well correlated with clinical outcomes (see Figure 2 and Table 19). We also used novel tests of muscle characteristics that would be relevant to altering muscle tone, which the Alexander technique aims to influence. These novel tests were (1) the trunk rotation test, which was recently found to be sensitive to a reduction in resistance to rotation immediately after an Alexander technique session in people with lower back pain,20 and (2) MyotonPRO technology for testing non-neural tone and mechanical properties of muscle, including stiffness and elasticity.

Another important point to highlight is that lack of correlation between the clinical measures and the laboratory measures does not necessarily mean that the muscle tests are insensitive to change; it could indicate that, although an intervention has been clinically beneficial in reducing symptoms and improving function, it may not have been effective at treating the muscle impairment. An example of this possibility was demonstrated by a study of targeted multifidus exercises compared with medical treatment in acute lower back pain, which found that muscle wasting did not recover without exercises but that symptoms resolved in both the treatment group and the control group. 22 Importantly, when patients were followed up at 1 and 3 years, there was a significantly greater recurrence of lower back pain in the control group. 50 The findings suggest that the dissociation between muscle measurements and clinical outcomes indicated that the spine was at risk of further injury.

The multifidus and abdominal muscle thickness measures were related (see Figure 2), as expected from the literature,47 but there is very limited evidence available on the predictive value of ultrasound muscle thickness measurements. 47,48,51

The Myoton and axial trunk rotation devices both provide indications of muscle tone (state of tension) and so might be expected to show similar findings. However, there were insufficient data from the trunk rotation device to enable their comparison at this stage. The Myoton observations are novel as research on the technology is in the relatively early stages. Myoton parameters relate to proprioception and muscle thickness measures. The axial rotation test is also relatively new, with limited existing literature on the test. 14–16,20

Muscle strength gives an indication of functional capacity and testing is commonly used in back pain studies but relies on volition. Maximal effort can be affected by pain or fear of pain and so the lack of effect of interventions on trunk muscle strength may have been influenced by the methodology. Furthermore, maximal effort was not confirmed by twitch interpolation electrical stimulation, for practical reasons. 52

Recommendations for a future trial

We propose that any future full trial should ideally:

• include all three participant recruitment strategies with the same inclusion criteria but aim to include at least half of those who have been identified as having care recently (i.e. opportunistic or invited based on attendance in the last week) to be able to explore possible differences in effectiveness.

• include the RMDQ as the primary outcome

• include secondary outcomes – the battery of secondary outcomes recommended for back pain research and included in this and the previous trial (days in pain, Von Korff pain and disability scale, Deyo troublesomeness scale, overall improvement, enablement, fear of activity), but also the Aberdeen instrument

• include biomechanical/neuromuscular physiological measures – include the same range of laboratory markers included in the feasibility study, except for EMG of abdominal muscles

• maintain 10 lessons of Alexander technique and 12 classes of physiotherapy, but explore ways of improving the flexibility and accessibility of the interventions when possible

• include a more extensive discussion of trial commitments at the time of consent.

Contributions of authors

Professor Paul Little had the original idea for the study, led the development of the protocol and the grant application, provided overall co-ordination and drafted the first version of the report.

Dr Beth Stuart developed the analysis protocol with Professor Peter Smith and performed the analysis of the quantitative measures and commented on drafts of the report.

Professor Maria Stokes helped develop the overall protocol and grant application, developed the biomechanical protocols, provided co-ordination of the biochemical measures, drafted the report of the biomechanical measures and commented on drafts of the report.

Mrs Carolyn Nicholls helped develop the overall protocol and grant application, developed the structure of the training, lessons and outcomes for Alexander technique teachers, co-ordinated the Alexander technique teachers and delivery of the Alexander technique lessons and commented on drafts of the report.

Dr Lisa Roberts helped develop the overall protocol and grant application, helped develop the biomechanical protocols, developed the physiotherapy exercise class intervention and co-ordinated the classes and commented on drafts of the report.

Dr Stephen Preece helped develop the overall protocol and grant application, developed the biomechanical protocols with Professor Maria Stokes and commented on drafts of the report.

Dr Tim Cacciatore helped develop the overall protocol and grant application, developed the biomechanical protocols with MS, advised on the purchase, construction and use of the torsion device and commented on drafts of the report.

