ISRCTN78417198CompletedNot Applicable
The effectiveness of motorised lumbar traction in the management of lumbosacral nerve root pai
niversity of Ulster (UK)0 sites30 target enrollmentStarted: March 21, 2007Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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)
Investigators
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