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CTRI Number  CTRI/2026/01/102155 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 25/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [treatment]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Effect of shoulder joint fluid injection on Recovery in frozen shoulder.A comparison between primary adhesive capsulitis and in post breast cancer patients. 
Scientific Title of Study   Impact of Glenohumeral joint Hydrodilatation on functional recovery in primary versus post breast cancer adhesive capsulitis. A prospective comparative trail. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Safwana Beegum P M  
Designation  Post Graduate Resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Physical Medicine and Rehabilitation Aiims Jodhpur Basni Industrial Area Phase 2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9497561986  
Fax    
Email  beegumsafwana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Gaur 
Designation  Head of the Department and Additional Professor 
Affiliation  All India Institute Of Medical Sciences, Jodhpur 
Address  Department of Physical Medicine and Rehabilitation Aiims Jodhpur Basni Industrial Area Phase 2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  829971153  
Fax    
Email  gaurravi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Gaur 
Designation  Head of the Department and Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Physical Medicine and Rehabilitation Aiims Jodhpur Basni Industrial Area Phase 2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  829971153  
Fax    
Email  gaurravi@gmail.com  
 
Source of Monetary or Material Support  
Aiims Jodhpur Basni Industrial Area Phase 2 Jodhpur Rajasthan India 342005 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Jodhpur 
Address  Basni Industrial Area Phase II Jodhpur Rajasthan India 342005 
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 Safwana Beegum P M  Aiims Jodhpur   Department of Physical Medicine and Rehabilitation Room number 15 Basni Industrial Area Phase 2 Jodhpur
Jodhpur
RAJASTHAN 		 09497561986

beegumsafwana@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: M60-M63||Disorders of muscles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glenohumeral joint Hydrodilatation in primary idiopathic adhesive capsulitis  all participants with idiopathic adhesive capsulitis who have not responded to conservative management for 6 months, undergo ultrasound guided suprascapular nerve block followed by glenohumeral joint hydrodilatation and a structured physical rehabilitation program. The SSNB performed via an inplane technique at the suprascapular or spinoglenoid notch, utilizes 5 mL of local anesthetic with 40 mg triamcinolone to provide quick analgesia and reduce capsular pain prior to hydrodilatation a method proven to shorten symptom duration and improve pain, range of motion and disability in adhesive capsulitis. Hydrodilatation is then administered through the posterior approach with 20 to 30 mL of saline,lignocaine and 40 mg triamcinolone under ultrasound guidance designed to mechanically disrupt capsular adhesion and deliver corticosteroid therapy directly to the joint a technique validated for improving functional outcomes.  
Comparator Agent  Glenohumeral joint Hydrodilatation in secondary adhesive capsulitis due to breast cancer mangemnet  all participants with secondary adhesive capsulitis due to breast cancer mangemnet who have not responded to conservative management for 6 months, undergo ultrasound guided suprascapular nerve block followed by glenohumeral joint hydrodilatation and a structured physical rehabilitation program. The SSNB performed via an inplane technique at the suprascapular or spinoglenoid notch, utilizes 5 mL of local anesthetic with 40 mg triamcinolone to provide quick analgesia and reduce capsular pain prior to hydrodilatation a method proven to shorten symptom duration and improve pain, range of motion and disability in adhesive capsulitis. Hydrodilatation is then administered through the posterior approach with 20 to 30 mL of saline,lignocaine and 40 mg triamcinolone under ultrasound guidance designed to mechanically disrupt capsular adhesion and deliver corticosteroid therapy directly to the joint a technique validated for improving functional outcomes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Age between 18 and 65 years.
2. Clinical diagnosis of adhesive capsulitis with Significant restriction in passive
ROM of the shoulder joint.
3. Shoulder pain VAS score greater than or equal to 5 that exacerbated by movement.
4. Symptoms persisted for at least three months.
5. Diagnosis of breast cancer and completed definitive treatment 
 
ExclusionCriteria 
Details  1.Systemic or structural disorders that could result in limited ROM or pain, such as major trauma, shoulder surgical history, rotator cuff tear, or inflammatory joint disease.
2.Male patients and patients with stage IV breast cancer
3.Neurological conditions affecting the upper limb (e.g., stroke, brachial plexopathy, Radiculopathy).
4.Radiographically significant pathology in shoulder except mild osteopenia
5.Known allergy to local anaesthetics or steroids.
6.Coagulopathy, current anticoagulant therapy, or local skin infection at injection site.
7. Inability to comply with rehabilitation protocol due to physical or cognitive limitation.
8.Active breast cancer under current treatment.
9.Severe cognitive impairment or psychiatric illness interfering with consent or follow-up
10. Refusal to provide informed consent or non-compliance with follow-up schedule
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
evaluate the effectiveness of glenohumeral joint hydrodilatation in improving
SPADI scores in patients with treatment-resistant primary adhesive capsulitis and secondary adhesive
capsulitis following breast cancer treatment, both after failure of conservative management. 		 baseline, 1, 3, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in pain (Visual analogue scale).  baseline, 1, 3, and 6 months 
To assess changes in Range of motion  baseline, 1, 3, and 6 months 
To assess the change in quality of life using SF-12  baseline, 1, 3, and 6 months 
To compare recovery timelines between groups  baseline, 1, 3, and 6 months 
To determine the prevalence and characteristics of ipsilateral shoulder dyskinesia.  baseline, 1, 3, and 6 months 
To compare the effect of postsurgical scar length on change shoulder ROM  baseline, 1, 3, and 6 months 
To evaluate rehabilitation participation post-intervention.
STUDY 		 baseline, 1, 3, and 6 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   10/02/2026 
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="6"
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 - NO
Brief Summary  

This prospective comparative study evaluates the effectiveness of glenohumeral joint hydrodilatation in adults with adhesive capsulitis by comparing patients with primary idiopathic adhesive capsulitis and those with secondary adhesive capsulitis following breast cancer treatment after failure of conservative management. Adults aged eighteen to sixty five years with significant shoulder pain and restriction of passive range of motion will undergo image guided hydrodilatation followed by a standardized rehabilitation program. Pain relief functional improvement range of motion and quality of life will be assessed at baseline and at one three and six months after intervention. Shoulder Pain and Disability Index will be used as the primary outcome measure while pain intensity quality of life recovery timelines shoulder dyskinesia scar related restriction and rehabilitation adherence will be evaluated as secondary outcomes. The study aims to determine whether post breast cancer adhesive capsulitis shows a different pattern of recovery compared to primary adhesive capsulitis with the expectation that both groups will improve but primary adhesive capsulitis will demonstrate faster and greater functional recovery due to fewer structural and treatment related tissue changes.

 
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