Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes