| CTRI Number |
CTRI/2025/03/082710 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sujok Acupuncture in Frozen Shoulder - A Randomized Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Sujok Acupuncture on Adhesive Capsulitis - A Randomized Control trail. |
| 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 Beula S |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Scineces |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Science, Division III, Faculty Block, Room No. 2, Kamaraja nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9632738883 |
| Fax |
|
| Email |
beulasekar25@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Geethanjali |
| Designation |
Assistant Medical Officer |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Science, Division III, Faculty Block, Room No. 2, Kamaraja nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Geethanjali |
| Designation |
Assistant Medical Officer |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Science, Division III, Faculty Block, Room No. 2, Kamaraja nagar, Chengalpattu
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 Hospital, Department of Acupuncture and Energy Medicine, Kamaraj Nagar, Chengalpattu, Tamil Nadu. PIN - 603001 |
|
|
Primary Sponsor
|
| Name |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Science, Department of Acupuncture and Energy Medicine, Division III, Faculty Block, Room No. 2, Kamaraja nagar, Chengalpattu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Beula S |
International Institute of Yoga and Naturopathy Medical Sciences Hospital |
184/4 International Institute of Yoga and Naturopathy Medical Science,Department of Acupuncture and Energy Medicine, Division III, Room No. 2, Kamaraja nagar, Chengalpattu Kancheepuram TAMIL NADU |
9632738883
beulasekar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee International Institute of Yoga and Naturopathy Medical Sciences Chengalpattu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The sterile needles will be inserted at placebo points using sham acupuncture technique for 30 minutes once a day for five days a week with a follow up period of 3 weeks. |
| Intervention |
Sujok Acupuncture Intervention |
The sterile needles will be inserted in Palm for 30 minutes once a day for five days a week with a follow up period of 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 30 to 60.
Had a pain in past 3 to 6 months duration.
The willingness of participants to participate.
Pain present during passive range of motion.
Interscapular scratch test is positive.
Pain at night and inability to lie on affected side
|
|
| ExclusionCriteria |
| Details |
Open wounds at shoulder region
Sub-acromian bursitis
Rotator cuff tendinopathy or tear
Fracture
Gleno-humoral osteoarthritis
No treatment received in last 4weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale
Range of Movement |
Baseline, 15 days after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder Pain and Disability Index |
Baseline, 15 days after treatment |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" 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 - 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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form 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 [beulasekar25@gmail.com].
- For how long will this data be available start date provided 31-05-2026 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to explore the effects of selective Sujok acupuncture points in patients with adhesive capsulitis, a condition that causes shoulder pain and stiffness. The study’s primary focus is to assess how Sujok acupuncture influences the range of motion (ROM) and pain levels in these patients, as well as to evaluate its impact on functional shoulder activities. A randomized controlled trial (RCT) design will be employed, with participants divided into a study group receiving Sujok acupuncture and a control group undergoing sham acupuncture. The study is set to involve 60 participants aged 30-60 who have experienced shoulder pain for 3 to 6 months. Participants will undergo assessments before and after the intervention (at days 1 and 15) using various outcome measures including the Visual Analog Scale (VAS) for pain, Shoulder Pain and Disability Index (SPADI) for functional limitations, and goniometer measurements for ROM. The study group will receive needling at specific Sujok points on the palm, while the control group will receive sham needling at non-active points. Ethical considerations, such as informed consent and Institutional Ethics Committee clearance, will be followed, and the study will use randomized blinding to ensure objective results. Data will be analyzed using appropriate statistical methods to compare the effects of Sujok acupuncture with placebo treatment. This research aims to provide insight into whether Sujok acupuncture is a beneficial, low-cost alternative treatment for managing adhesive capsulitis, potentially offering a quicker, simpler method for pain relief and improving shoulder function. |