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1.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain 
Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.
Design Factorial randomised trial.
Setting 64 general practices in England.
Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.
Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.
Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain.
Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported.
Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.
Trial registration National Research Register N0028108728.
doi:10.1136/bmj.a884
PMCID: PMC3272681  PMID: 18713809
2.  Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial 
Trials  2013;14:209.
Background
Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study.
Methods/Design
We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.
The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.
Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.
The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes.
Discussion
This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety.
Trial registration
Current Controlled Trials ISRCTN15186354
doi:10.1186/1745-6215-14-209
PMCID: PMC3720220  PMID: 23841901
3.  United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care 
BMJ : British Medical Journal  2004;329(7479):1381.
Objective To assess the cost effectiveness of adding spinal manipulation, exercise classes, or manipulation followed by exercise (“combined treatment”) to “best care” in general practice for patients consulting with low back pain.
Design Stochastic cost utility analysis alongside pragmatic randomised trial with factorial design.
Setting 181 general practices and 63 community settings for physical treatments around 14 centres across the United Kingdom.
Participants 1287 (96%) of 1334 trial participants.
Main outcome measures Healthcare costs, quality adjusted life years (QALYs), and cost per QALY over 12 months.
Results Over one year, mean treatment costs relative to “best care” were £195 ($360; €279; 95% credibility interval £85 to £308) for manipulation, £140 (£3 to £278) for exercise, and £125 (£21 to £228) for combined treatment. All three active treatments increased participants' average QALYs compared with best care alone. Each extra QALY that combined treatment yielded relative to best care cost £3800; in economic terms it had an “incremental cost effectiveness ratio” of £3800. Manipulation alone had a ratio of £8700 relative to combined treatment. If the NHS was prepared to pay at least £10 000 for each extra QALY (lower than previous recommendations in the United Kingdom), manipulation alone would probably be the best strategy. If manipulation was not available, exercise would have an incremental cost effectiveness ratio of £8300 relative to best care.
Conclusions Spinal manipulation is a cost effective addition to “best care” for back pain in general practice. Manipulation alone probably gives better value for money than manipulation followed by exercise.
doi:10.1136/bmj.38282.607859.AE
PMCID: PMC535455  PMID: 15556954
4.  Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial 
BMJ : British Medical Journal  2005;330(7502):1239.
Objective To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain.
Design Economic evaluation alongside a pragmatic randomised controlled trial.
Setting Secondary care.
Participants 349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002.
Main outcome measures Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY.
Results At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be £7830 (SD £5202) in the surgery group and £4526 (SD £4155) in the intensive rehabilitation arm, a significant difference of £3304 (95% confidence interval £2317 to £4291). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (–0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be £48 588 per QALY gained (–£279 883 to £372 406).
Conclusion Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change—for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.
doi:10.1136/bmj.38441.429618.8F
PMCID: PMC558091  PMID: 15911536
5.  Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial 
Lancet  2011;378(9802):1560-1571.
Summary
Background
Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control).
Methods
1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406.
Findings
851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06–2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25–1·86]), equating to effect sizes of 0·32 (0·19–0·45) and 0·19 (0·04–0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group.
Interpretation
The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care.
Funding
Arthritis Research UK.
doi:10.1016/S0140-6736(11)60937-9
PMCID: PMC3208163  PMID: 21963002
6.  Improvement in Automatic Postural Coordination Following Alexander Technique Lessons in a Person With Low Back Pain 
Physical therapy  2005;85(6):565-578.
Background and Purpose
The relationship between abnormal postural coordination and back pain is unclear. The Alexander Technique (AT) aims to improve postural coordination by using conscious processes to alter automatic postural coordination and ongoing muscular activity, and it has been reported to reduce low back pain. This case report describes the use of the AT with a client with low back pain and the observed changes in automatic postural responses and back pain.
Case Description
The client was a 49-year-old woman with a 25-year history of left-sided, idiopathic, lumbrosacral back pain. Automatic postural coordination was measured using a force plate during horizontal platform translations and one-legged standing.
Outcomes
The client was tested monthly for 4 months before AT lessons and for 3 months after lessons. Before lessons, she consistently had laterally asymmetric automatic postural responses to translations. After AT lessons, the magnitude and asymmetry of her responses and balance improved and her low back pain decreased.
