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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26416991
Enrollment
579
Registered
2001-05-02
Start date
2001-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary care Musculoskeletal Diseases Recurrent and chronic back pain

Interventions

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 i
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 STAT?s recommendations for a new pupil. Up

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026