The effectiveness of motorised lumbar traction in the management of lumbosacral nerve root pain
| ISRCTN | ISRCTN78417198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78417198 |
| Secondary identifying numbers | N/A |
- 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
Scientific
School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
| Phone | +44 (0)28 9036 8284 |
|---|---|
| jh.gracey@ulster.ac.uk |
Study information
| Study design | Pragmatic single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/2004 |
| Completion date | 26/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- Northern Ireland
- United Kingdom
Study participating centre
School of Health Sciences
Newtownabbey
BT37 0QB
United Kingdom
BT37 0QB
United Kingdom
Sponsor information
University of Ulster (UK)
University/education
University/education
c/o Dr Annette Harte
School of Health Sciences
Shore Road
Newtownabbey
BT37 0QB
Northern Ireland
United Kingdom
| Phone | +44 (0)28 9036 6650 |
|---|---|
| aa.harte@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk |
"ROR" |
https://ror.org/01yp9g959 |
Funders
Funder type
University/education
University of Ulster (UK)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Ulster, Ulster, Ulster Uni, UU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
