Condition category
Musculoskeletal Diseases
Date applied
25/01/2007
Date assigned
21/03/2007
Last edited
16/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacqueline Gracey

ORCID ID

Contact details

School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0)28 9036 8284
jh.gracey@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To compare the effectiveness of two treatment protocols (manual therapy, exercise and advice with or without traction) in the management of acute/subacute Low Back Pain (LBP) with nerve root involvement.

Ethics approval

Approval received from the local ethics committee at the University Ulster in March 2004.

Study design

Pragmatic single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Low back pain

Intervention

Group 1: Manual therapy, exercise and advice
Group 2: Manual therapy, exercise, advice and continous lumbar traction

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Roland Morris Disability Questionnaire
2. McGill pain questionnaire
3. Acute low back pain screening questionnaire
4. Short Form health survey 36

Secondary outcome measures

1. Visual analogue scale - pain
2. Medication diary
3. Percentage improved - subjective patient score

Overall trial start date

01/03/2004

Overall trial end date

26/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 65 years of age (male and female), presenting with acute/sub-acute LBP with accompanying radiculopathy
2. ‘Nerve root’ was identified by the presence of:
a. dermatomal pain distribution radiating below the knee (one or both limbs)
b. sharp/severe quality, often worse in the leg than back (leg pain threshold of 3/10 on Visual Analogue Scale [VAS])
With at least one of the following signs and symptoms:
c. pins and needles in the distal dermatome (where this was present patients with leg pain were accepted even if not extending below the knee)
d. increased pain in the leg on coughing, sneezing or straining
e. neurological deficit, i.e., decreased muscle strength/sensory loss/reflex loss
f. positive straight leg raise test stretch, i.e., limb pain reproduced on test
3. Acute/sub acute LBP, defined as LBP of less than 12 weeks duration, or a recurrent episode with a pain free period of at least three months prior to the onset of this episode. Only one study has considered recovery rates with ‘sciatica’ and reported that both back and leg pain decreased, on average, by 69%, and disability decreased by 57% within one month from onset. Current physiotherapy practice would suggest that treatment begins as soon as possible; therefore patients were accepted after four weeks of onset of leg pain
4. Able to attend for physiotherapy two to three times a week for four to six weeks
5. Patients were literate with English as their first language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Previous spinal surgery
2. Formal therapeutic or medical intervention within the last three months (e.g., epidural injection, facet joint block, physiotherapy etc..,)
3. Co-existing conditions (anklyosing spondolytitis, rheumatoid arthritis, spinal stenosis [diagnosed], spondolythesis, recent spinal fracture, spinal tumor or a patient where secondary metastases was suspected)
4. Concomitant severe medical problem preventing participation in the trial (cardiac condition, respiratory conditions, neurological disorder or organ disease)
5. Long term oral steroid intake (due to the risk of osteoporosis)
6. Current anti-coagulant therapy or blood clotting disorders
7. Pregnancy
8. History of major psychiatric illness
9. Roland Morris disability questionnaire score of below four, and/or a VAS score of less than three on a ten point scale for leg pain (to avoid floor effects)

Recruitment start date

01/03/2004

Recruitment end date

26/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health Sciences
Newtownabbey
BT37 0QB
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

c/o Dr Annette Harte
School of Health Sciences
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0)28 9036 6650
aa.harte@ulster.ac.uk

Sponsor type

University/education

Website

http://www.ulster.ac.uk

Funders

Funder type

University/education

Funder name

University of Ulster (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Ireland

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18047650

Publication citations

  1. Results

    Harte AA, Baxter GD, Gracey JH, The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study., BMC Musculoskelet Disord, 2007, 8, 118, doi: 10.1186/1471-2474-8-118.

Additional files

Editorial Notes