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

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Phone +44 01273 455622 x 3489
Email christopher.mercer@wash.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedMusculoskeletal Diseases: Low back pain
Intervention1. 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 typeOther
Primary outcome measureRoland and Morris Disability Questionnaire.
Secondary outcome measures1. Visual Analogue Scale (for pain)
2. Patient Specific Functional Scale
3. Self-Efficacy Questionnaire
Overall study start date01/09/2006
Completion date01/06/2007
Reason abandoned (if study stopped)Lack of staff and change in clinical practice/evidence base

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexNot Specified
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2006
Date of final enrolment01/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan