| CTRI Number |
CTRI/2025/12/099099 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing surgical and non surgical methods in the treatment of Shoulder impingement |
|
Scientific Title of Study
|
Arthroscopic Subacromial decompression vs conservative management in subacromial impingement- A prospective comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVANAND S |
| Designation |
Post Graduate MS ORTHO |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE, SRM UNIVERSITY |
| Address |
Department of orthopeadics ,SRM medical college and research institute, Chennai Tamil Nadu 603203
Chennai TAMIL NADU 603203 India |
| Phone |
9916117555 |
| Fax |
|
| Email |
ss0644@srm.ist.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devi Prasad |
| Designation |
Professor and chief - Department of orthopeadics |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE , SRM UNIVERSITY |
| Address |
Department of orthopeadics ,SRM medical college and research institute, Chennai Tamil Nadu 603203
Chennai TAMIL NADU 603203 India |
| Phone |
9942508444 |
| Fax |
|
| Email |
devipras@srm.ist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
SHIVANAND S |
| Designation |
Post graduate MS ORTHO |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE, SRM UNIVERSITY |
| Address |
Department of orthopeadics ,SRM medical college and research institute, Chennai Tamil Nadu 603203
Chennai TAMIL NADU 603203 India |
| Phone |
9916117555 |
| Fax |
|
| Email |
ss0644@srm.ist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college and research institute , SRM university |
|
|
Primary Sponsor
|
| Name |
SHIVANAND S |
| Address |
SRM medical college , Potheri , Kattankulathur, Chennai 603203 |
| 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 SHIVANAND S |
SRM medical college and research centre |
Department of orthopeadics , 2ND Floor, G block ,SRM university , SRM medical college ,SRM Nagar Chennai 603203 Chennai TAMIL NADU |
9916117555
ss0644@srm.ist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative management |
Physiotherapy
Analgesics ( depends on the age and other medical conditions of patient)
Steroid injection - kenocort 40mg |
| Intervention |
Subacromial decompression |
Arthroscopic surgical release |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 20 - 60yrs
Clinical and Radiological diagnosis of subacromial impingement.
Neer subacromial impingement classification types 1– 3
Shoulder pain for more than 6 months
|
|
| ExclusionCriteria |
| Details |
Radiographic features suggestive of osteoarthritis
Presence of total rotator cuff rupture
Previous history of surgery to the affected shoulder.
Previous history of fracture to the affected shoulder.
Calcification exceeding 2cm in the rotator cuff tendons.
Any neurological or spinal disorder or uncontrolled Diabetes Mellitus
|
|
|
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 |
Measurement of shoulder function using following scoring systems:
Constant Score
American Shoulder and Elbow Surgeons Score (ASES)
SF-36 questionnaire
|
1MONTH , 3MONTHS , 6MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess which has better functional outomes |
3MONTHS , 6MONTHS |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="8" 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
|
Subacromial impingement syndrome (SAIS) is one of the most common causes of shoulder pain, accounting for nearly 44–65% of shoulder disorders. It occurs due to compression of the rotator cuff tendons beneath the acromion, leading to inflammation and bursitis. While both conservative treatment and arthroscopic subacromial decompression (ASD) are widely used, there is ongoing debate regarding which approach offers superior functional outcomes.
Aim: To compare the functional outcomes of arthroscopic subacromial decompression versus conservative management in patients with subacromial impingement.
Study Design: A prospective randomized controlled trial conducted among adults aged 20–60 years diagnosed clinically and radiologically with subacromial impingement. A total of 60 patients were randomized into two equal groups: one receiving arthroscopic decompression and the other undergoing conservative management (physiotherapy, anti-inflammatory medication, subacromial injections).
Methodology: Block randomization was employed. Functional outcomes were assessed at 3 weeks, 6 weeks, 3 months, and 6 months using the Constant Score, American Shoulder and Elbow Surgeons (ASES) Score, and SF-36 questionnaire. Inclusion and exclusion criteria ensured homogeneity and eliminated confounding factors such as rotator cuff tears, arthritis, or prior shoulder surgery.
Ethical Considerations: Ethical approval was obtained, and informed consent was secured from all participants. Confidentiality and the right to withdraw at any stage were ensured.
Expected Outcomes: It is hypothesized that arthroscopic subacromial decompression will provide better pain relief, improved range of motion, and superior functional recovery compared to conservative management, though both methods have individual merits.
Significance: This study aims to provide evidence-based clarity on the optimal management strategy for subacromial impingement, guiding clinicians toward more effective, patient-centered treatment decisions. |