Condition category
Musculoskeletal Diseases
Date applied
01/07/2003
Date assigned
01/07/2003
Last edited
04/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Elaine May

ORCID ID

Contact details

Primary Care Sciences Research Centre
Keele University
Keele
ST5 5BG
United Kingdom
+44 (0)1782 583916
e.m.hay@cphc.keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M RB 218233

Study information

Scientific title

Acronym

Study hypothesis

To compare the clinical effectiveness, in primary care, of a brief pain management programme delivered by physiotherapists with that of a programme of spinal manual physiotherapy in the treatment of non-specific low back pain of less than 12 weeks duration.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute low back pain

Intervention

1. A brief pain management programme with no 'hands on' physiotherapy but focusing on education to change behaviour and attitudes, in addition to exercises to increase fitness.
2. A course of "hands on" spinal manual therapy plus specific back exercises prescribed on the basis of a detailed assessment of spinal pain, mobility and function by the physiotherapist.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome was change in self-reported back pain related disability at 12 months as measured on the Roland and Morris Disability Questionnaire.

Secondary outcome measures

1. Participants’ global assessment of change compared with baseline
2. Pain location (body chart)
3. Rating of pain severity (visual analogue scale [VAS]) and pain nature (short form McGill pain questionnaire)
4. Psychological distress (the distress and risk assessment method [DRAM])
5. Fear of movement (Tampa scale of kinesiophobia), coping strategies (coping strategies questionnaire)
6. Satisfaction with treatment (VAS)
7. Days off work since start of current episode
8. Co-interventions (health care utilisation and medication usage)

Overall trial start date

01/07/2000

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 64 years inclusive
2. Acute episode of low back pain of less than 12 weeks duration
3. First or second consultation with general practitioner (GP)
4. Able to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

402

Participant exclusion criteria

1. On long term sick leave for low back pain
2. Already seen by other health care professional (e.g. physio) for this episode of back pain prior to randomisation
3. Diagnosis of osteoporosis or inflammatory arthritis
4. Systemic steroid therapy for more than three months duration
5. Pregnancy
6. Undergoing current treatment for cancer
7. Terminal illness
8. Previous hip or back surgery or fracture
9. Abdominal surgery within the last three months
10. Roland and Morris Disability Questionnaire score (primary outcome measure) less than 2

Recruitment start date

01/07/2000

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Sciences Research Centre
Keele
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

Keele University
Keele
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Charity

Funder name

The National Lotteries Charities Board (via North Staffordshire Medical Institute) (UK) - Project No. RB218223, £191,227

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North Staffordshire Primary Care Research Consortium (UK) £112,516

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15950716

Publication citations

  1. Results

    Hay EM, Mullis R, Lewis M, Vohora K, Main CJ, Watson P, Dziedzic KS, Sim J, Minns Lowe C, Croft PR, Comparison of physical treatments versus a brief pain-management programme for back pain in primary care: a randomised clinical trial in physiotherapy practice., Lancet, 365, 9476, 2024-2030, doi: 10.1016/S0140-6736(05)66696-2.

Additional files

Editorial Notes