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CTRI Number  CTRI/2024/03/064017 [Registered on: 12/03/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Trigger point stretch dry needling in patient with Adhesive Capsulitis - A randomized control trial 
Scientific Title of Study   Efficacy of myofascial trigger point stretch dry needling in patient with Adhesive Capsulitis - A randomized control 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  Monika sharma 
Designation  Student 
Affiliation  Lovely Professional University 
Address  Block 3, Room no: 213, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara.

Jalandhar
PUNJAB
144001
India 
Phone  9818150975  
Fax    
Email  ms141499@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Varun Kalia PhD 
Designation  Assistant Professor 
Affiliation  Lovely Professional University 
Address  Block 3, Room no: 213, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara.

Jalandhar
PUNJAB
144001
India 
Phone  8360374990  
Fax    
Email  varun.26576@lpu.co.in  
 
Details of Contact Person
Public Query  
Name  Monika sharma 
Designation  Student 
Affiliation  Lovely Professional University 
Address  Block 3, Room no: 213, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara.

Jalandhar
PUNJAB
144001
India 
Phone  9818150975  
Fax    
Email  ms141499@gmail.com  
 
Source of Monetary or Material Support  
Lovely Professional University, Phagwara, Punjab, India. 
 
Primary Sponsor  
Name  Lovely Professional University 
Address  Lovely Professional University, Phagwara, Jalandhar 144001 
Type of Sponsor  Research institution 
 
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 Varun Kalia PhD  Lovely Professional University  Block 3, Room no: 213, Department of Physiotherapy, School of Allied Medical Sciences
Jalandhar
PUNJAB 		 8360374990

varun.26576@lpu.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Lovely professional university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dry Needling with stretch (DNS)  Group 1: Traditional Dry Needling group n 20 subjects will receive MTrP DN for Upper trapezius, supraspinatus, infraspinatus, teres major, deltoid, pectoralis major and teres minor muscles in the neutral position for ten minutes in a session for six alternative days, and conventional physiotherapy treatment for twelve days.  
Comparator Agent  Dry Needling without stretch (DNWS)  Group 2: Myofascial Stretch Dry Needling MSDN group n 20, subjects will receive MTrP-DN for Upper trapezius, supraspinatus, infraspinatus, teres major, deltoid, pectoralis major and teres minor muscles in the stretch position for ten minutes in a session for six alternative days, and conventional physiotherapy treatment for twelve days.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects without Diabetes mellitus. Subjects who are willing to participate and clinically diagnosed with Adhesive capsulitis stage 1 and stage 2. Also, presence of Pain scoring at least 3 out of 10 on Visual analogue scale. 
 
ExclusionCriteria 
Details  Adhesive Capsulitis stage 3 and 4, needle phobia, any skin condition, painkillers before assessment, uncooperative patients, anticoagulation therapy, blood disorders and diabetes mellitus.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Goniometry,
Pressure Pain Threshold,
Visual Analogue Scale 		 Two weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Pain and Disability Index,
Manual Muscle Testing 		 Two weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   18/03/2024 
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="0"
Months="8"
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [ms141499@gmail.com].

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 30-11-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is a single-blinded, two-arm parallel-group, randomized controlled trial to assess the efficacy of myofascial trigger point stretch dry needling in patients with Adhesive Capsulitis (AC). The duration of the study will be 8 months. It will include 40 patients aged between 40-60 years, both male and female who are not having Diabetes mellitus, subjects who are willing to participate, and clinically diagnosed with AC stage 1 and stage 2. Also, the presence of Pain scores at least 3 out of 10 on the Visual analogue scale. Subjects will be excluded from the study, if they have AC stages 3 and 4, needle phobia, skin condition around the shoulder joint, taking painkillers and anticoagulation therapy before assessment, uncooperative behavior of the subjects, blood coagulation disorder, and diabetes mellitus. The primary outcome measures will be the Visual analogue scale, Goniometry, and pressure pain threshold. The secondary outcomes will be Manual Muscle testing and Shoulder pain and disability index. Preassessment will be done by using primary and secondary outcome measures before starting the treatment protocol and post-assessment will be done after 2 weeks of treatment same as pre-assessment.  
 
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