| CTRI Number |
CTRI/2024/11/076200 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| 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
|
The impact of strengthening the middle and lower trapezius muscles on pain, range of motion, and upper extremity functionality in individuals with frozen shoulder. |
|
Scientific Title of Study
|
Effect of Middle and Lower Trapezius Muscle Strengthening on Pain, Range of Motion, and Functionality of the Upper Extremity in Individuals with Frozen Shoulder: A 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 |
Mahyavanshi Riya Balvantbhai |
| Designation |
Pg student |
| Affiliation |
S s agrawal institute of physiotherapy and medical care education |
| Address |
Ortho Outpatient Department Ground Floor at S S Agrawal Institute of Physiotherapy Agrawal College Campus Viranjali Marg Devina Park Navsari
Navsari
Gujarat
396445
India
Navsari
GUJARAT
396445
India |
| Phone |
9638366706 |
| Fax |
|
| Email |
mahyavanshiriya2310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shlesha vaidya |
| Designation |
Principal/assistant professor, PG guide and Phd scholar |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education education navsari |
| Address |
Ortho Outpatient Department Ground Floor at S S Agrawal Institute of Physiotherapy
Agrawal College Campus Viranjali Marg Devina Park Navsari
Navsari
Gujarat
396445
India
Navsari
GUJARAT
396445
India |
| Phone |
9427285250 |
| Fax |
|
| Email |
drsmvaidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shlesha Vaidya |
| Designation |
Principal/assistant professor, PG guide and Phd scholar |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
Ortho Outpatient Department Ground Floor at S S Agrawal Institute of Physiotherapy Agrawal College Campus Viranjali Marg Devina Park Navsari
Navsari
Gujarat
396445
India
Navsari
GUJARAT
396445
India |
| Phone |
9427285250 |
| Fax |
|
| Email |
drsmvaidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ortho Outpatient Department at S S Agrawal Institute of Physiotherapy Agrawal College Campus Navsari |
|
|
Primary Sponsor
|
| Name |
Mahyavanshi riya balvantbhai |
| Address |
At and post mota mahyavanshi mohollo bardoli surat |
| 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 shlesha vaidya |
S S Agrawal institute of physiotherapy and medical care education navsari |
Ortho Department of Physiotherapy Ground Floor Agrawal College Campus Viranjali Marg Devina Park Society Gandevi Road Navsari Gujarat
Navsari
GUJARAT |
09427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S S Agrawal institute ethical committee |
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: M958||Other specified acquired deformities of musculoskeletal system, (3) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CONVENTIONA EXERCISE TRAINING OF FROZEN SHOULDER |
MOBILIZATION AND ACTIVE RANGE OF MOTION OF SHOULDER
5 TIME A WEEK FOR 4 WEEK |
| Comparator Agent |
Middle and lower trapezius muscle strengthening training and conventional exercise training |
Middle and lower trapezius muscle strengthening training and conventional exercise training 5 times a week for 4 weeks |
| Intervention |
Middle and lower trapezius muscle strengthening training and conventional exercise training of frozen shoulder |
Middle and lower trapezius muscle strengthening + conventional exercise (mobilization and active ROM) 5 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and female both
Age: 40-65 years
Frozen shoulder stage: stage 2 (freezing stage)
Capsular pattern positive
Pain 3-5 cm
Unilateral shoulder affection
Primary frozen shoulder
Patient diagnosed with frozen shoulder by orthopedic
|
|
| ExclusionCriteria |
| Details |
History of previous surgery on the shoulder
Shoulder fracture
Glenohumeral or acromioclavicular arthritis
Inflammatory disorders
Bleeding disorders (Ex. Haemophilia)
Presence of severe osteoporosis
Patient who received an intraarticular steroid injection.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TFAST test (Time Function Arm and Shoulder test)
SPADI (Shoulder Pain and Disability Index)
VAS (Visual Analogue Scale) |
BASELINE AND AFTER 4 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT TAKEN |
NOT TAKEN |
|
|
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)
|
05/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
AIM OF THE STUDY To investigate the effect of middle and lower trapezius muscle strengthening on pain, range of motion and functionality of upper extremity in individual with frozen shoulder. |