Mr Simon Brown developed the protocol for the biomechanical measures with Professor Maria Stokes and performed the measures and analysed the output and contributed to drafting of the report.

Professor George Lewith developed the original idea of the study with Professor Paul Little, contributed to the development of the protocol and the grant application and commented on the draft report.

Dr Adam Geraghty helped develop the overall protocol and grant application, commented on drafts of the report and supervised the qualitative study.

Professor Lucy Yardley helped develop the overall protocol and grant application, commented on drafts of the report and with Dr Adam Geraghty supervised the qualitative study.

Mrs Gilly O’Reilly helped develop the overall protocol, co-ordinated the study on a day-to-day basis and commented on drafts of the report.

Mrs Caroline Chalk helped develop the overall protocol and grant application and developed the structure of training, lessons and outcomes for Alexander technique teachers.

Professor Debbie Sharp developed the original idea of the study with Professor Paul Little, contributed to the development of the protocol and the grant application and commented on the draft report.

Professor Peter Smith helped develop the overall protocol and grant application, developed the analysis protocol, co-ordinated the statistical analysis and commented on drafts of the report.

Disclaimers

This report presents independent research. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, NETSCC, the EME programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the EME programme or the Department of Health.

Appendix 1.1: Detailed description of the Alexander technique and lessons

The Alexander technique is a taught approach. Anyone taking Alexander technique lessons is regarded as learning the technique, not as a patient; lessons are not a form of passive therapy or treatment.

The teachers’ aim was to teach the Alexander technique and how to make use of it to reduce the intensity and frequency of poor habits and facilitate improvements in co-ordination, muscle tone and musculoskeletal use.

Teachers first investigated whether or not there was something – perhaps a particular habitual way of standing, sitting or moving – that was underlying or exacerbating the problem. Habits that restrict freedom of movement of the head and neck and that cause stiffening and shortening of the spine and commonly result in pain were given priority and were progressively reduced.

Appendix 1.2: Physiotherapy exercise class content

Session content

Warm-up and stretching (10 minutes)

This is important to prepare the body for the activities ahead. It included:

1. General warm-up: light physical activity that results in a light sweat. Examples include:

   • trampette

   • cycling using static pedals

   • exercise bike

   • treadmill

2. Stretches: major muscle groups including:

   • hamstrings

   • quadriceps

   • calf (gastrocnemius and soleus)

   • Iliopsoas

   • cervical spine extension

   • cervical spine side flexion

   • shoulder rolls

   • triceps

   • horizontal flexion

   • thoracic spine rotation

   • lumbar side flexion.

