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CTRI Number  CTRI/2025/10/095568 [Registered on: 03/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
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   A study comparing shoulder treatments (hydrodistension, nerve block, and their combination) to improve pain and movement in patients with frozen shoulder (stage II and III) 
Scientific Title of Study   A Three-arm Randomized Control Trial Comparing Efficacy of Hydrodistension Hydrodistension With Suprascapular Nerve Block And Suprascapular Nerve Block Alone In Patients With Stage II and III (Hannafin And Chaia Staging) Adhesive Capsulitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abdu Raheem KK 
Designation  Junior resident 
Affiliation  AIIMS Bibinagar 
Address  Department of orthopaedics, Aiims Bibinagar, Yadadri district, Telangana

Hyderabad
TELANGANA
508126
India 
Phone  9061344072  
Fax    
Email  raheemabdu693@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Y. Ranjith Kumar 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of orthopaedics, Aiims Bibinagar, Yadadri district, Telangana

Hyderabad
TELANGANA
508126
India 
Phone  9000536536  
Fax    
Email  drranjithkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abdu Raheem KK 
Designation  Junior resident 
Affiliation  AIIMS Bibinagar 
Address  Department of orthopaedics, Aiims Bibinagar, Yadadri district, Telangana

Hyderabad
TELANGANA
508126
India 
Phone  9061344072  
Fax    
Email  raheemabdu693@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS 
Address  BIBINAGAR, HYDERABAD, TELANGANA, PIN:508126 
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 Abdu Raheem KK  AIIMS Bibinagar  Department of orthopaedics, Aiims Bibinagar, Hyderabad, Yadadri district. PIN:508126
Hyderabad
TELANGANA 		 9061344072

raheemabdu693@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combined hydrodistension and suprascapular nerve block  Hydrodistension: Under aseptic preparation, the joint injection will be performed using a posterolateral approach with a 23-gauge needle under ultrasound guidance. After needle placement confirmation, 2% lidocaine (4 mL), triamcinolone (40 mg), and normal saline (15 mL), for a total 20 mL fluid volume, will be injected under ultrasound guidance. Suprascapular nerve block is given at the spinoglenoid notch with 4 mL bupivacaine (0.5%), 4 mL lidocaine (2%), and 20 mg triamcinolone under ultrasound guidance. Dexamethasone, is added to standard anaesthetic drugs to prolong the effect of anaesthesia.  
Comparator Agent  Hydrodistension  Under aseptic preparation, the joint injection will be performed using a posterolateral approach with a 23-gauge needle under ultrasound guidance. After needle placement confirmation, 2% lidocaine (4 mL), triamcinolone (40 mg), and normal saline (15 mL), for a total 20 mL fluid volume, will be injected under ultrasound guidance. 
Intervention  Suprascapular nerve block  SSNB (suprascapular nerve block) is given at the spinoglenoid notch with 4 mL bupivacaine (0.5%), 4 mL lidocaine (2%), and 20 mg triamcinolone under ultrasound guidance. Dexamethasone, is added to standard anaesthetic drugs to prolong the effect of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All adult patients who have given consent for the study and diagnosed to
have primary Adhesive capsulitis based on Zuckerman`s criteria and are in Stage II & III (Hannafin
and Chiaia classification) of Adhesive Capsulitis are included in the study.
Zuckerman’s diagnostic criteria, for diagnosis of adhesive capsulitis consist of:
a) Sudden onset
b) Range of motion (ROM) during the active and passive elevation of the shoulder less than 100
c) ROM limitation in external rotation less than 50 % on the contralateral side
d) Shoulder pain during night
e) Normal radiographical findings 
 
ExclusionCriteria 
Details  1)Patients who refuse the intervention.
2)who have a history of shoulder surgery.
3)breast surgery.
4)fracture around the shoulder and upper extremities.
5)have a cerebrovascular disease and cervical
radiculopathy.
6)uncontrolled diabetes mellitus.
7) who underwent shoulder surgery during study. 8)any other shoulder pathology.
9)contraindicated for SSNB or allergic
to local anaesthetic drugs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in range of motion  2nd day, 2nd week, 4th week, 8th week, 12th week post
intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome of Pain  2nd day, 2nd week, 4th week, 8th week, 12th week post
intervention 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   26/10/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 26-07-2027 and end date provided 26-10-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Adhesive capsulitis is a common shoulder disorder characterized by pain and restricted range of motion. Various treatments exist, but the most effective approach remains uncertain. This randomized controlled trial will compare the functional outcome of three treatment methods for Hannafin and Chiaia stage II and III adhesive capsulitis of the shoulder. The study will be conducted in the Department of Orthopaedics at AIIMS Bibinagar over a period of two years from June 2025 to June 2027. A total of 54 adult patients meeting Zuckerman diagnostic criteria will be enrolled and randomly allocated into three equal groups. Group one will receive ultrasound guided hydrodistension of the glenohumeral joint with corticosteroid and normal saline. Group two will receive hydrodistension combined with suprascapular nerve block, and group three will receive suprascapular nerve block alone. All participants will perform a supervised shoulder exercise program after the intervention. Pain will be measured using the Visual Analogue Scale, shoulder function by the Shoulder Pain and Disability Index and Quick DASH scores, and range of motion by goniometer at baseline and at day 2, week 2, week 4, week 8, and week 12. Data will be analyzed using appropriate statistical tests with a significance level of 0.05. The trial aims to identify which treatment provides the best pain relief, range of motion, and functional recovery in adhesive capsulitis. 
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