Discussion
Further research is warranted to study whether AT lessons improve low back pain–associated abnormalities in automatic postural coordination and whether improving automatic postural coordination helps to reduce low back pain. [Cacciatore TW, Horak FB, Henry SM. Improvement in automatic postural coordination following Alexander Technique lessons in a person with low back pain.
PMCID: PMC1351283  PMID: 15921477
Back pain; Balance; Motor control; Motor learning; Posture
7.  A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis 
BMJ : British Medical Journal  2006;333(7569):626.
Objective To evaluate the cost effectiveness of acupuncture in the management of persistent non-specific low back pain.
Design Cost effectiveness analysis of a randomised controlled trial.
Setting Three private acupuncture clinics and 18 general practices in York, England.
Participants 241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration.
Interventions Ten individualised acupuncture treatments over three months from acupuncturists trained in traditional Chinese medicine (n = 160) or usual care only (n = 81).
Main outcome measure Incremental cost per quality adjusted life year (QALY) gained over two years.
Results Total costs to the United Kingdom's health service during the two year study period were higher on average for the acupuncture group (£460; €673; $859) than for the usual care group (£345) because of the costs associated with initial treatment. The mean incremental health gain from acupuncture at 12 months was 0.012 QALYs (95% confidence interval -0.033 to 0.058) and at 24 months was 0.027 QALYs (-0.056 to 0.110), leading to a base case estimate of £4241 per QALY gained. This result was robust to sensitivity analysis. The probabilistic sensitivity analysis showed acupuncture to have a more than 90% chance of being cost effective at a £20 000 cost per QALY threshold.
Conclusion A short course of traditional acupuncture for persistent non-specific low back pain in primary care confers a modest health benefit for minor extra cost to the NHS compared with usual care. Acupuncture care for low back pain seems to be cost effective in the longer term.
Trial registration ISRCTN80764175.
doi:10.1136/bmj.38932.806134.7C
PMCID: PMC1570795  PMID: 16980315
8.  Lifestyle interventions for knee pain in overweight and obese adults aged ≥45: economic evaluation of randomised controlled trial 
Objective To estimate the cost effectiveness of four different lifestyle interventions for knee pain.
Design Cost utility analysis of randomised controlled trial.
Setting Five general practices in the United Kingdom.
Participants 389 adults aged ≥45 with self reported knee pain and body mass index (BMI) ≥28.
Interventions Dietary intervention plus quadriceps strengthening exercises, dietary intervention, quadriceps strengthening exercises, and leaflet provision. Participants received home visits over a two year period.
Main outcome measure Incremental cost per quality adjusted life year (QALY) gained over two years from a health service perspective.
Results Advice leaflet was associated with a mean change in cost of −£31, and a mean QALY gain of 0.085. Both strengthening exercises and dietary intervention were more effective (0.090 and 0.133 mean QALY gain, respectively) but were not cost effective. Dietary intervention plus strengthening exercises had a mean cost of £647 and a mean QALY gain of 0.147 and was estimated to have an incremental cost of £10 469 per QALY gain (relative to leaflet provision), and a 23.1% probability of being cost effective at a £20 000/QALY threshold.
Conclusion Dietary intervention plus strengthening exercises was estimated to be cost effective for individuals with knee pain, but with a large level of uncertainty.
Trial registration ISRCTN93206785.
doi:10.1136/bmj.b2273
PMCID: PMC2728802  PMID: 19690341
9.  Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial 
Trials  2009;10:96.
Background
Chronic back pain is a major public health problem and the primary reason patients seek massage treatment. Despite the growing use of massage for chronic low back pain, there have been few studies of its effectiveness. This trial will be the first evaluation of the effectiveness of relaxation massage for chronic back pain and the first large trial of a focused structural form of massage for this condition.
Methods and Design
A total of 399 participants (133 in each of three arms) between the ages of 20 and 65 years of age who have low back pain lasting at least 3 months will be recruited from an integrated health care delivery system. They will be randomized to one of two types of massage ("focused structural massage" or "relaxation massage"), or continued usual medical care. Ten massage treatments will be provided over 10 weeks. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline and after 10, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, perceived stress, and use and costs of healthcare services for back pain will also be measured. Outcomes across assigned treatment groups will be compared using generalized estimating equations, accounting for participant correlation and adjusted for baseline value, age, and sex. For both primary outcome measures, this trial will have at least 85% power to detect the presence of a minimal clinically significant difference among the three treatment groups and 91% power for pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.
