| CTRI Number |
CTRI/2025/07/091686 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of shoulder pain with multiple ayurveda procedures |
|
Scientific Title of Study
|
Efficacy of Multi modal approach in the management of Chronic Rotator Cuff injury A Randomized controlled trial |
| 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 Santosh G Sharma |
| Designation |
PG Scholar |
| Affiliation |
KAHER shri B M K Ayurveda Mahavidyalaya |
| Address |
Room number 8 Department of Shalyatantra KAHER shri B M K Ayurveda Mahavidyalaya Belagavi
Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9665107219 |
| Fax |
|
| Email |
sharmasantosh09272@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Associate Professor |
| Affiliation |
KAHER shri B M K Ayurveda Mahavidyalaya |
| Address |
Room number 8 Department of Shalyatantra KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Associate Professor |
| Affiliation |
KAHER shri B M K Ayurveda Mahavidyalaya |
| Address |
Room number 8 Department of Shalyatantra KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India
Pin code 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Santosh G Sharma |
| Address |
PG Scholar Department of Shalyatantra KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India
Pin code 590003 |
| Type of Sponsor |
Other [self] |
|
|
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 Santosh G Sharma |
KAHER shri B M K Ayurveda Mahavidyalaya |
Room number 8
Department of Shalyatantra
Division General Shalya OPD Belgaum KARNATAKA |
09665107219
sharmasantosh09272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M751||Rotator cuff tear or rupture, notspecified as traumatic. Ayurveda Condition: AMSA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Multimodal therapy | It will be recommended to take 500 mg tablets of oral acetaminophen twice a day for 14 days Transcutaneous electrical nerve stimulation and Hot moist pack therapy for 7 days and exercise therapy will be administered to the participants for 14 days TENS treatment will be administered continuously for 20 minutes at a strength of 40 μSN and 100 Hz while hot pack therapy will be used for 20 minutes Rotator Cuff Exercises Stretching Exercises and Postural and Mobility Exercises such as Resisted internal and external rotation Pectoralis minor stretch Corner stretch and Thoracic extension over towel will be performed ten repetitions a day for a period of 14 days | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: SU SU 12 chapter 10 shloka, Procedure details: Agnikarma with Panchaloha shalaka will be done on day 1 and day 7
Yoga asanas or yoga postures will be carried out for 30 minutes once daily for 14 days
) (1) Medicine Name: Trayodashang Guggulu, Reference: Bhaishajya Ratnavali Vatvyadhi Adhikar chapter 98 verse 101, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 14 Days(2) Medicine Name: Murivenna taila, Reference: the pharmacopoeia of government ayurveda college tiruvanthapuram , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Shoulder pain for minimum 3 months elicited in the anterolateral shoulder region
2 Resting pain at 2 out of 10 maximum on verbal NPRS
3 At least 3 out of 5 provocative tests positive that are Neer test Hawkins Kennedy test Jobe test Painful arc between 60° and 120° and external rotation resistance test
4 Yogya for Agnikarma
|
|
| ExclusionCriteria |
| Details |
1 Glenohumeral osteoarthritis or other inflammatory arthritis
2 Fracture or dislocation of shoulder
3 Previous cervical or shoulder surgery
4 Osteoporosis
5 Neurological disorders like Alzheimers Disease Bells Palsy Epilepsy and Seizures
6 Tumour
7 Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Numeric pain rating scale
2 Visual analog scale
3 Muscle strength by hand held dynamometer or traction dynamometer
4 Range of motion by goniometry
|
Day 0 Day 7 Day 14 Day 21 Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Shoulder pain and disability index
2 Eq5d quality of life index questionnaire |
Day 0 Day 7 Day 14 Day 21 Day 30 |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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
|
Rotator cuff
injuries (RCI) are common orthopaedic problem, prevalence of 20% in the general
population which increases with age. While 50% of injuries are degenerative and
occur in patients over 80, a large subset of injuries occurs in the athletic
population. Athletes at particular risk for RCI include throwing athletes,
overhead athletes, and those in contact sports. The best available evidence is
specific to baseball throwers; however, clinicians should keep in mind the
forced overhead mechanism required in tennis, golf, basketball, volleyball,
track & field (throwers), lacrosse, and swimming athletes who experience
significant and prolonged stress on the shoulder over the course of their
athletic careers. Though a younger, athletic cohort in tennis and baseball are
primarily covered in this review, recreational and master overhead athletes may
present with rotator cuff pathology as well. These injuries can significantly impair shoulder
function, leading to pain, weakness, and restricted range of motion (ROM). Most rotator cuff injuries may be treated conservatively by using regimens of
nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and
functional rehabilitation therapy. For patients who cannot
tolerate NSAIDs, acetaminophen serves as a viable alternative. The choice
between surgical and non-surgical management is influenced by several factors,
such as location of injury, the patient’s age, activity level, and
comorbidities. Despite its benefits, arthroscopic repair has some risks. Common
complications include re-tear, infection, stiffness, and nerve injuy. In Ayurveda,
it can be correlated with Amsa sandhi marmaghata. Amsa marma is a
snayu gata marma, measuring half angula and injury leads to loss
of function in arms. Bhagna chikitsa and vatvyadhi chikitsa
principles should be incorporated during the treatment of Marmaghata. Agnikarma is indicated for pain management in the diseases of Sira
Snayuagata vata. Research have showed that usage of oral
medications is effective in the pain management of marmaghata, among
them Trayodashanga guggulu and Murivenna taila are proved to have efficacy in the musculoskeletal pain management. Multi Modal
approach is the need of the hour and it provides improvements in pain and
function in patients with chronic pain compared with usual care.Yoga
(Asana) is a non-invasive modality commonly used in the rehabilitation of
shoulder injuries which improves muscle flexibility by improving the natural alignment
of joints. A special Multi Modal treatment plan is planned by
incorporating Ayurveda (Agnikarma, oral medicine like Trayodashanga
guggulu and local application of Murivenna taila) and yoga (Asana)
to manage the rotator cuff injury. Hence
with this objective the study will be undertaken to evaluate the efficacy of Multi
Modal approach in the management of rotator cuff injury. |