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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [beulasekar25@gmail.com].

  6. 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.

  7. 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.

 
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