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CTRI Number  CTRI/2017/08/009550 [Registered on: 30/08/2017] Trial Registered Prospectively
Last Modified On: 15/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [comparison between one injection method and one nerve block]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effectiveness of suprascapular nerve block versus subacromial steroid injection in shoulder impingement syndrome. 
Scientific Title of Study   A comparative study on efficacy of suprascapular nerve block versus subacromial steroid injection in shoulder impingement syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ambar Konar 
Designation  M.D. Resident 
Affiliation  IPGMER 
Address  Dept. of PMR, IPGMER, 244 AJC Bose Road, Kolkata, West Bengal: 700020

Kolkata
WEST BENGAL
700020
India 
Phone  09433890314  
Fax    
Email  iamthekonarinblue@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajesh Pramanik 
Designation  Associate Professor 
Affiliation  IPGMER 
Address  Dept. of PMR, IPGMER, 244 AJC Bose Road, Kolkata, West Bengal: 700020
Dept. of PMR, IPGMER, 244 AJC Bose Road, Kolkata, West Bengal: 700020
Kolkata
WEST BENGAL
700020
India 
Phone  09432594882  
Fax    
Email  rpramanik2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ambar Konar 
Designation  M.D. Resident 
Affiliation  IPGMER 
Address  Dept. of PMR, IPGMER, 244 AJC Bose Road, Kolkata, West Bengal: 700020
Dept. of PMR, IPGMER, 244 AJC Bose Road, Kolkata, West Bengal: 700020
Kolkata
WEST BENGAL
700020
India 
Phone  09433890314  
Fax    
Email  iamthekonarinblue@gmail.com  
 
Source of Monetary or Material Support  
IPGMER, SSKM Hospital 244 AJC Bose Road, Kolkata, West Bengal: 700020 
 
Primary Sponsor  
Name  IPGMER SSKM Hospital 
Address  244 AJC Bose Road, Kolkata, West Bengal: 700020 
Type of Sponsor  Government medical college 
 
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 
Ambar Konar  IPGMER, SSKM Hospital  Dept. of PMR,School of Physical Medicine, IPGMER, 244, AJC Bose Road, Kolkata, West Bengal 700020
Kolkata
WEST BENGAL 
09433890314

iamthekonarinblue@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M754||Impingement syndrome of shoulder, Patients suffering from shoulder impingement syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  SUBACROMIAL STEROID INJECTION  Single sitting subacromial injection with 40mg Depot methyl prednisolone,1ml 0.25% Bupivacaine and 2ml 2% Lignocaine under strict aseptic condition. 
Intervention  SUPRASCAPULAR NERVE BLOCK  Single sitting suprascapular nerve block at suprascapular notch located by landmark method with 40mg Depot methyl prednisolone,1ml 0.25% Bupivacaine and 2ml 2% Lignocaine under strict aseptic condition. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  (1) Clinically suggestive and USG and/or MRI confirming Neer Stage I & II impingement.
(2) Not sufficiently responding to conservative treatment over 8weeks.
(3) Aged 20 to 60 years.
(4) Pain defined as a score of 5 points or more on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain).
(5) Patient mentally sound enough to communicate and participate in the study and can understand the parameters well. 
 
ExclusionCriteria 
Details  1. USG showing Rotator cuff tear.
2. Bleeding or clotting disorders.
3. Patients refusing intervention or participation.
4. The presence of another obvious associated cause for the pain (i.e., Primary osteoarthritis of glenohumeral joint, fracture, radiculopathy, myofascial pain, central neuropathic pain)
5. Severe motor weakness (muscle power of deltoid less than grade 2 on the manual muscle test).
6. Patients with Post myocardial infarction, Post stroke, Post mastectomy, prolonged immobilization.
7. The presence of an unstable medical condition or a known uncontrolled systemic disease, including cancer, diabetes, rheumatoid arthritis, endocrine disease,
major depression, schizophrenia, & patients with persistent very high level of ESR & CRP.
8. Patients with contraindications of steroid injections i.e. overlying soft tissue sepsis, bacteraemia, anatomic inaccessibility, uncooperative patient, uncontrolled bleeding diathesis etc.
9. Patients who got intra-articular injection in shoulder within last six months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Shoulder Pain And Disability Index (SPADI)  At baseline, Postprocedure 2 weeks, 4 weeks & 12weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Pain (VAS) score (0 to 10)  At baseline, Postprocedure 2 weeks, 4 weeks & 12weeks. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/08/2017 
Date of Study Completion (India) 06/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/02/2018 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Shoulder impingement syndrome is the encroachment of acromion, coraco acromial ligament, coracoid process or acromio-clavicular joint on the rotator cuff muscles. It is the most common musculoskeletal pathology of shoulder joint leading to PM&R OPD visit. Inadequate early treatment leads to progressive stiffness due to pain ultimately leading to adhesive capsulitis. A “pain-less movement-more pain” vicious cycle goes on causing significant difficulty in activities of daily livings (ADL).
Early interruption of the progression of the pathology and symptoms by early diagnosis, short courses of NSAIDs, and a complete stepwise rehabilitation programme for shoulder joint is desired. To hasten the improvement, early intervention or use of modality has a definite positive role. Deep heat modalities like ultrasonic therapy(UST) improves local oedema, helps to get rid of pain producing substances & improves symptoms as well as the pathology.
Intraarticular corticosteroid injection by sub-acromion approach is an age-old treatment procedure for impingement syndrome. But it has shown mixed results mostly in some external impingement variants. It should be avoided in even minute tear in cuff tendons & where joint space decompression is required as some studies as well as textbooks suggested a small chance of progression of partial tear into a complete one after misplaced corticosteroid injection directly in the cuff tendon.
For the last a few years, selective nerve block is been established as one of most feasible and effective intervention in regional painful conditions. Because the degree of neural blockade depends on the drug’s potency and the amount that reaches the nerve fibers, a nerve block can be effective only if it is injected at the the point nearest the nerve. Interestingly most of the afferent supply around the shoulder is by suprascapular nerve, which can be approached from skin, being easily guided by the anatomical landmarks.
So, suprascapular nerve block is effective for managing acute or chronic pain at shoulder. It is a valuable adjunctive therapy in impingement syndrome because it creates a pain-free window period that facilitates therapeutic exercises and restores activities by relieving pain. Among various nerve block techniques, suprascapular nerve block is an effective, feasible, simple, and practical method for the management of shoulder pain following impingement syndrome.
In our study we would try to compare the efficacies of suprascapular nerve block and subacromial steroid injection in patients with shoulder pain due to impingement syndrome. Not many studies have been done to compare the effects of both these accepted methods of treating shoulder pain.
 
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