Conclusion
Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain.
Trial registration
Clinical Trials.gov NCT 00371384.
doi:10.1186/1745-6215-10-96
PMCID: PMC2774684  PMID: 19843340
10.  A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial 
Annals of internal medicine  2011;155(1):1-9.
Background
Few studies have evaluated the effectiveness of massage for back pain.
Objective
To evaluate the effectiveness of two types of massage for chronic back pain.
Design
Single-blind parallel group randomized controlled trial.
Setting
Integrated health care delivery system in Seattle area.
Patients
401 persons 20 to 65 years of age with non-specific chronic low back pain.
Interventions
Ten treatments over 10 weeks of Structural Massage (intended to identify and alleviate musculoskeletal contributors to pain through focused soft-tissue manipulation) (n=132) or Relaxation Massage (intended to decrease pain and dysfunction by inducing relaxation) (n=136). Treatments provided by 27 experienced licensed massage therapists. Comparison group received continued usual care (n=133). Study presented as comparison of usual care with two types of massage.
Measurements
Primary outcomes were the Roland Disability Questionnaire (RDQ) and the Symptom Bothersomeness scale measured at 10 weeks. Outcomes also measured after 26 and 52 weeks.
Results
At 10 weeks, the massage groups had similar functional outcomes that were superior to those for usual care. The adjusted mean RDQ scores were 2.9 and 2.4 points lower for the relaxation and structural massage groups, respectively, compared to usual care (95% CIs: [1.8, 4.0] and [1.4, 3.5]). Adjusted mean symptom bothersomeness scores were 1.7 points and 1.4 points lower with relaxation and structural massage, respectively, versus usual care (95% CIs: [1.2, 2.2] and [0.8, 1.9]). The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks, but were small.
Limitations
Restricted to single site; therapists and patients not blinded to treatment.
Conclusions
This study confirms the results of smaller trials that massage is an effective treatment for chronic back pain with benefits lasting at least 6 months, and also finds no evidence of a clinically-meaningful difference in the effectiveness of two distinct types of massage.
Primary Funding Source
National Center for Complementary and Alternative Medicine
doi:10.1059/0003-4819-155-1-201107050-00002
PMCID: PMC3570565  PMID: 21727288
11.  Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467] 
Background
Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60–70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis.
Methods/Design
Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study.
In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results.
Discussion
This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment.
doi:10.1186/1472-6882-6-14
PMCID: PMC1468427  PMID: 16630342
12.  GP Participation and Recruitment of Patients to RCTs: Lessons from Trials of Acupuncture and Exercise for Low Back Pain in Primary Care 
The objective of this study was to identify factors associated with general practitioner (GP) participation and the recruitment of people to trials in primary care, based on data from two trials of interventions for treating chronic low back pain. The study was based on data from two randomized controlled trials (RCTs), one involving exercise, the other acupuncture, and subsequent reporting by GPs in a postal questionnaire. The exercise trial achieved 62% recruitment whereas the acupuncture trial achieved 100% recruitment. In both trials GPs most efficient at referring patients were those with a special interest in the subject area, and those known personally to the research team. A follow-up GP questionnaire found that both trials had maintained a high profile with over 80% of GPs, and successful recruitment strategies included project reminder letters, updates and personal contacts. Achieving target recruitment of patients in the acupuncture trial was aided by the deliberate application of lessons learned in the exercise trial, in particular the need to keep initial study entry criteria broad, with subsequent filtering undertaken by the study researcher. In addition the use of effective methods of maintaining the trial profile, the involvement of a GP advisor, the decision to maximize the recruitment of GPs early in the trial and the direct recruitment of interested individual GPs. The successful recruitment of patients to trials in primary care requires careful planning and continuous monitoring from the outset. Prior to starting recruitment, it is useful to identify previous trials in a similar environment in order to learn from their experience and optimize patient recruitment.
doi:10.1093/ecam/nen044
PMCID: PMC3137129  PMID: 18955352
13.  Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences 
BMJ : British Medical Journal  1999;319(7205):279-283.
