| Source of record | UK Trials |
| ISRCTN | ISRCTN60552623 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0283184549 |
| Public title | Can the Roland and Morris disability questionnaire be used to predict the response to physiotherapy treatment in chronic low back pain patients? |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Low back pain |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 |
| Patient information material |
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| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/06/2007 |
| Status of trial | Completed |
| Target number of participants | 80 |
| Interventions | [A] Manual therapy and exercise [B] Stability class [C] General back class |
| Primary outcome measure(s) | Roland and Morris Disability Questionnaire. |
| Secondary outcome measure(s) | 1. Visual Analogue Scale (for pain) 2. Patient Specific Functional Scale 3. Self-Efficacy Questionnaire |
| Sources of funding | Sussex NHS Research Consortium |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall London United Kingdom SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Chris Mercer |
| Contact details | Worthing & Southlands Hospitals NHS Trust Worthing Hospital Lyndhurst Road
Worthing United Kingdom BN11 2DH |
| Contact telephone | +44 01273 455622 x 3489 |
| Contact fax | +44 |
| Contact email | christopher.mercer@wash.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN60552623 |
| Date last extracted from ISRCTN register | 17/04/2008 |