Comparative clinical trial of Hijamah Bila Shart (Massage cupping) and Hijamah Bi Shart (Wet cupping) in Cervical Spondylosis A randomized, open label, comparative efficacy trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 2)Goniometer reading
Study Overview
Brief Summary
Osteoarthritis is a major health problem due to its prevalence, costs and levels of pain and disability. Risk factors include age, obesity, injury, genetic profiles and females being at more risk .But degenerative changes in cervical spine are higher in males .The unani scholars have mentioned the regimes for the treatment of these diseases .But the effect of these regimens need to be validated. Long term use of NSAIDs and muscle relaxants, the corner stone of OA is not recommended due to its side effects on kidney and liver .Other drugs used in allopathic medicine like Gabapentin cause mental depression , similarly long term use of drug Botulium toxin cause dysphasia, respiratory compromise and sometimes anaphylactic shock.Many studies have validated cupping in cervical spondolysis. Mechanism of action for this effect has been proposed however not much data is there to prove those actions. Also no study have been done to develop proper SOPs for frequency of massage and wet cupping . Hence present study is designed to compare the efficacy of wet cupping with massage cupping, to develop SOPS for frequency of both regimes and to study the sustainability of the efficacy of cupping.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Symptoms of 1)Pain neck radiating in arm 2)Paraesthesia 3)Radiological diagnosis of cervical spondylosis.
Exclusion Criteria
- •Traumatic arthritis 2)Spinal cord disorders 3)Psycho somatic disorders.
Outcomes
Primary Outcomes
2)Goniometer reading
Time Frame: 30 Days
6)Doppler (Previous H/O stroke or other carotid artery diseases)
Time Frame: 30 Days
1)Neck Pain Disability Scale and VAS
Time Frame: 30 Days
3)Kellegran and Lawrence scale
Time Frame: 30 Days
4)MRI (If indicated)
Time Frame: 30 Days
5)Beck Depression Scale
Time Frame: 30 Days
Secondary Outcomes
- 1)Pain Intensity(2)Restricted Movements)
