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CTRI Number  CTRI/2022/08/044519 [Registered on: 01/08/2022] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of the analgesic efficacy of steroid injections and nerve blocks in patients with frozen shoulder 
Scientific Title of Study   Comparison of the analgesic efficacy of intra articular steroid injections and combination therapy with supra-scapular nerve block in patients with adhesive capsulitis of the shoulder joint 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yaal Elango 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical Care, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9159186533  
Fax    
Email  yaaelan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adinarayanan S 
Designation  Additional professor 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical Care, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9442396762  
Fax    
Email  adinarayanans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Adinarayanan S 
Designation  Additional professor 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical Care, JIPMER

Mahe
PONDICHERRY
605006
India 
Phone  9442396762  
Fax    
Email  adinarayanans@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Hospital, Gorimedu Puducherry, 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Gorimedu Pondicherry 
Type of Sponsor  Research institution and hospital 
 
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 Yaal Elango  JIPMER  Department of Anaesthesiology and Critical Care JIPMER
Pondicherry
PONDICHERRY 		 9159186533

yaaelan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, JIPMER  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 
Intervention  Combination therapy of supra scapular nerve block and intra articular steroid injection  USG guided supra scapular nerve block with 9.5 ml of 0.5% bupivacaine and intra articular injection of 40 mg (1 ml) triamcinolone and 4.5 ml of 2 % lignocaine. Patient will undergo homogenous physiotherapy protocol. Post intervention SPADI score, VAS score, QuickDASH score, Range of movements, Quality of life and pain medication requirement on day 0,week 2, 6 and 12 will be noted. 
Intervention  Intra-articular steroid injection  USG guided Intra-articular injection of 40 mg (1 ml) triamcinolone and 4.5 ml of 2 % lignocaine. Patient will undergo homogenous physiotherapy protocol. Post intervention SPADI score, VAS score, QuickDASH score, Range of movements, Quality of life and pain medication requirement on day 0,week 2, 6 and 12 will be noted.  
Comparator Agent  Physical therapy   Patient will undergo homogenous physiotherapy protocol. Post intervention SPADI score, VAS score, QuickDASH score, Range of movements, Quality of life and pain medication requirement on day 0,week 2, 6 and 12 will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with diffuse shoulder pain and restriction of movement for more than 3 weeks duration and clinically diagnosed to have adhesive capsulitis 
 
ExclusionCriteria 
Details  1) Cardiopulmonary disease
2) Cervical disc lesions
3) Fractures of ipsilateral limb
4) Calcific tendonitis
5) Bilateral adhesive capsulitis
6) Bleeding disorders
7) Long term steroid therapy
8) Allergy to study drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Shoulder Pain and Disability score (SPADI) among the patients receiving intra-articular steroid injection alone combination of intra-articular steroid injection and supra scapular nerve block and physiotherapy alone.  Pre intervention
post intervention day 0
post intervention week 2
post intervention week 6
post intervention week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of pain using VAS score  Pre intervention
post intervention day 0
post intervention week 2
post intervention week 6
post intervention week 12 
Comparison of Disabilities of the Arm, Shoulder and Hand (Quick DASH) score  Pre intervention
post intervention day 0
post intervention week 2
post intervention week 6
post intervention week 12 
Comparison of Range of movements using Constant shoulder score  Pre intervention
post intervention day 0
post intervention week 2
post intervention week 6
post intervention week 12 
Comparison of Quality of Life using SF-12  Pre intervention
post intervention day 0
post intervention week 2
post intervention week 6
post intervention week 12 
Comparison of need for pain medication requirement using Medication Quantification Scale (MQS 3)  Pre intervention
post intervention day 0
post intervention week 2
post intervention week 6
post intervention week 12 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2022 
Date of Study Completion (India) 31/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Adhesive capsulitis, or “frozen shoulder,” is a condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion. Though considered a self-limited disease, some residual stiffness may remain even after the resolution of capsular inflammation, thereby severely impairing the quality of life of these patients. Thus, early diagnosis and treatment of this condition provides favorable outcome, i.e., symptomatic relief and early improvement in the range of movements (ROM). 

Treatment modalities for adhesive capsulitis include medication, intra-articular steroid injection, nerve blocks, physiotherapy, manipulation under anaesthesia and capsular release. Currently there is no consensus as to the most efficacious treatment.  In our study, we propose to find and compare the effects of intra-articular steroid injections alone and in combination therapy with supra-scapular nerve block in patients with adhesive capsulitis of the shoulder joint.

Few observational studies have studied the efficacy of intra-articular steroid injections and supra-scapular nerve block in adhesive capsulitis. There are no available RCTs, in literature, that have compared the effects of these two modalities singly or in combination therapy among the Indian population.

We propose that use of intra-articular steroid injections, or combination therapy with supra-scapular nerve block together with physical therapy will provide cost effective and quicker outcomes in terms of symptomatic relief and overall improvement in quality of life. The results of this study will help us to choose an ideal intervention technique for patients with adhesive capsulitis.

 
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