Contact information
Type
Scientific
Primary contact
Dr Paul S Little
ORCID ID
Contact details
Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1062
psl3@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0001104
Study information
Scientific title
Acronym
ATEAM trial
Study hypothesis
The aims of the trial are to assess the effectiveness and cost effectiveness when compared to normal care of:
1. A longer course (24) of lessons in the Alexander Technique (AT)
2. A an introductory course of lessons
3. GP advice and 'prescription' to take exercise in the free setting
4. A course of massage
A secondary aim is to assess to what extent the effect of AT is specific to learning how to change personal and body use. Patients who have attended their GP within the last 5 years for back pain will be identified from GP computerised databases of 54 practices. Patients with current Rowland low back pain score of 4 or more (i.e. patients with recurrent or chronic back pain) and physically able to exercise will be randomised to one of eight groups defined by two factors:
1. AT factor:
1.1. Introductory AT
1.2. Longer AT
1.3. Massage
1.4. Normal care
2. Exercise prescription factor:
2.1. GP exercise prescription with follow-up
2.2. No prescription
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Primary care
Intervention
Alexander Technique (AT) factor:
1. Normal management (control):
This group provides a realistic comparator, particularly for the economic component of the trial (so that the marginal costs of the intervention groups are realistically assessed). All trial participants will continue to be free to see their GP who will perform investigations, provide treatment - including drug treatments - or refer as they would normally (and this will be documented).
2. Longer course of lessons in the AT and book:
The practical content of each lesson will vary according to the needs and limitations of each participant. What has been taught, the practical procedures used and the participant's progress and difficulties will be recorded on standard sheets. After the first lesson and in the sixth week the Alexander teacher will record how useful they consider AT has been for each subject. Each participant will be encouraged to keep a record of the time outside lessons specifically devoted to AT. Each session will last 30 - 40 min. A standard text describing AT will also be given to each participant at the beginning of the course. The teachers will be included in the trial only if they have undergone a 3 year training at a STAT approved course; are members of STAT; and have at least 3 years post qualification experience. The aim in the longer course of lessons is to provide a much more comprehensive course in line with STATs recommendations for a new pupil. Up to 24 lessons will be provided at the teachers normal place of work: the initial course over 5 months (6 weeks at 2/week, 6 weeks at 1/week, 8 weeks at 1/2weeks) will be followed by two lessons for revision at 7 and 9 months.
3. Introductory course of AT lessons and book:
This group represents a short intervention that has a good chance of being considered by NHS purchasers, and whose costs are in line with the likely costs of interventions from other major trials (e.g. UK BEAM). The aim is to provide an introductory set of lessons (six lessons), and not a comprehensive programme, with material to help understand AT. The first four lessons will be at twice weekly intervals and subsequent lessons weekly. The participant would also be free then to assess their own progress, and choose whether to fund further lessons themselves - as happens in normal practice. (The concern here is that the less affluent participants would be prevented from taking further lessons: what further lessons participants had, and the equity of this approach would therefore be key outcomes when assessing the effectiveness for this group.)
4. Therapeutic massage:
Therapeutic massage is widely used, is credible to patients and therapists. It will provide an attention and touch comparison for non-specific aspects of AT teaching, and is also important to assess since it may provide benefit in its own right. Patients will receive six sessions in accordance with current normal clinical practice (thus being equivalent to the introductory AT group). As with the introductory course of AT, patients will be free to have further sessions of massage at their own discretion, which mimics what would happen in normal practice. Any further sessions will be documented.
GP Exercise Prescription factor:
Half the patients in each of the AT factor groups will be randomised to an appointment with a GP and follow-up nurse consultations. The GP appointment will be scheduled 6 weeks into the trial to maximise the likely benefit for those groups where exercise and AT are combined. The exercise 'prescription' will use the same format as the feasibility study (see above): the GP will specify the time and frequency of exercise, the date to start on the sheet, and give the sheet to the participant to display in a prominent place around the house. The GP will briefly discuss a list structured points based on previous behavioural literature: the importance of exercise; finding a regular exercise to incorporate into daily life (either walking or equivalent); aiming for a target of 30 min walking 5 times per week according to current national guidelines; and anticipating relapse. Three follow-up appointments with a practice nurse (i.e. four in total) will deal with the same issues as the GP, provide reinforcement and encourage maintenance.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary analysis will be an analysis of covariance for a factorial study at 3 months and 1 year for the principal outcomes between groups (Rowland score; days of back pain).
Secondary outcome measures
Controlling for potentially confounding baseline values and for cluster effects, and transforming data as appropriate. Although we are not expecting interaction between factors we will assess interaction and if significant will report outcomes for groups seperately. This trial will detect large interactions, but if smaller non-significant interactions looked likely they would have to be the subject of further study. If significant and multiple cluster effects are demonstrated a multi-level modelling approach will be used. Secondary analysis will assess the prognostic value of clinical and psychological variables at baseline in predicting outcome at 1 year. The economic evaluation will take the form of a cost-consequence analysis and if appropriate a cost-effectiveness and cost-utility analysis.
Overall trial start date
01/12/2001
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The entry criteria are similar to the UK BEAM trial to facilitate comparison, except for this trial all patients have chronic or recurrent pain
2. The population will be aged 18 to 65 who presented in primary care with low back pain more than 3 months previously, who currently score 4 or more on the Roland Scale and have had back pain for 3 weeks (ie to exclude short-lived recurrence)
3. Participants will need to be fluent in English and able to read and write (to complete the outcome measures)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
579
Participant exclusion criteria
1. Previous experience of AT
2. The over 65s (serious spinal pathology more likely)
3. Clinical indicators of serious spinal pathology
4. Current nerve root pain (below knee in dermatomal distribution) or previous spinal surgery (outcome may be very different, and groups too small to analyse)
5. History of psychosis or major alcohol abuse (difficulty completing outcomes)
6. Perceived inability to walk 100 metres (exercise difficult)
7. Exercising for 30 min three times a week or above
8. Pregnancy
9. Pending litigation
Recruitment start date
01/12/2001
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
University Road
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 5000
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18713809
2. 2008 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/19074232
3. 2009 results on patient views in http://www.ncbi.nlm.nih.gov/pubmed/20032168
Publication citations
-
Results
Little P, Lewith G, Webley F, Evans M, Beattie A, Middleton K, Barnett J, Ballard K, Oxford F, Smith P, Yardley L, Hollinghurst S, Sharp D, Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain., BMJ, 2008, 337, a884.
-
Economic evaluation
Hollinghurst S, Sharp D, Ballard K, Barnett J, Beattie A, Evans M, Lewith G, Middleton K, Oxford F, Webley F, Little P, Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation., BMJ, 2008, 337, a2656.
-
Results on patient views
Yardley L, Dennison L, Coker R, Webley F, Middleton K, Barnett J, Beattie A, Evans M, Smith P, Little P, Patients' views of receiving lessons in the Alexander technique and an exercise prescription for managing back pain in the ATEAM trial., Fam Pract, 2010, 27, 2, 198-204, doi: 10.1093/fampra/cmp093.