A randomised factorial trial for patients with recurrent and chronic back pain of GP exercise prescription, the Alexander Technique and massage

Completed

• Conditions: Primary care; Musculoskeletal Diseases; Recurrent and chronic back pain

• Registration Number: ISRCTN26416991
• Lead Sponsor: niversity of Southampton (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 579

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.