The effectiveness of motorised lumbar traction in the management of lumbosacral nerve root pain

ISRCTN	ISRCTN78417198
DOI	https://doi.org/10.1186/ISRCTN78417198
Protocol serial number	N/A
Sponsor	University of Ulster (UK)
Funder	University of Ulster (UK)

Submission date: 25/01/2007
Registration date: 21/03/2007
Last edited: 16/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jacqueline Gracey
Scientific

School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom

Phone	+44 (0)28 9036 8284
Email	jh.gracey@ulster.ac.uk

Study information

Primary study design	Interventional
Study design	Pragmatic single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Approval received from the local ethics committee at the University Ulster in March 2004.
Health condition(s) or problem(s) studied	Low back pain
Intervention	Group 1: Manual therapy, exercise and advice Group 2: Manual therapy, exercise, advice and continous lumbar traction
Intervention type	Other
Primary outcome measure(s)	1. Roland Morris Disability Questionnaire 2. McGill pain questionnaire 3. Acute low back pain screening questionnaire 4. Short Form health survey 36
Key secondary outcome measure(s)	1. Visual analogue scale - pain 2. Medication diary 3. Percentage improved - subjective patient score
Completion date	26/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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)
Date of first enrolment	01/03/2004
Date of final enrolment	26/02/2005

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

School of Health Sciences

Newtownabbey
BT37 0QB
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/11/2007		Yes	No