| CTRI Number |
CTRI/2026/01/101008 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of pragmatic set of intervention in patient with frozen shoulder |
|
Scientific Title of Study
|
Effectiveness of a Pragmatic set of Intervention on Capsular Tightness, Range of Motion, pain and Quality of Life in patient of Frozen Shoulder: A Simple 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 |
Kavya Mehta |
| Designation |
Post Graduate student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot 360020, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
7359341780 |
| Fax |
|
| Email |
kmehta299@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupa Tank |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot 360020, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9998810063 |
| Fax |
|
| Email |
krupa.tank@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kavya Mehta |
| Designation |
Post Graduate student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot 360020, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
7359341780 |
| Fax |
|
| Email |
kmehta299@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University
Rajkot-Bhavnagar Highway Kasturbadham Rajkot Gujarat - 360 020 India
|
|
|
Primary Sponsor
|
| Name |
Sunshine Physiotherapy Clinic |
| Address |
Satya Sai Main Road, Opposite Satya Sai Heart Hospital, behind Atmiya Collage, Gurudev Park, Narayan Nagar, Rajkot, Gujrat
360005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aastha Super Specialty Hospital |
2nd floor, Kamdhenu Complex, opposite New Swaminarayan Temple,swamiji Sheri,Mandvi,Gujrat
370465 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kavya Mehta |
School of physiotherapy, RK university |
Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturba Dham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat
360020 India
Rajkot
GUJARAT |
7359341780
kmehta299@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commite |
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 |
| Comparator Agent |
Conventional Physiotherapy
|
joint mobilization, active assisted exercise, wand exercises, ladder will be given to the Patient for 4 weeks followed by five days per week |
| Intervention |
Pragmatic set of intervention |
Pragmatic set of the intervention in patients with adhesive capsulitis will be given for 4 weeks followed by five days per week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals diagnosed with adhesive capsulitis (frozen shoulder) based on clinical examination (painful restriction of both active and passive shoulder movements, especially external rotation.
2) A patient who fall in grade 1 and grade 2 of the shoulder mobility test of functional movement screening.
3) Age between 40 to 70 years.
4) Limitation in range of motion abduction or internal rotation or external rotation or reaching up behind the back or reaching behind down the neck are only one of the limitations in comparison with the unaffected joint.
|
|
| ExclusionCriteria |
| Details |
1) Patient with shoulder ligamentous instability 2) Functional movement Screening score 0 or 3.
3) Cancerous growth around the shoulder girdle
4) Rheumatoid arthritis patients.
5) The patient has a recent fracture of less than the 6 week duration or shoulder dislocation.
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional reach test |
First day and end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
First day and end of 4th week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/01/2026 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of a pragmatic posterior set of interventions on capsular tightness, range of motion, pain, and quality of life in diabetic patients with frozen shoulder (adhesive capsulitis). A total of 50 participants meeting the inclusion criteria will be recruited and randomly allocated into two groups: an experimental group (Group A) receiving a pragmatic set of interventions along with conventional physiotherapy, and a control group (Group B) receiving conventional physiotherapy alone. Both groups will undergo a 4-week intervention program, consisting of five treatment sessions per week. Outcome measures, including capsular tightness, pain, range of motion, and quality of life, will be assessed before and after the intervention using the Functional Reach Test, NPRS, and Universal Goniometer. The study aims to determine whether the addition of a pragmatic intervention provides superior clinical outcomes compared to conventional physiotherapy alone. |