A CLINICAL STUDY TO EVALUATE THE EFFECT OF RAKTAMOKSHANA WITH MODIFIED SHRUNGA YANTRA ( CUPPING ) IN MANAGEMENT OF VISHWACHI W.S.R TO CERVICAL SPONDYLOSIS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- pain reduction and other symptoms of vishwachi ( cervical spondylosis)
Study Overview
Brief Summary
Title: A Clinical Study to Evaluate the Effect of Raktamokshana with Modified Shrunga Yantra (Cupping) in the Management of Vishwachi with Special Reference to Cervical Spondylosis
Candidate: Dr. Rahul Suresh Aari 1st Year M.S. (Ayu) PG Scholar, Department of PG Studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi, Karnataka.
Guide Dr. Rajneesh V. Giri, M.S. (Ayu), PhD, HOD and Professor, Department of PG Studies in Shalya Tantra.
Co-Guide Dr. Subhas Bhakta, M.S. (Ayu), Assistant Professor, Department of PG Studies in Shalya Tantra.
Institution Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karnataka.
Submission Date October 16, 2023
Objective To evaluate the efficacy of Raktamokshana using modified Shrunga Yantra (cupping therapy) in managing Vishwachi, correlated with cervical spondylosis.
Background and Need for Study
Cervical Spondylosis A degenerative condition affecting the cervical spine, common from the third decade, peaking in the fifth and sixth decades. Symptoms include chronic neck pain, stiffness, radiating pain, and paraesthesia, resembling Vishwachi, a Vata-related disorder in Ayurveda affecting the neck and upper limbs.
Vishwachi Characterized by symptoms like pain (Ruk), pricking pain (Toda), stiffness (Stambha), and weakness in the upper limbs, caused by vitiated Vata and Rakta doshas.
Current Treatments Conventional treatments include physiotherapy, analgesics, steroids, and surgery, which may have side effects like musculoskeletal and metabolic issues. Raktamokshana, a para surgical Ayurvedic procedure, is indicated for Vishwachi due to its minimal complications and cost-effectiveness.
Literature Review
Vishwachi is described in Ayurvedic texts as a Vata disorder affecting the neck, shoulder, and arms, correlating with cervical spondylosis, which involves degenerative changes in cervical vertebrae (C5C6, C6C7, C4C5).
Raktamokshana by Siravyadha is a recommended treatment for Vishwachi in classical texts.
Previous studies showed that Shringavacharana (cupping) provided steady symptom relief, while Agnikarma offered quicker but less sustained results.
Hypothesis
Null Hypothesis Raktamokshana with modified Shrunga Yantra has no significant effect on Vishwachi.
Alternative Hypothesis Raktamokshana with modified Shrunga Yantra has a significant effect on Vishwachi.
Methodology
Study Design Open-label clinical study with pre and post test design.
Sample Size Minimum of 30 patients aged 25 to 70 years diagnosed with Vishwachi cervical spondylosis from SDM Ayurveda Hospital, Udupi.
Diagnostic Criteria Neck pain, stiffness, radiating pain, paraesthesia, positive Spurlings test, neck compression extension tests, Lhermittes sign, and Xray findings.
Inclusion Criteria Patients with Vishwachi symptoms, aged 25 to 70 years, with written consent.
Exclusion Criteria Patients contraindicated for Raktamokshana, with uncontrolled diabetes (HbA1c more than7 ), hypertension (BP greater than or equal to 140 by 90 mmHg), spinal fractures, or conditions like ankylosing spondylitis, tuberculosis, or neoplasms.
Intervention: Two sittings of Raktamokshana using modified Shrunga Yantra (cupping) with 7 day intervals. Procedure involves marking tender points, making superficial pricks with a sterile needle, applying cups to create a vacuum, and cleaning the site post-procedure. Patients advised to avoid strenuous activities and certain foods for a day.
Study Duration 14 days with observations on days 1, 7, and 14, and follow up on day 14.
Assessment Criteria
Subjective Stiffness, Visual Analog Scale (VAS) for pain.
Objective Northwick Park Neck Pain Questionnaire, cervical range of motion (goniometer), Douleur Neuropathique 4 (DN4) for neuropathic pain.
Statistical Analysis Paired T test for parametric data and Wilcoxon signed rank test for nonparametric data.
Investigations Hb, TC, DC, ESR, CT, BT, HbA1c, HBsAg, HIV, Xray (AP lateral cervical spine), and CT spine if needed.
Ethical Considerations Ethical clearance obtained from the institutions ethical committee. The study involves human subjects, with no animal experiments.
References Includes Ayurvedic texts (Susrutha Samhita, Charaka Samhita), modern medical texts (example Harrisons Principles of Internal Medicine), and prior theses on related topics.
This study aims to provide evidence for the efficacy of Raktamokshana with modified Shrunga Yantra as a safe and effective treatment for Vishwachi cervical spondylosis, potentially offering an alternative to conventional treatments with fewer side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with features of vishwachi like radiating pain from prishta(back), skandha(shoulder), bahu(arm), karpura(elbow), extending up to hasta talam(palm) and pratyanguli( fingers) stambha(stiffness), toda(pricking pain) of neck, tingling, numbness and difficulty in movements of hands or patients with positive spurlings test or patients with positive neck flexion and extention compression test or patients with positive neck distraction test or patients with positive lhermittes sign.
Exclusion Criteria
- •Patients contraindicated for raktamokshana, patients with history of uncontrolled diabetes mellitus( HBA1c level of greater than 7% to greater than 8%) and hypertension( systolic bp greater than or equal to 140mmhg and diastolic bp greater than or equal to 90mmhg) patients with spinal fractures, having associated conditions like ankylosing spondylitis, spondylolisthesis.
- •Patients with spinal tuberculosis, neoplasms in and around the spine or cervical region, patients with rheumatoid arthritis and patients with clinical presentation other than cervical spondylosis.
Outcomes
Primary Outcomes
pain reduction and other symptoms of vishwachi ( cervical spondylosis)
Time Frame: first day post procedure
Secondary Outcomes
- reduction in pain and other symptoms of vishwachi (cervical spondylosis)(seventh day and fourteenth day post procedure)
Investigators
Dr Rahul Aari
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre