Can the Roland and Morris disability questionnaire be used to predict the response to physiotherapy treatment in chronic low back pain patients?
ISRCTN | ISRCTN60552623 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN60552623 |
Secondary identifying numbers | N0283184549 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 05/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Chris Mercer
Scientific
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Phone | +44 01273 455622 x 3489 |
---|---|
christopher.mercer@wash.nhs.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | The aim of the pilot study is to see if it is possible to predict which patients with low back pain respond best to certain types of physiotherapy treatment. These treatments will be manipulation plus exercise, a spinal stability class and a general back class. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Low back pain |
Intervention | 1. Manual therapy and exercise 2. Stability class 3. General back class Added 21 August 2008: the trial was stopped before it started, firstly due to a staffing issue locally, then due to a change in clinical practice/evidence base. |
Intervention type | Other |
Primary outcome measure | Roland and Morris Disability Questionnaire. |
Secondary outcome measures | 1. Visual Analogue Scale (for pain) 2. Patient Specific Functional Scale 3. Self-Efficacy Questionnaire |
Overall study start date | 01/09/2006 |
Completion date | 01/06/2007 |
Reason abandoned (if study stopped) | Lack of staff and change in clinical practice/evidence base |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Not Specified |
Target number of participants | 80 |
Key inclusion criteria | 1. Aged 18-65 2. Non-specific LBP>3 month duration 3. Non-specific LBP or leg symptoms of spinal origin>3 months 4. Acute exacerbation of chronic LBP 5. Patients with longstanding, stable neurological deficit from LBP eg sensory loss, minor motor weakness at one level, loss of reflex at one level 6. Medically fit to exercise 7. Ability to understand spoken and written English 8. Suitable for working in group environment 9. Consented to participate These are recognised inclusion criteria for similar trials with similar cohorts of patients, making the study and its findings potentially reflective of other work in this field. |
Key exclusion criteria | 1. Pregnancy 2. Acute nerve root signs and symptoms 3. Spinal red flags as defined by RCGP and ARMA guidelines 4. Not meeting inclusion criteria |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
---|---|
dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Sussex NHS Research Consortium (UK)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |