| CTRI Number |
CTRI/2025/07/091072 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurveda for Chronic Musculoskeletal Pain |
|
Scientific Title of Study
|
Effectiveness of Marma Therapy as adjunct to Ayurveda treatment as usual in Chronic Musculoskeletal Pain Management: A Pragmatic Randomized Controlled study Across Common Musculoskeletal Conditions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratap Shankar K M |
| Designation |
Research Officer (Ay.) |
| Affiliation |
National Ayurveda Research Institute for Panchakarma |
| Address |
Room No. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India |
| Phone |
9744824014 |
| Fax |
|
| Email |
kmpvarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratap Shankar K M |
| Designation |
Research Officer (Ay.) |
| Affiliation |
National Ayurveda Research Institute for Panchakarma |
| Address |
Room No. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
KERALA
679531
India |
| Phone |
9744824014 |
| Fax |
|
| Email |
kmpvarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratap Shankar K M |
| Designation |
Research Officer (Ay.) |
| Affiliation |
National Ayurveda Research Institute for Panchakarma |
| Address |
Room No. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
KERALA
679531
India |
| Phone |
9744824014 |
| Fax |
|
| Email |
kmpvarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Ayurveda Research Institute for Panchakarma (CCRAS), Cheruthuruthy, ThrissurDt, Kerala 679531 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KM Pratap Shankar |
Room No. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma |
Cheruthuruthy
Thrissur
KERALA |
9744824014
kmpvarma@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Ayurveda Research Institute for Panchakarma |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: VATAVYADHIH, (2) ICD-10 Condition:M501||Cervical disc disorder with radiculopathy. Ayurveda Condition: SNAYUGATAVATAH, (3) ICD-10 Condition:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: SNAYUGATAVATAH, (4) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: Ayurveda treatment as usual, Procedure details: Commonly prescribed medicines for osteoarthritis, cervical & lumbar radiculopathy, & frozen shoulder, which include both internal & external treatments (for 3 months))
| | 2 | Comparator Arm | Procedure | - | | (Procedure Reference: Acharya R et al. Marmacikitsa: Basic tenets in Ayurveda and therapeutic approaches. 2nd ed. New Delhi: CCRAS; 2023., Procedure details: Marma therapy along with Ayurveda treatment as usual. Marma therapy will be done as an adjunct with commonly prescribed medicines for osteoarthritis, cervical & lumbar radiculopathy, & frozen shoulder, which include both internal & external treatments (for 3 months))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in pain scores on Visual Analog Scale (VAS) |
Time frame: Baseline, week 1, week 2, week 3, week 4, Day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Pain-Related Interference assessed using the Brief Pain Inventory- (Short Form) (BPI-SF) |
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) |
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) |
Baseline, 3 months |
| Duration of Sustained Pain Relief Post-Marma Therapy |
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 sessions |
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. |
Marked at the end of each session as per the prescribed schedule |
| Change in Patient Global Impression of Change (PGIC) assessed through a PGIC scale |
Baseline, Day 30 Day 60, 90 |
| Change in sleep assessed by Sleep Disturbance – Short Form 4a |
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 diary |
Baseline, Day 30 Day 60, 90 |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Currently, alternative
medicine is most frequently used to treat musculoskeletal pain, and between 59
and 90% of patients utilizing alternative therapies for chronic pain claimed
they were helpful and could serve as an effective adjunctive for the treatment
of chronic pain. More often, it’s understood that patients seek
other alternative therapies following the risk of complication, symptom
reoccurrences on stopping medicines, and long-term usage of analgesics in
conventional medicine. Ayurveda has a branch named marma therapy
has many similarities to acupuncture, osteopathic manipulative care and
chiropractic care targets the correction of dearranged functions at the level
of marma points. These vital points are localized within muscles, joints, bone,
connective tissue, and vascular structures and, when stimulated by applying
appropriate strokes or pressure, are clinically found effective in instant pain
management. It’s therefore necessary to generate evidence on such
non-pharmacological procedures’ impact on chronic pain of musculoskeletal
conditions |