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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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