Objective
To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities.
Design
Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients’ preferences for type of management were elicited independently of randomisation.
Participants
187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months’ duration.
Interventions
Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used.
Main outcome measures
Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services.
Results
At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients’ preferences.
Conclusions
The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective.
Key messagesPatients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmfulAn exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year laterPatients’ preferences for type of management did not affect outcomePatients in the intervention group tended to use fewer healthcare resources and took fewer days off workThis type of exercise programme should be more widely available
PMCID: PMC28176  PMID: 10426734
14.  Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial 
BACKGROUND: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture education), 2 components of massage therapy and placebo in the treatment of subacute (between 1 week and 8 months) low-back pain. METHODS: Subjects with subacute low-back pain were randomly assigned to 1 of 4 groups: comprehensive massage therapy (n = 25), soft-tissue manipulation only (n = 25), remedial exercise with posture education only (n = 22) or a placebo of sham laser therapy (n = 26). Each subject received 6 treatments within approximately 1 month. Outcome measures obtained at baseline, after treatment and at 1-month follow-up consisted of the Roland Disability Questionnaire (RDQ), the McGill Pain Questionnaire (PPI and PRI), the State Anxiety Index and the Modified Schober test (lumbar range of motion). RESULTS: Of the 107 subjects who passed screening, 98 (92%) completed post-treatment tests and 91 (85%) completed follow-up tests. Statistically significant differences were noted after treatment and at follow-up. The comprehensive massage therapy group had improved function (mean RDQ score 1.54 v. 2.86-6.5, p < 0.001), less intense pain (mean PPI score 0.42 v. 1.18-1.75, p < 0.001) and a decrease in the quality of pain (mean PRI score 2.29 v. 4.55-7.71, p = 0.006) compared with the other 3 groups. Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function. At 1-month follow-up 63% of subjects in the comprehensive massage therapy group reported no pain as compared with 27% of the soft-tissue manipulation group, 14% of the remedial exercise group and 0% of the sham laser therapy group. INTERPRETATION: Patients with subacute low-back pain were shown to benefit from massage therapy, as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists.
PMCID: PMC1231369  PMID: 10906914
15.  Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial 
BMJ : British Medical Journal  2003;326(7395):911.
Objective
To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain.
Design
Economic evaluation alongside a randomised controlled trial.
Setting
Primary care.
Participants
183 patients with neck pain for at least two weeks recruited by 42 general practitioners and randomly allocated to manual therapy (n=60, spinal mobilisation), physiotherapy (n=59, mainly exercise), or general practitioner care (n=64, counselling, education, and drugs).
Main outcome measures
Clinical outcomes were perceived recovery, intensity of pain, functional disability, and quality of life. Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year. Differences in mean costs between groups, cost effectiveness, and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques.
Results
The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks, but differences were negligible by follow up at 52 weeks. The total costs of manual therapy (€447; £273; $402) were around one third of the costs of physiotherapy (€1297) and general practitioner care (€1379). These differences were significant: P<0.01 for manual therapy versus physiotherapy and manual therapy versus general practitioner care and P=0.55 for general practitioner care versus physiotherapy. The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care.
Conclusions
Manual therapy (spinal mobilisation) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner.
What is already known on this topicThe cost of treating neck pain is considerableMany conservative interventions are available, such as prescription drugs, yet their cost effectiveness has not been evaluatedNo randomised trials of conservative treatment for neck pain have so far included an economic evaluationWhat this study addsManual therapy is more effective and less costly than physiotherapy or care by a general practitioner for treating neck painPatients undergoing manual therapy recovered more quickly than those undergoing the other interventions
PMCID: PMC153837  PMID: 12714472
16.  Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649] 
Background
Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably.
Methods
In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation.
Discussion
No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.
doi:10.1186/1471-2474-5-45
PMCID: PMC535932  PMID: 15560843
17.  Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial 
Objective To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain.
Design Economic evaluation alongside a randomised controlled trial with 12 months’ follow-up.
Setting Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9.
Participants 134 adults aged 18-65 sick listed because of chronic low back pain: 66 were randomised to integrated care and 68 to usual care.
