| CTRI Number |
CTRI/2025/12/099791 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two physiotherapy methods for Shoulder Pain in Diabetic Patients |
|
Scientific Title of Study
|
Effectiveness of Mulligan and Maitland Technique on Pain, Inferior glenohumeral ligament thickness and Shoulder Functional activities among Type II Diabetic subjects with Adhesive Capsulitis: A Randomized Clinical 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 |
Prof Saravanan V S |
| Designation |
Professor and Principal |
| Affiliation |
Mohamed Sathak A J College of Physiotherapy |
| Address |
Department of Physiotherapy Room Number 016
Fourth Floor
Mohamed Sathak A J College of Physiotherapy
No 144 Nungambakkam High Road Nungambakkam
Chennai
Tamil Nadu
India
Chennai
TAMIL NADU
600034
India |
| Phone |
8778747895 |
| Fax |
|
| Email |
saravananreseach25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Akash B |
| Designation |
M Sc Public Health |
| Affiliation |
The Tamil Nadu Dr M G R Medical University |
| Address |
Department of Epidemiology
The Tamil Nadu Dr M G R Medical University No 69 Anna Salai Guindy Chennai Tamil Nadu India
Chennai
Tamil Nadu
India
Chennai
TAMIL NADU
600 032
India |
| Phone |
9043520998 |
| Fax |
|
| Email |
akashdon9043@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Dharani L |
| Designation |
M Sc Public Health |
| Affiliation |
The Tamil Nadu Dr M G R Medical University |
| Address |
Department of Epidemiology
The Tamil Nadu Dr M G R Medical University No 69 Anna Salai Guindy Chennai Tamil Nadu India
Chennai
Tamil Nadu
India
Chennai
TAMIL NADU
600 032
India |
| Phone |
9150738428 |
| Fax |
|
| Email |
dharaniloganathan1206@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Room Number 016 Fourth Floor Mohamed Sathak A J College of Physiotherapy No 144 Nungambakkam High Road Nungambakkam Chennai Tamil Nadu India
Chennai
TAMIL NADU
600034
India |
|
|
Primary Sponsor
|
| Name |
Prof Saravanan V S |
| Address |
Professor and Principal
Mohamed Sathak A J College of Physiotherapy
No 144 Nungambakkam High Road Nungambakkam
Chennai Tamil Nadu India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Anugraha Hospital |
Pammal Chennai Tamil Nadu India |
| Dhanam Health Care and Diabetic Centre |
No 8 Pozhichalur Main Road Pozhichalur Chennai 600074 Tamil Nadu India |
| Dr Kumars Healthcare Private Limited |
No 35 1st Main Road New Colony Chrompet Chennai 600044 Tamil Nadu India |
| Root Lamp Trust |
L Block 3rd Floor Mahindra Happinest Apartment 5th Cross Street Paruthipattu Avadi Thiruvallur Tamil Nadu 600071 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Saravanan V S |
Mohamed Sathak A J College of Physiotherapy |
Outpatient Department of Physiotherapy
Room Number 019
Third Floor
Mohamed Sathak A J College of Physiotherapy No 144 Nungambakkam High Road Nungambakkam Chennai
Tamil Nadu
India
Chennai
TAMIL NADU |
8778747895
saravananreseach25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| GCU INSTITUTIONAL ETHICAL CLEARANCE |
Approved |
| MSAJ INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gentle range of motion |
Group C Gentle range of motion
Tuesday Thursday and Saturday Morning session 09 30 am to 12 30 pm
Wand Exercises Ball Rolling or Table Top Dusting Wall Window Washing Pendulum Codman Exercises Gear Shift Exercises
3 sets and 5 repetitions |
| Intervention |
Maitland Technique with capsular stretching |
Group B Maitland Technique
Monday Wednesday and Friday Afternoon session 02 30 pm to 05 30 pm
Glenohumeral mobilization
Maitland Technique For Caudal Glide For Anterior Glide For Posterior Glide Capsular Stretching Anterior capsule Posterior capsule Anterior inferior capsule
3 sets and 5 repetitions |
| Intervention |
Mulligan Technique with capsular stretching |
Group A Mulligan Technique
Monday Wednesday and Friday Morning session 09 30 am to 12 30 pm
Mulligan Technique Technique 1 Posterolateral glides with active elevation Technique 2 Movement With Mobilization for Shoulder Flexion Technique 3 Movement With Mobilization for Internal Rotation of Shoulder Technique 4 Movement With Mobilization for Painful Restriction of Shoulder External Rotation Capsular Stretching Anterior capsule Posterior capsule Anterior inferior capsule
3 sets and 5 repetitions |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both Male and Female subjects will be included in the study
Age between 40 to 60 years diagnosed with Type II diabetes mellitus for less than 5 years
Subjects with optimal glycated Haemoglobin control
Subjects with numerical pain rating scale NPRS ranging between 4 to 7 and onset of pain less than 4 weeks
Sub acute stage of adhesive capsulitis with unilateral shoulder involvement
Subjects diagnosed by clinician according to criteria mentioned in clinical practice guidelines for Adhesive Capsulitis
Subjects with adhesive capsulitis shoulder with significantly impaired active and passive range of motion Abduction and External Rotation Test Positive |
|
| ExclusionCriteria |
| Details |
Subjects administered with corticosteroid injection to the affected shoulder in the previous three months
Subjects with congenital or acquired shoulder deformity
Malignancy in and around the shoulder complex
Any Fracture of shoulder complex bones Glenohumeral dislocation Concomitant cervical spine symptoms past shoulder surgery and Rotator cuff pathology
Neurological disorders with shoulder involvement eg Stroke Parkinsons disease
Post coronary artery bypass surgery syndrome post pericardiotomy syndrome Individuals with uncontrolled diabetes
Bilateral Adhesive capsulitis
Type I Diabetes Mellitus
Chronic Adhesive capsulitis
Subjects those who are not willing to participate in the study
Subjects those who are not able to provide consent for participation in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Inferior glenohumeral ligament thickness
Range of Motion
Pain Pressure Threshold |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Functional Activities
Quality of Life |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
03/03/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized parallel group double blinded trial, comparing the effectiveness of mulligan with capsular stretching and maitland with capsular stretching for diabetic patients with adhesive capsulitis for 1 year among 300 patients that will be conducted in physiotherapy out patient department. The primary outcome measures will be inferior glenohumeral ligament thickness, range of motion and pain pressure threshold. The secondary outcomes will be pain, functional activities and quality of life.
|