| CTRI Number |
CTRI/2025/06/088985 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| 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
|
A study on exercises to help people with stiff shoulder move their shoulder better |
|
Scientific Title of Study
|
Comparison of dynamic scapular recognition exercise and post isometric facilitation technique in the upward rotation of scapula and functional ability of shoulder in subjects with adhesive capsulitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARANYADEVI K |
| Designation |
Ph.D Scholar |
| Affiliation |
Saveetha university,Chennai |
| Address |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu
Chennai
TAMIL NADU
602105
India |
| Phone |
9042329975 |
| Fax |
|
| Email |
saranyadeviparthiban@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Anitha A |
| Designation |
Ph.D Scholar |
| Affiliation |
Saveetha university,Chennai |
| Address |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu
Chennai
TAMIL NADU
602105
India |
| Phone |
9176446481 |
| Fax |
|
| Email |
anitha.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Parthiban S |
| Designation |
Professor |
| Affiliation |
Anna university, Chennai |
| Address |
Nandha College of Technology
Erode – Perundurai Main Road,
Vaikkaalmedu,
Erode
Erode
TAMIL NADU
638052
India |
| Phone |
6382494366 |
| Fax |
|
| Email |
parthiba.eee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saranyadevi K |
| Address |
Nandha College of Physiotherapy,
Koorapalayam Pirivu, Pitchandampalayam Post,
Erode – 638 052, Tamil Nadu, India.
|
| Type of Sponsor |
Other [self] |
|
|
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 Loganathan T |
Nandha college of Physiotherapy |
106,Orthopaedic Outpatient Department, Nandha college of Physiotherapy, Koorapalayam pirivu, Pitchandapalayam post, Erode - 638052
Erode
TAMIL NADU |
9843544904
logumpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITTEE NANDHA COLLEGE OF PHYSIOTHERAPY, Koorapalayam Pirivu, Pitchandapalayam Post, Erode - 638052 Tamilnadu. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic scapular recognition exercise |
Proprioceptive exercise 30 min,3 session/week for 2 months |
| Comparator Agent |
Post isometric facilitation technique |
facilitation exercise 30 min,3 sessions/week for two months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject ages ranged from 40 to 60.
Failure of subjects to raise the arm above 100 degrees in the plane of the scapula.
Subjects with pain due to unilateral adhesive capsulitis of the shoulder.
Subjects with restricted Active and Passive shoulder ROM due to unilateral AC.
Subjects with Scapular dyskinesia based on Scapular dyskinesis test.
|
|
| ExclusionCriteria |
| Details |
Subjects with any shoulder condition that precludes engaging in exercise of shoulder joint (Recent surgery, dislocations, subluxations, and fracture around the shoulder, Malignancy, an active infection or active inflammatory condition).
Subjects with shoulder pain due to Hemiplegia, Cervical condition, shoulder impingement syndrome
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Upward rotation of scapula |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional ability of shoulder |
2 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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)
|
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
|
Subjects who satisfy the inclusion criteria will be selected, and assessment will be based on physical examination results and any red flags for exclusion criteria. Sixty subjects will be purposively assigned to the Dynamic Scapula Recognition group and the Post-Isometric group with 30 subjects in each group. The treatment period will be of two months. The exercise regimen for the two groups will be of the same duration (30 minutes, 3 sessions per week for two months). Both the Dynamic Scapula Recognition group and the Post-Isometric group will receive hot packs for 15 minutes and scapular mobilization for 5 minutes. In addition to hot packs and scapular mobilization, the Dynamic Scapula Recognition group will perform dynamic scapula recognition exercises for 15 minutes, and the Post-Isometric Facilitation group will perform the Post-Isometric Facilitation technique for 15 minutes. |