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
Protocol serial number	N0283184549
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Sussex NHS Research Consortium (UK)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Roland and Morris Disability Questionnaire.
Key secondary outcome measure(s)	1. Visual Analogue Scale (for pain) 2. Patient Specific Functional Scale 3. Self-Efficacy Questionnaire
Completion date	01/06/2007
Reason abandoned (if study stopped)	Lack of staff and change in clinical practice/evidence base

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Not Specified
Target sample size at registration	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

Worthing & Southlands Hospitals NHS Trust

Worthing
BN11 2DH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan