| CTRI Number |
CTRI/2025/08/092199 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
In our study we will be including patients with subacromial pain syndrome.We will be giving physiotherapy,corticosteroid injection & combined treatments to see its effects on pain, ROM & kinesiophobia. |
|
Scientific Title of Study
|
Effects of physiotherapy, corticosteroid injection and combined treatments on pain,range of motion and kinesiophobia in patients with subacromial pain syndrome : 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 |
Priyanka Abhay Joshi |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute Of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute Of Physiotherapy,MGM Campus,N-6,Cidco,Chh. Sambhajinagar.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7219104890 |
| Fax |
|
| Email |
priyankaajoshi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Garg |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute Of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute Of Physiotherapy,MGM Campus,N-6,Cidco,Chh. Sambhajinagar.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9027612715 |
| Fax |
|
| Email |
kapilgarg@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kapil Garg |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute Of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute Of Physiotherapy,MGM Campus,N-6,Cidco,Chh. Sambhajinagar.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9027612715 |
| Fax |
|
| Email |
kapilgarg@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy N 6 Cidco Chh Sambhajinagar 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco,Chh.Sambhajinagar, 431003,Maharashtra,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Priyanka Abhay Joshi |
MGM Medical College & Hospital |
OPD no.1,Musculoskeletal Physiotherapy Department,Ground floor,MGM Institute of Physiotherapy,MGM Campus,N-6,Cidco,Chh.Sambhajinagar.
Aurangabad
MAHARASHTRA |
7219104890
priyankaajoshi5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined treatments
(Corticosteroid injection + Physiotherapy) |
Corticosteroid injection + Same protocol of physiotherapy group
(Corticosteroid injection will be administered by the orthopedician from MGM Hospital (only 1 dose of corticosteroid injection will be administered)
2 INTERVENTION Physiotherapy treatment Four weeks protocol = Two weeks supervised exercise program (MGM Physiotherapy Rehabilitation & Fitness Centre) & two weeks of home program This group will consist of total 12 sessions,each exercise session will be of approx 30-45 minutes & will be conducted on alternate days, with a frequency of three sessions per week. OPD exercise will include 1.Eccentric exercises of supraspinatus with pulley & dumbells with 3 sets of 10 reps 2.Internal & external rotation exercises with theraband 3 sets of 10 reps 3.Dynamic hug exercise 3 sets of 10 reps 4.Upper trapezius strech 3 reps with 30 sec of hold Home program will include 1.Posterior shoulder stretch 5 rep.s with 30 sec hold 2.Pectoralis minor stretch 5 rep.s with 30 sec hold 3.Upper trapezius streching exercise 5 rep.s with 30 sec hold 4.Serratus anterior strengthening exercise 3 sets of 10 reps 5.Isometric shoulder external rotation exercise & Isometric shoulder internal rotation exercise - each 3 sets of 10 reps with 5 seconds of hold)
|
| Comparator Agent |
Corticosteroid injection |
Drug Name: Triamcinolone acetate
Dose: 40 mg/mL
Route of Administration: Subacromial injection (posterolateral approach to the acromion)
Frequency: Single injection
(Corticosteroid injection will be administered by the orthopedician from MGM Hospital) |
| Intervention |
Physiotherapy treatment |
Four weeks protocol = Two weeks supervised exercise program (MGM Physiotherapy Rehabilitation & Fitness Centre) & two weeks of home program
This group will consist of total 12 sessions,each exercise session will be of approx 30-45 minutes & will be conducted on alternate days, with a frequency of three sessions per week.
OPD exercise will include
1.Eccentric exercises of supraspinatus with pulley & dumbells with 3 sets of 10 reps
2.Internal & external rotation exercises with theraband 3 sets of 10 reps
3.Dynamic hug exercise 3 sets of 10 reps
4.Upper trapezius strech 3 reps with 30 sec of hold
Home program will include
1.Posterior shoulder stretch 5 rep.s with 30 sec hold
2.Pectoralis minor stretch 5 rep.s with 30 sec hold
3.Upper trapezius streching exercise 5 rep.s with 30 sec hold
4.Serratus anterior strengthening exercise 3 sets of 10 reps
5.Isometric shoulder external rotation exercise & Isometric shoulder internal rotation exercise - each 3 sets of 10 reps with 5 seconds of hold.
|
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed Subacromial pain syndrome patients by orthopaedic surgeon
2.Age between 23-69 years
3.Both Males & females
4.Primary symptoms of moderate or severe unilateral shoulder pain
|
|
| ExclusionCriteria |
| Details |
1.Previous shoulder dislocations
2.Rotator cuff ruptures
3. Scapula /Humeral head/Neck fractures
4.Glenohumeral arthritis or previous shoulder surgery
5.Adhesive capsulitis |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Pre and Post Intervention Period (4 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
Pre and Post Intervention Period (4 week) |
| Kinesiophobia |
Pre and Post Intervention Period (4 week) |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
01/08/2025 |
| 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
|
Patients with subacromial pain syndrome will be selected according to inclusion & exclusion criteria. Purpose of the study will be explained. Written informed consent will be obtained from each participant’s to ensure participation in the study. Demographic details will be taken. Computarized randomization will be done & patients will be divided into three groups. Group A will be corticosteroid injection group.Group B will be Physiotherapy group, & group C will be Corticosteroid injection + Physiotherapy (combined treatments) group. Assessment of pain with the help of NPRS, active range of motion with the help of goniometer & kinesiophobia with the help of Tampa scale for kinesiophobia (TSK-17 Items) will be taken at baseline.Then the respective intervention will be administered to the patients assigned to each group. After 4 weeks the same assessment of pain,range of motion & kinesiophobia will be taken. The data will be recorded on case record form. Data will be collected in excel sheet and will be analyzed using appropriate statistical tests. Group A: Corticosteroid injection group Corticosteroid injection will be administered by the orthopedician from M.G.M. Hospital,Chhatrapati Sambhajinagar. Group B:Physiotherapy group 4 weeks protocol =2 weeks supervised exercise program & 2 weeks of home program Supervised exercise program 1.Eccentric exercises of supraspinatus with pulley & dumbells - 3 sets of 10 rep.s 2.Internal & external rotation exercises with theraband - each 3 sets of 10 rep.s 3.Dynamic hug exercise-3 sets of 10 rep.s 4.Upper trapezius strech 3 rep.s of 30 sec hold Home program 1.Posterior shoulder stretch-5 rep.s with 30 sec hold 2.Pectoralis minor stretch-5 rep.s with 30 sec hold 3.Upper trapezius relaxation exercise 5 times / day 4.Serratus anterior strengthening exercise -3 sets of 10 rep.s 5.Isometric shoulder external rotation exercise & Isometric shoulder internal rotation exercise - each 3 sets of 10 rep.s Group C:Combined treatment (Corticosteroid injection+Physiotherapy) Corticosteroid injection will be administered by orthopaedician + Same protocol of physiotherapy group Outcome measures will be assessed pre & post intervention period.Statistical analysis of the collected data will be done.Conclusion will be established based on the obtained results of the study. |