An Open label, Randomized, Comparative Clinical Study to Evaluate the Efficacy of Hijamah bil shart (wet cupping) at Two Different Sites in the Management of Sciatica
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduction in Pain intensity and other symptoms of Sciatica.
Study Overview
Brief Summary
Diagnosed patients of Sciatica, fulfilling the inclusion and exclusion criteria, will be enrolled in the study. A written informed consent will be obtained from each patient before enrolment. Afterwards, patients will be randomized by block randomization into either of the two groups, Group A and Group B for therapeutic intervention Hijamah bil Shart.
Patients of Group A will receive Hijamah bil Shart over Lumbosacral region. 2 cups will be placed on paravertebral area at L4-L5 or L5-S1 for Hijamah.
Patients of Group B will receive Hijamah bil Shart over calf muscle and below lateral malleolus of the affected leg.
There will be 3 sittings of Hijamah fortnightly in both groups.
The patients will be assessed on assessment parameters viz. SLR, MSBQ, SBI, VAS, Goniometer, 6 minutes walk test and, Stair climbing test before and after treatment.
There will be a last follow-up on day 42 for assessment only, and no therapy will be given on this day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age- 18 to 65 years.
- •All genders.
- •Already diagnosed patients of sciatica(chronic cases) having constant pain since 3 months or more presenting with all or some of the following signs and symptoms.
- •Unilateral leg pain greater than low back pain radiating towards leg/ foot/toes.
- •Numbness and/ tingling sensation in the same distribution.
- •Positive straight-leg-raising test.
- •Pain intensity score of 30-60 mm on a 100-mm visual analog scale (VAS).
- •Willingness to accept wet cupping intervention.
Exclusion Criteria
- •Pregnant and lactating women.
- •Patients of previous back surgery or lumbar spine surgery.
- •Patients of spinal tumors, gross or fixed developmental deformity, cauda equine or vertebral fracture.
- •Pelvic or Back trauma.
- •Rheumatoid Arthritis.
- •Ankylosing spondylosis.
- •Patients of bleeding disorders.
- •Patients of anaemia (Hb less than 10 gm) Patients with Chronic liver, kidney or heart disease Motor weakness or Muscle wasting Patients suffering from Psychiatric disorders HCV and HBsAg positive patients History of stroke, severe hypertension and uncontrolled diabetes mellitus Unwilling to participate in the study.
Outcomes
Primary Outcomes
Reduction in Pain intensity and other symptoms of Sciatica.
Time Frame: Day 1 and Day 42
Improvement in Range of motion of hip joint
Time Frame: Day 1 and Day 42
Secondary Outcomes
- Reduction in time to climb stairs.(An increase in distance covered in 6 minutes walk on plain surface)
Investigators
Mohd Faisal Khan
Jamia Hamdard