Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: M501- Cervical disc disorder with radiculopathy Health Condition 3: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy Health Condition 4: M750- Adhesive capsulitis of shoulder
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Individuals with pain from the following musculoskeletal diseases: OA knee, cervical radiculopathy, lumbar radiculopathy, and frozen shoulder. Presence of pain (greater than 3 on the VAS. Patients willing to comply to Marma therapy
Exclusion criteria
Exclusion criteria: Patients with major systemic illness like malignancy, tuberculosis, renal disease, hepatic disease and cardiovascular disease. Patients with severe canal stenosis or cord compression, myelopathy and cauda equina syndrome. Patients with congenital bone or joint pathologies. Signs and symptoms of peripheral neuropathy affecting the limbs other than those explained by L4/L5/C3-T1, or if they had surgical treatment, greater than 1 neurolytic injection, or treatment with corticosteroid injection in the 3 months before randomizationPatients with rotator cuff tear and painful arc syndrome. Pregnant women and lactating mothers. Patients who are already on Ayurvedic management for musculoskeletal diseases. Patients with h/o of peripheral neuropathy or vascular disease. Patients with rotator cuff tear and painful arc syndrome. Pregnant women and lactating mothers. Participants having active liver disease or unexplained persistent elevation of serum transaminases greater than 3 times the upper limit of normal. History or presence of alcohol or substance abuse, including analgesics used as standard of care. Patients with infective and inflammatory joint disorders and pain due to acute or chronic trauma. Presence of any medical or psychological condition, as determined by the Principal Investigator (PI), that could interfere with the participant s ability to comply with study procedures or safely undergo Marma therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in pain scores on Visual Analog Scale (VAS)Timepoint: Time frame: Baseline, week 1, week 2, week 3, week 4, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pain-Related Interference assessed using the Brief Pain Inventory- (Short Form) (BPI-SF)Timepoint: Baseline, week 1, week 2, week 3, week 4, Day 60, 90;Change in quality of life assessed by the 12-Item Short Form Health Survey (SF-12)Timepoint: Baseline and Month 3;Change in Mobility and Flexibility assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-For Osteoarthritis, and Oswestry Disability Index (ODI)- for LBA and through range of movements (ROM)Timepoint: Baseline, 3 months;Duration of Sustained Pain Relief Post-Marma TherapyTimepoint: Post-treatment assessments after each session;Assessment of the tolerability through the reported incidence of treatment-emergent adverse events and serious adverse events and proportion of participants reluctant to continue marma sessionsTimepoint: Baseline to month 3;Treatment Adherence/compliance assessed by self-reported log of participants attendance and participation in marmatherapy sessions, which will be cross-checked against scheduled sessions.Timepoint: Marked at the end of each session as per the prescribed schedule;Change in Patient Global Impression of Change (PGIC) assessed through a PGIC scaleTimepoint: Baseline, Day 30 Day 60, 90;Change in sleep assessed by Sleep Disturbance Short Form 4aTimepoint: Baseline, week 1, week 2, week 3, week 4, Day 60, 90;Change in Analgesic Use, [both oral and topical analgesic use] assessed through a self-reported medication diaryTimepoint: Baseline, Day 30 Day 60, 90 | — |
Countries
India
Contacts
Public ContactDr Pratap Shankar K M
National Ayurveda Research Institute for Panchakarma
Outcome results
None listed