Interventions Integrated care consisted of a workplace intervention based on participatory ergonomics, with involvement of a supervisor, and a graded activity programme based on cognitive behavioural principles. Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines.
Main outcome measures The primary outcome was duration until sustainable return to work. The secondary outcome was quality adjusted life years (QALYs), measured using EuroQol.
Results Total costs in the integrated care group (£13 165, SD £13 600) were significantly lower than in the usual care group (£18 475, SD £13 616). Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained. The cost-benefit analyses showed that every £1 invested in integrated care would return an estimated £26. The net societal benefit of integrated care compared with usual care was £5744.
Conclusions Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs, increase effectiveness of care, improve quality of life, and improve function on a broad scale. Integrated care therefore has large gains for patients and society as well as for employers.
doi:10.1136/bmj.c6414
PMCID: PMC2995018  PMID: 21118874
18.  United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care 
BMJ : British Medical Journal  2004;329(7479):1377.
Objective To estimate the effect of adding exercise classes, spinal manipulation delivered in NHS or private premises, or manipulation followed by exercise to “best care” in general practice for patients consulting with back pain.
Design Pragmatic randomised trial with factorial design.
Setting 181 general practices in Medical Research Council General Practice Research Framework; 63 community settings around 14 centres across the United Kingdom.
Participants 1334 patients consulting their general practices about low back pain.
Main outcome measures Scores on the Roland Morris disability questionnaire at three and 12 months, adjusted for centre and baseline scores.
Results All groups improved over time. Exercise improved mean disability questionnaire scores at three months by 1.4 (95% confidence interval 0.6 to 2.1) more than “best care.” For manipulation the additional improvement was 1.6 (0.8 to 2.3) at three months and 1.0 (0.2 to 1.8) at 12 months. For manipulation followed by exercise the additional improvement was 1.9 (1.2 to 2.6) at three months and 1.3 (0.5 to 2.1) at 12 months. No significant differences in outcome occurred between manipulation in NHS premises and in private premises. No serious adverse events occurred.
Conclusions Relative to “best care” in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.
doi:10.1136/bmj.38282.669225.AE
PMCID: PMC535454  PMID: 15556955
19.  Effects of preferred-exercise prescription compared to usual exercise prescription on outcomes for people with non-specific low back pain: a randomized controlled trial [ACTRN12608000524392] 
Background
Non-specific chronic low back pain (NSCLBP) has become a significant problem due to high healthcare utilization, rising costs of care and perceived limitations of effectiveness of many current treatments. Systematic reviews have repeatedly concluded that, on average across participants, exercise for NSCLBP appears effective in decreasing pain and improving function. Not all people with NSCLBP benefit from exercise programs and it would assist care-providers and care-seekers if factors that impact on program effectiveness and success were identified.
Methods and design
The study will be a randomised controlled trial comparing an exercise rehabilitation program informed by a participant preferences questionnaire compared to a program without this guideline for patients with chronic low back pain. A sample of 150 patients will be recruited in Melbourne, Australia through community-based healthcare clinics that provide supervised exercise rehabilitation programs for people with non-specific chronic low back pain. Clinicians will be randomly assigned to exercise preferences questionnaire or no questionnaire and participants will be allocated in a concealed manner. A qualitative focus group study of exercise instructor feedback about the exercise preferences instrument will be embedded in the research design. Two qualitative focus group studies will also be conducted for participants in the intervention and the control groups to obtain feedback about participants' experiences of the two types of exercise programs. The primary outcomes will be functional ability, pain, fear avoidance, exercise adherence.
Discussion
This trial will evaluate the effectiveness of individualised exercise prescription compared to usual exercise prescription for NSCLP and, using feedback following the trial, refine the exercise preferences questionnaire.
doi:10.1186/1471-2474-10-14
PMCID: PMC2642754  PMID: 19173747
20.  Increased dynamic regulation of postural tone through Alexander Technique training 
Human movement science  2010;30(1):74-89.
