| CTRI Number |
CTRI/2025/12/098680 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating whether Master Tung Acupuncture can reduce pain and stiffness in Frozen Shoulder |
|
Scientific Title of Study
|
Effectiveness of Master Tungs Acupuncture points in managing
Adhesive Capsulitis- 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 Kalaiselvan G |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9498421402 |
| Fax |
|
| Email |
drekalaivanmail@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geethanjali S |
| Designation |
Head of Department(i/c) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geethanjali S |
| Designation |
Head of Department(i/c) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr Kalaiselvan G |
| Address |
International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam TN-603001 |
| Type of Sponsor |
Government medical college |
|
|
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 Kalaiselvan G |
International Institute of Yoga and Naturopathy Medical Sciences |
Department of Naturopathy and Yoga – Division of Branch III (Acupuncture and Energy Medicine), International Institute of Yoga and Naturopathy Medical Sciences 184/4 Kamarajar Nagar, Vallam Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU |
9498421402
drekalaivanmail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee International Institute of Yoga and Naturpathy Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Master Tungs Acupuncture |
The intervention involves the use of sterile, single-use acupuncture needles inserted at specific Master Tung acupuncture points—77.18, 77.19, and 77.21. These points are selected based on their traditional indication for shoulder pain and restricted mobility. Each treatment session lasts for 30 minutes, during which the needles remain in place to stimulate the selected points effectively. The procedure will be administered once daily for five days a week, forming a structured weekly treatment schedule. This regimen will be continued throughout the intervention period, followed by a three-week observation phase to monitor carry-over effects and sustained improvements. Needling will be performed exactly at the designated Master Tung locations as shown in the study protocol, ensuring consistency and accuracy across all participants. This standardized approach helps maintain therapeutic reliability and supports the validity of the study outcomes |
| Comparator Agent |
Sham Acupunture |
In the control group, sterile and single-use acupuncture needles will be inserted at placebo points using a standardized sham acupuncture technique. These placebo points are selected to ensure they do not correspond to any recognized therapeutic acupuncture meridians or Master Tung points, thereby minimizing the possibility of producing specific clinical effects. The sham technique involves superficial insertion, with the needle penetrating only the uppermost layers of the skin without eliciting deqi sensation, thus maintaining participant blinding while ensuring minimal physiological stimulation. Each sham treatment session will last for 30 minutes, administered once daily for five days per week, matching the frequency and duration of the intervention group to maintain procedural consistency. The treatment period will be followed by a three-week observation phase to monitor any delayed responses or natural improvements. Strict adherence to the sham protocol will be maintained to ensure methodological rigor and to allow clear comparison between true acupuncture effects and placebo responses. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
People between the ages of 30 and 60 who have had shoulder pain for the past 3 to 6 months can take part in this study. Participants should be willing to join and should experience pain during both active and passive shoulder movements. They must also have a positive interscapular scratch test and report night-time pain with difficulty lying on the affected side. |
|
| ExclusionCriteria |
| Details |
Participants with open wounds, sub-acromial bursitis, rotator cuff tendinopathy or tears, fractures or dislocations of the shoulder joint, or gleno-humeral osteoarthritis will not be included in the study. Individuals who have received acupuncture treatment within the last one week will also be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS, SPADI |
3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A universal goniometer will be used to measure shoulder range of motion in participants with adhesive capsulitis by positioning the fulcrum at specific anatomical landmarks for each movement. Flexion will be measured by aligning the fulcrum with the lateral aspect of the greater tubercle, extension using the same axis, & abduction by placing the fulcrum at the anterior acromion. External rotation will be measured with the shoulder abducted to 90 degrees & the fulcrum positioned over the olecranon, while internal rotation will be assessed in the same position. Throughout the procedure, the scapula will be stabilised to prevent compensatory movements, & both active & passive ranges of motion will be recorded. All measurements will be repeated for accuracy. Participants in both groups will be assessed on Day 1 & Day 15 |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2026 |
| 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="2"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drekalaivanmail@gmail.com].
- For how long will this data be available start date provided 15-10-2027 and end date provided 31-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial evaluates the effectiveness of Master Tung’s acupuncture points in managing adhesive capsulitis (frozen shoulder). Adhesive capsulitis is a painful condition common in adults aged 30–60, often associated with diabetes and characterized by progressive pain, stiffness, and reduced shoulder mobility. Conventional treatments include physiotherapy, NSAIDs, steroid injections, nerve blocks, and surgical interventions, but each has limitations. Acupuncture—especially Master Tung’s system, which uses distal, zone-based points—has shown promising results in pain relief and functional improvement, yet high-quality trials for adhesive capsulitis are limited.
The study adopts a randomized controlled design with 90 participants divided into two equal groups. The study group receives Master Tung’s acupuncture at points 77.18, 77.19, and 77.21 for 30 minutes, five days a week, followed by a three-week observation period. The control group receives sham acupuncture at placebo points using a superficial, non-therapeutic technique of equal duration and frequency. Assessments are conducted on Day 1 and Day 15.
Primary outcomes include pain intensity measured using the Visual Analogue Scale (VAS) and functional disability assessed through the Shoulder Pain and Disability Index (SPADI). Secondary outcomes include changes in shoulder range of motion (ROM) measured with a universal goniometer for flexion, extension, abduction, internal rotation, and external rotation. Ethical clearance, informed consent, randomization, and participant confidentiality are ensured throughout the study. Data will be analyzed using appropriate statistical methods via SPSS.
Overall, this study aims to determine whether Master Tung’s acupuncture can significantly reduce pain and disability and improve shoulder mobility compared with sham acupuncture in patients with adhesive capsulitis. |