Contact information
Type
Scientific
Primary contact
Mr Chris Mercer
ORCID ID
Contact details
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
+44 01273 455622 x 3489
christopher.mercer@wash.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0283184549
Study information
Scientific title
Acronym
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.
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
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
Phase
Not Specified
Drug names
Primary outcome measures
Roland and Morris Disability Questionnaire.
Secondary outcome measures
1. Visual Analogue Scale (for pain)
2. Patient Specific Functional Scale
3. Self-Efficacy Questionnaire
Overall trial start date
01/09/2006
Overall trial end date
01/06/2007
Reason abandoned
Lack of staff and change in clinical practice/evidence base
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
80
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sussex NHS Research Consortium (UK)
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