Gurfinkel and colleagues (2006) recently found that healthy adults dynamically modulate postural muscle tone in the body axis during anti-gravity postural maintenance and that this modulation is inversely correlated with axial stiffness. Our objective in the present study was to investigate whether dynamic modulation of axial postural tone can change through training. We examined whether teachers of the Alexander Technique (AT), who undergo “long-term” (3-year) training, have greater modulation of axial postural tone than matched control subjects. In addition, we performed a longitudinal study on the effect of “short-term” (10-week) AT training on the axial postural tone of individuals with low back pain (LBP), since short term AT training has previously been shown to reduce LBP. Axial postural tone was quantified by measuring the resistance of the neck, trunk and hips to small (±10°), slow (1°/s) torsional rotation during stance. Modulation of tone was determined by the torsional resistance to rotation (peak-to-peak, phase-advance, and variability of torque) and axial muscle activity (EMG). Peak-to-peak torque was lower (~50%), while phase-advance and cycle-to-cycle variability were enhanced for AT teachers compared to matched control subjects at all levels of the axis. In addition, LBP subjects decreased trunk and hip stiffness following short-term AT training compared to a control intervention. While changes in static levels of postural tone may have contributed to the reduced stiffness observed with the AT, our results suggest that dynamic modulation of postural tone can be enhanced through long-term training in the AT, which may constitute an important direction for therapeutic intervention.
doi:10.1016/j.humov.2010.10.002
PMCID: PMC3074502  PMID: 21185100
Muscle Tone; Posture; Alexander Technique; Low Back Pain; Motor Processes
21.  Deep Tissue Massage and Nonsteroidal Anti-Inflammatory Drugs for Low Back Pain: A Prospective Randomized Trial 
The Scientific World Journal  2014;2014:287597.
Objective. To investigate whether chronic low back pain therapy with deep tissue massage (DTM) gives similar results to combined therapy consisting of DTM and non-steroid anti-inflammatory drugs (NSAID). Design. Prospective controlled randomized single blinded trial. Settings. Ambulatory care of rehabilitation. Participants. 59 patients, age 51.8 ± 9.0 years, with chronic low back pain. Interventions. 2 weeks of DTM in the treatment group (TG) versus 2 weeks of DTM combined with NSAID in the control group (CG). Main Outcome Measures. Visual analogue scale, Oswestry disability index (ODI), and Roland-Morris questionnaire (RM). Results. In both the TG and the CG, a significant pain reduction and function improvement were observed. VAS decreased from 58.3 ± 18.2 to 42.2 ± 21.1 (TG) and from 51.8 ± 18.8 to 30.6 ± 21.9 (CG). RM value decreased from 9.8 ± 5.1 to 6.4 ± 4.4 (TG), and from 9.3 ± 5.5 to 6.1 ± 4.6 (CG). ODI value decreased from 29.2 ± 17.3 to 21.4 ± 15.1 (TG) and from 21.4 ± 9.4 to 16.6 ± 9.4 (CG). All pre-post-treatment differences were significant; however, there was no significant difference between the TG and the CG. Conclusion. DTM had a positive effect on reducing pain in patients with chronic low back pain. Concurrent use of DTM and NSAID contributed to low back pain reduction in a similar degree that the DTM did.
doi:10.1155/2014/287597
PMCID: PMC3953439
22.  Community falls prevention for people who call an emergency ambulance after a fall: an economic evaluation alongside a randomised controlled trial 
Age and Ageing  2012;41(5):635-641.
Objective: we estimated the cost-effectiveness of a community falls prevention service compared with usual care from a National Health Service and personal social services perspective over the 12 month trial period.
Design: a cost-effectiveness and cost utility analysis alongside a randomised controlled trial
Setting: community.
Participants: people over 60 years of age living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital.
Interventions: referral to community fall prevention services or usual health and social care.
Measurements: incremental cost per fall prevented and incremental cost per Quality-Adjusted Life Years (QALYs)
Results: a total of 157 participants (82 interventions and 75 controls) were used to perform the economic evaluation. The mean difference in NHS and personal social service costs between the groups was £-1,551 per patient over 1 year (95% CI: £-5,932 to £2,829) comparing the intervention and control groups. The intervention patients experienced on average 5.34 fewer falls over 12 months (95% CI: −7.06 to −3.62). The mean difference in QALYs was 0.070 (95% CI: −0.010 to 0.150) in favour of the intervention group.