Possible circuit activities

Stretching and mobilising
1		One-legged knee curl Lie on your back Lift one knee at a time towards your chest Hold for 20 seconds Start with _____	Alternate knee to chest
2		Two-legged knee curl Lie on your back Lift both knees together towards your chest Hold for 20 seconds Start with _____	Supine knee curls
3		Prone back stretch Lie on your front, supported by your elbows Keep your tummy in contact with the ground Hold for 20 seconds Start with _____	Spinal extension
4		Kneeling back stretch Start on your hands and knees Keeping your hands still, sit back on your heels Feel the stretch between your shoulder blades Hold for 20 seconds Start with _____	Spinal flexion in kneeling or child pose with shoulder elevation
5		Log roll Lie on your back with one arm out to the side Roll like a log towards the arm, bringing your hands together Return to the centre and roll to the other side Start with _____	Log roll
6		Knee drops Lie on your back with your knees bent Roll your knees to one side Return to the centre and roll them to the other side Start with _____	Lumbar rotation
7		Supine back stretch Lie on your back. Bend your left knee, leaving your right leg on the floor Place the left leg over the right leg, keeping the shoulders in contact with the floor Start with _____ to each side	Lumbar rotation with knee extension
8		Pelvic tilting on hands and knees Start on your hands and knees Round and hollow the back slowly and then arch down Start with _____	Pelvic tilting in four-point kneeling
9		Pelvic tilting with towel Lie on your back with your knees bent Place a folded towel under your hips Gently tilt your pelvis up and down Start with _____	Crook lying pelvic tilt with towel
10		Standing rotation Holding a ball in front of you, take both hands to one side and then the other Keep your hips facing forwards This will help you gently rotate your back Start with _____	Thoracic rotation
11		Sitting side bend Sit on a gym ball Hold a hand weight in each hand Bend down to the right Return to the centre and repeat to the left Start with _____	Thoracic side flexion
12		Thigh stretch Lie on your back. Bend your left hip to 90° Grasp your thigh and gently try to straighten your knee Hold for _____ seconds Start with _____ stretches	Hamstring
13		Sitting leg swing Sit in a slouched position While looking down, straighten one leg Then look up to the ceiling while bending the leg Start with _____	Neurodynamic slider in slump sitting
Motor relearning, balance and co-ordination exercises
14		Gym ball – sitting Sit up straight and as still as you can on the ball Start with _____ seconds/minutes	Gym ball – sitting
15		Gym ball – arms Sit up straight and hold both arms out to the side Try and keep as still as you can on the ball Start with _____ seconds/minutes	Gym ball sitting with 90° shoulder abduction
16		Gym ball – sitting rock Sit up straight on the gym ball with your arms by your sides Then slouch Sit up straight again Keep repeating this rocking action Start with _____	Gym ball – pelvic tilting in sitting
17		Gym ball – foot lift Sit up straight on the ball with your hands by your sides Lift one foot off the ground while trying to keep as still as you can Hold for _____ seconds Start with _____	Gym ball – hip flexion
18		Kneeling without one arm Start with your back flat on your hands and knees Slowly raise one hand Keep your back still (no twisting the trunk or pelvis!) Hold for _____ seconds Start with _____	Four-point balance arm extension
19		Kneeling without one leg Start with your back flat on your hands and knees Slowly raise one leg Keep your back still (no twisting the trunk or pelvis!) Hold for _____ seconds Start with _____	Four-point balance leg extension
20		Kneeling without one arm or leg Start with your back flat on your hands and knees Slowly raise one leg and the opposite arm Keep your back still (no twisting the trunk or pelvis!) Hold for _____ seconds Start with _____	Four-point balance alternate arm and leg extension
Strengthening
21		Prone hold Lie on your front with your arms by your side Raise up your head and shoulders Hold for _____ seconds Start with _____	Isometric back extensors
22		Side lying leg lift Lie on your side with your top leg straight Lift your top leg towards the ceiling Start with _____	Hip abduction in side lying
23		Side lying bent leg lift Lie on your side with your top leg bent Lift your bent leg up towards the ceiling Start with _____	Hip abduction with knee flexion in side lying
24		Kneeling leg lift Start on your hands and knees Bend one leg up behind you to 90° Pump your leg up to the ceiling, keeping it bent Start with _____	Four-point kneeling hip extension with knee flexion
25		Wall squats Stand against a wall Slide down the wall to a squat, aiming for hips and knees at 90° Hold for _____ seconds Start with _____	90° squats against the wall
26		Chair squats Stand behind a chair Squat down, aiming for hips and knees at 90° Hold for _____ seconds Start with _____	90° squats with chair support
27		Ball squats Stand with a gym ball pressed against the wall Slide down the wall to a squat, aiming for hips and knees at 90° Hold for _____ seconds Start with _____	90° gym ball squats against the wall
28		Standing on one leg In standing, raise one leg so the thigh is horizontal Hold for _____ seconds Repeat with the other leg Start with _____	Alternate leg lifts
29		Toe raises While lightly holding the wall or a chair, rise up onto the balls of your feet Hold for _____ seconds Start with _____	Isometric calf
30		Bridging Lie on your back with both knees bent Tilt your pelvis backwards by pressing your lower back into the mat Slowly lift your hips off the floor Hold for _____ seconds before slowly lowering Start with _____	Bridging
31		Bridging on one leg Lie on your back with both knees bent Tilt your pelvis backwards by pressing your lower back into the mat Once your hips are off the floor, extend one leg Hold for _____ seconds. Return to the start and repeat with the other leg Start with _____	Bridging with leg extension
32		Wall press-up Stand facing the wall with your hands flat on the wall Do a press-up against the wall, using your arms to control the movement Start with _____	Wall press-up
33		Gym ball with weights Sit up straight on the ball Hold two hand weights out in front of you Try and keep as still as you can Start with _____	Gym ball – 90° flexion with hand weights
34		Lunges From a standing position, step forward with one foot Lunge, keeping your back as upright as possible Return to the standing position Repeat with the other leg Start with _____	Alternate forward lunges in standing
Activity modification
35		Touching your toes Start in standing Bend forwards so that your hands move towards your feet Try to keep as relaxed as possible Return to the standing position Start with _____	Flexion in standing
36		Sitting and standing Sit on a normal height chair with your arms across your chest Stand up, concentrating on bringing your nose forward over your toes Start with _____	Sit to stand
Cardiovascular
37		Exercise bike Level _____ Start with _____ minutes	Exercise bike
38		Treadmill Level _____ Incline _____ Start with _____ minutes	Treadmill
39		Step-ups Start with _____	Step-ups
40		Trampette Start with _____ minutes	Trampette
41		Cross-trainer Level _____ Start with _____ minutes	Cross-trainer

Cool down

Light, physical activity that results in a light sweat. Examples included:

• trampette

• cycling using static pedals

• exercise bike

• treadmill.

Stretches

As per the warm-up. Major muscle groups include:

• hamstrings

• quadriceps

• calf (gastrocnemius and soleus)

• iliopsoas

• cervical spine extension

• cervical spine side flexion

• shoulder rolls

• triceps

• horizontal flexion

• thoracic spine rotation

• lumbar side flexion.

Dr Lisa Roberts, December 2011

Aim

The aim of this study was to assess patients’ expectations, experiences and views of the treatment groups available as part of the Alexander technique and Supervised Physiotherapy Exercises in back paiN (ASPEN) trial.

Methods

Participants who were already part of the ASPEN trial were recruited to the study by written consent. The sample was a convenience sample of participants in the trial. Participants who responded were contacted by telephone to arrange a suitable time for their interview. Data collection was performed using semistructured qualitative interviews.

Interview process

Interviews were conducted by telephone at a time that was convenient to the participant. The interviews followed an interview schedule that is shown later in this appendix (see Interview schedule). The interviews explored participants’ expectations and views of treatment options at the start of the trial and looked at how these views had changed during its course. Another important part of the interviews discussed measurements of the participants that were taken as part of the ASPEN trial. This aimed to explore whether or not these measurements made sense to the participants and to assess if they caused any problems.

Questions were designed to be open to gain the most in-depth understanding of the research questions. Each of the interviews lasted 20–35 minutes and was audio taped; the recordings were then sent for transcription.

Analysis

A thematic analysis was performed, as described by Braun and Clarke,56 starting with familiarisation with the data. A coding manual was created, enabling each code to be defined. As the analysis continued the coding manual was constantly reviewed and altered as new codes emerged. As this was a joint project, with two of the researchers being relatively inexperienced, the initial transcripts were coded together to ensure that both researchers could become clear on the coding process. Transcripts were then analysed separately by the researchers and, as the coding process developed, we met to evaluate, discuss and refine our coding manual. The coding process and manual were reviewed by Dr Adam Geraghty and Professor Paul Little.

Results

In total, 59 consent forms were posted to participants in the ASPEN trial; 28 consent forms were returned and 20 participants were available to contact for an interview. One further participant was excluded because of an upcoming medical procedure and therefore 19 interviews were performed. In total, 13 of the patients were female and six were male. The youngest participant was aged 20 years and the oldest (and modal) age was 66 years. The average age of participants in the data set was 53.8 years. All of the participants described their ethnicity as white. Of the participants interviewed, six came from the physiotherapy exercises group, five from the Alexander technique group, five from the combined therapy group and three from the normal care group; perhaps the most instructive group were the combined group, and the themes that came from this group were largely replicated in the other groups.

The themes and subthemes that were identified are shown in Table 21.

Interview schedule

Teacher 1

I had one pupil, who managed both Alexander technique and physiotherapy exercise, she found Alexander technique useful to a degree within her habitual limitation whilst exercising. The pupil was attentive during her lesson and found it helped her mobility when applying the technique to her use.

I was allocated three pupils all of whom came from an area that took two buses and a ten minute uphill walk to reach me, the one pupil that actually managed to complete the course, after a few lessons was provided with a taxi to and from the lesson (I had spoken to the office regarding the surgery location initially), but somehow they were convinced it was the nearest one to myself.