Conclusion: the community falls prevention service was estimated to be cost-effective in this high-risk group. Current Controlled Trials ISRCTN67535605. (controlled-trials.com)
doi:10.1093/ageing/afs071
PMCID: PMC3424053  PMID: 22695789
economic evaluation; falls prevention; older people
23.  Treatment compliance and effectiveness of a cognitive behavioural intervention for low back pain: a complier average causal effect approach to the BeST data set 
Background
Group cognitive behavioural intervention (CBI) is effective in reducing low-back pain and disability in comparison to advice in primary care. The aim of this analysis was to investigate the impact of compliance on estimates of treatment effect and to identify factors associated with compliance.
Methods
In this multicentre trial, 701 adults with troublesome sub-acute or chronic low-back pain were recruited from 56 general practices. Participants were randomised to advice (control n = 233) or advice plus CBI (n = 468). Compliance was specified a priori as attending a minimum of three group sessions and the individual assessment. We estimated the complier average causal effect (CACE) of treatment.
Results
Comparison of the CACE estimate of the mean treatment difference to the intention-to-treat (ITT) estimate at 12 months showed a greater benefit of CBI amongst participants compliant with treatment on the Roland Morris Questionnaire (CACE: 1.6 points, 95% CI 0.51 to 2.74; ITT: 1.3 points, 95% CI 0.55 to 2.07), the Modified Von Korff disability score (CACE: 12.1 points, 95% CI 6.07 to 18.17; ITT: 8.6 points, 95% CI 4.58 to 12.64) and the Modified von Korff pain score (CACE: 10.4 points, 95% CI 4.64 to 16.10; ITT: 7.0 points, 95% CI 3.26 to 10.74). People who were non-compliant were younger and had higher pain scores at randomisation.
Conclusions
Treatment compliance is important in the effectiveness of group CBI. Younger people and those with more pain are at greater risk of non-compliance.
Trial registration
Current Controlled Trials ISRCTN54717854
doi:10.1186/1471-2474-15-17
PMCID: PMC3897907  PMID: 24423146
Compliance; CACE analysis; Low back pain; Cognitive behaviour therapy
24.  Efficacy of movement control exercises versus general exercises on recurrent sub-acute nonspecific low back pain in a sub-group of patients with movement control dysfunction. protocol of a randomized controlled trial 
Background
Practice guidelines recommend various types of exercise for chronic back pain but there have been few head-to-head comparisons of these interventions. General exercise seems to be an effective option for management of chronic low back pain (LBP) but very little is known about the management of a sub-acute LBP within sub-groups.
Recent research has developed clinical tests to identify a subgroup of patients with chronic non-specific LBP who have movement control dysfunction (MD).
Method/Design
We are conducting a randomized controlled trial (RCT) to compare the effects of general exercise and specific movement control exercise (SMCE) on disability and function in patients with MD within recurrent sub-acute LBP. The main outcome measure is the Roland Morris Disability Questionnaire.
Discussion
European clinical guideline for management of chronic LBP recommends that more research is required to develop tools to improve the classification and identification of specific clinical sub-groups of chronic LBP patients. Good quality RCTs are then needed to determine the effectiveness of specific interventions aimed at these specific target groups. This RCT aims to test the hypothesis whether patients within a sub-group of MD benefit more through a specific individually tailored movement control exercise program than through general exercises.
doi:10.1186/1471-2474-13-55
PMCID: PMC3353835  PMID: 22494776
25.  Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care 
BMJ : British Medical Journal  2004;328(7442):747.
Objective To evaluate the cost effectiveness of acupuncture in the management of chronic headache.
Design Cost effectiveness analysis of a randomised controlled trial.
Setting General practices in England and Wales.
Participants 401 patients with chronic headache, predominantly migraine.
Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months from appropriately trained physiotherapists, or to usual care alone.
Main outcome measure Incremental cost per quality adjusted life year (QALY) gained.
Results Total costs during the one year period of the study were on average higher for the acupuncture group (£403; $768; €598) than for controls (£217) because of the acupuncture practitioners' costs. The mean health gain from acupuncture during the one year of the trial was 0.021 quality adjusted life years (QALYs), leading to a base case estimate of £9180 per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial.
Conclusions Acupuncture for chronic headache improves health related quality of life at a small additional cost; it is relatively cost effective compared with a number of other interventions provided by the NHS.
doi:10.1136/bmj.38033.896505.EB
PMCID: PMC381327  PMID: 15023830

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