The other two pupils with whom I made contact, made lesson appointments but did not turn up, having varying excuses from, they’d forgotten, to having to collect their benefit or not answering the phone at all. Unfortunately the surgery covered an area of benefits and unemployment that did not lend itself to commitment.

Teacher 2

I had four people and all of them finished the trial and were very appreciative of the Alexander technique lessons. In all four cases their back pain reduced significantly, I think actually it went completely in every case. One, who had a number of other problems, has carried on having lessons with me and another sent his wife who brought her daughter and her friend for lessons. Two of the four were also supposed to have physiotherapy sessions and one completed them together with her Alexander technique lessons satisfactorily. The other opted out of the physiotherapy because he couldn’t get enough time off from work to attend the sessions.

Teacher 3

It was generally easier for the older people to engage with the project and adhere to their commitments. Working people, particularly with children, found the amount of hours of the commitment difficult. The times for physiotherapy (morning or afternoon) was difficult for working people. Nobody dropped out.

Teacher 4

The two with Alexander technique and physio were both retired and were able to fit both types of disciplines in without a problem. They both showed positive signs of freedom of movement with all the aspects of the Alexander technique that I taught them, with a noticeable difference in being able to bend down to put on their shoes and generally to be able to walk about without as much pain as they had previous to their Alexander technique lessons.

Both enjoyed their physio exercises and found that once they had had one or two physio sessions and then came back to the Alexander technique after, they could see the benefit that having six Alexander technique lessons first before starting physio made a difference. They both reported that it would have been quite difficult to carry out some of the exercises as easily without the knowledge of the Alexander technique. One pupil remarked that the physiotherapist was quite amazed in their ability and suppleness and ease to be able to sit and stand as well as they did and was interested to know (and HOW) what the Alexander technique lessons entailed and what the Alexander technique was doing for them. The third person (male) regrettably dropped out at lesson 9 due to work commitments and sent to work in Scotland. All three pupils had a significant drop in pain over their course of lessons from most days with pain to only occasional pain, but they reported that the level of pain became less especially with the Semi Supine which they practised each day.

Teacher 5

I had one person pull out, in fact she never started, she said she was doing ‘lots‘ to help her back and didn’t want anything else. She sounded very worried on the phone, as if I was going to try and force her. Case 1 was completely changed by the sessions realising her attitude wasn’t helping her back pain, as well as making some postural change, her back pain was considerably reduced. Case 2 I could see the Alexander technique was helping her and she admitted the sessions had helped her in how she went about her day.

Teacher 6

Generally the lessons were very well received. I had one drop out after two lessons. Her reason was that the two lessons had totally cured her back pain! She was also struggling to juggle work/family commitments so did not want to put more time in when she felt she had what she needed. The only pupil that I feel did not respond had diagnosed Parkinson’s disease (and I don’t think that he should have been accepted on to the trial). One lady had back pain particularly first thing in the morning. She apparently had an old bed so I do wonder just how much this held back her progress.

Teacher 7

I had one pupil who declined the physio sessions because she had four children and it meant she would not be able to pick up from school but she did complete the Alexander technique lessons with much reduced pain by the end. I had one pupil who had both the Alexander technique and physio, she was most impressed with the obvious very apparent difference, between herself and others who had had Alexander technique lessons. All the pupils I had seemed impressed with how they felt when they remembered to direct and the reduction in pain and discomfort, however none signed up for private lessons. Could this be because at the end of 10 lessons they felt they could manage? It would be interesting to know how they feel a year on.

One pupil who had a heart op after nine lessons did not return to take up the 10th but wrote a letter to say how helpful the Alexander technique directions had been in the recovery process but was unable to make the journey out to me.

Teacher 8

Two of my pupils from the trial did physio plus the Alexander technique and found the both most helpful. They both mentioned how well the physios worked with the technique, and lying down after the exercises. One in particular continued lessons for quite a while after the study but has since drifted off. He did manage to reduce the amount of painkillers he took, of which he was taking a great deal. The second one thought she had learned enough with the Alexander technique and the physio exercises to manage on her own. Her physio continued after her lessons ended, so I don’t know how she ended the trial.