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CTRI Number  CTRI/2026/02/104080 [Registered on: 17/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [pulsed radiofrequency neuromodulation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pulsed Radiofrequency neuromodulation of three nerves of shoulder joint with Glenohumeral joint hydrodistension vs Pulsed Radiofrequency neuromodulation of the Suprascapular nerve along with Glenohumeral joint hydrodistension for treatment of Adhesive Capsulitis 
Scientific Title of Study   A Comparative Study between Pulsed Radiofrequency neuromodulation of three nerves of shoulder joint i.e Suprascapular, Axillary and Lateral pectoral nerve along with Glenohumeral joint hydrodistension vs Pulsed Radiofrequency neuromodulation of the Suprascapular nerve along with Glenohumeral joint hydrodistension for treatment of Adhesive Capsulitis. A Prospective Randomised Controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Poddar 
Designation  Senior consultant, Department of Pain Medicine 
Affiliation  CENTRAL HOSPITAL, SOUTH EASTERN RAILWAYS, GARDEN REACH, KOLKATA 
Address  Department of Pain Medicine, Central Hospital, South East Railways, Garden reach,Kolkata, WEST BENGAL

Kolkata
WEST BENGAL
700043
India 
Phone  9830048445  
Fax    
Email  drpoddark@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samir Basak 
Designation  Senior consultant, Department of Pain Medicine 
Affiliation  CENTRAL HOSPITAL , SOUTH EASTERN RAILWAYS, GARDEN REACH, KOLKATA 
Address  Department of Pain Medicine, Central Hospital, South East Railways, Garden reach, Kolkata 700043

Kolkata
WEST BENGAL
700043
India 
Phone  9002080538  
Fax    
Email  drsamirbasak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Samir Basak 
Designation  Senior consultant, Department of Pain Medicine 
Affiliation  CENTRAL HOSPITAL , SOUTH EASTERN RAILWAYS, GARDEN REACH, KOLKATA 
Address  Department of Pain Medicine, Central Hospital, South East Railways, Garden reach, Kolkata 700043

Kolkata
WEST BENGAL
700043
India 
Phone  9002080538  
Fax    
Email  drsamirbasak@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  CENTRAL HOSPITAL 
Address  Department of Pain Medicine, Central Hospital, South East Railways, Garden reach, Kolkata 700043 
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 Samir Basak  Central Hospital, South East Railways, Garden reach, Kolkata 700043  Department of Pain Medicine
Kolkata
WEST BENGAL 
9002080538

drsamirbasak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE, CENTRAL HOSPITAL, SOUTH EASTERN RAILWAY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pulsed Radiofrequency neuromodulation of 3 nerves Suprascapular, Axillary and Lateral pectoral nerve along with Glenohumeral joint hydrodistension  Pulsed Radiofrequency neuromodulation of three nerves of shoulder joint i.e Suprascapular, Axillary and Lateral pectoral nerve for 240 seconds at 42 degree along with Glenohumeral joint hydrodistension with 40 ml dextrose, ropin and distilled water for treatment of Adhesive Capsulitis 
Comparator Agent  Pulsed Radiofrequency neuromodulation of Suprascapular nerve along with Glenohumeral joint hydrodistension   Pulsed Radiofrequency neuromodulation of Suprascapular nerve along with Glenohumeral joint hydrodistension for treatment of Adhesive Capsulitis 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients with Chronic pain (existing for more than three months at the time of examination) in the shoulder diagnosed as Adhesive Capsulitis
2.Refractory to conservative treatment
3.Willing to give consent for study
4.The positive effect of the test blockade of the suprascapular, axillary and lateral thoracic nerves with a local anaesthetic (reduction of the pain level from the baseline according to NRS by at least 50%)
 
 
ExclusionCriteria 
Details  1.Red flag signs- trauma leading to fracture, dislocation, complete tear, malignancy, septic arthritis
2.Allergy to local anaesthetics, drugs
3.Localized infection at site, Fever
4.Coagulopathy
5.Pregnant females
6.Patient on pacemakers
7.Instability of the shoulder joint
8.Cervical radiculopathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in Pain (NRS score)
2. Functional activity of shoulder joint (SPADI score, Range of motion) 
15 days and 3 months, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
• Secondary outcome – Any adverse effects (eg pain, infection, bleeding, paralysis) and duration of improvement.  15 days and 3 months, 6 months and 12 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2 
Date of First Enrollment (India)   17/03/2026 
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="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 - NO
Brief Summary  

All patients in both groups will undergo shoulder radiography before the treatment, and the etiology of adhesive capsulitis documented by magnetic resonance imaging (MRI) findings and clinically.

After checking patient’s written informed consent for the procedure and NPO status, patients will be shifted to operation theatre. In the operative room, a 20 G I.V cannula will be inserted and co-loading will be done with crystalloid (RL). Monitoring will include pulse oximetry, non-invasive blood pressure, 5 lead standard electrocardiogram (ECG). All the patients in both groups will be informed about procedure, NRS and SPADI scoring system. Patients in both groups will be placed in respective lateral position (right lateral for left shoulder joint procedure and vice versa). Grounding electrode adhesive pad will be applied to another arm/forearm. Pre-scanning will be done prior to procedure. All the procedures will be done under ultrasound guidance using high frequency linear probe. Under aseptic precautions and local anesthesia (1% lignocaine), Radiopaque radiofrequency cannula (Avanos®, 22 G, 100 mm*10 mm) will be introduced. Before radiofrequency neuromodulation, further needle position will be confirmed with sensory and motor stimulation done at 50 Hz up to 0.6 V and 2 Hz up to 1.2 V respectively.

In group P1 Pulsed RF neuromodulation will be done for Suprascapular nerve at 42 degree C for 240 sec.

In group P3 Pulsed RF neuromodulation will be done for Suprascapular nerve, Lateral pectoral nerve and Axillary nerve at 42 degree C for 240 sec.

 For Lateral pectoral nerve PRF, probe will be placed in transverse plane, and needle introduced in-plane approach from lateral to medial side. For Suprascapular nerve PRF, probe will be placed along spine of scapula in transverse plane and needle introduced in-plane approach. For Axillary nerve, probe was placed in coronal plane, along the long axis of humerus and needle introduced in-plane approach. This will be followed by instillation of 1 ml of a 10 ml solution containing 18 mg ropivacaine and 40 mg triamcinolone.

After Pulsed Radiofrequency neuromodulation, Hydrodistension of glenohumeral joint (25% Dextrose 20 ml + Ropivacaine 0.2% 10 ml + distilled water 10 ml) will be done using 20 G Quincke’s spinal needle in both the groups. Hydrodistension will be done in posterior approach, probe will be placed below the spine of scapula and needle introduced in-plane from lateral aspect of the probe. It will be done till the visible joint capsule distension on USG. It will be further confirmed with jet of injected fluid coming out of spinal needle hub after removal of syringe. After procedure shoulder joint movement will be done passively.

All the patients will be discharged on same day and will be reviewed after 15 days and 3 months, 6 months and 12 months. Patients will be followed up regarding pain and range of motion using NRS score, SPADI score and Goniometer.

Patients will be evaluated using a numeric rating scale (NRS) for pain, ranging from none (0) to extreme. The Shoulder Pain and Disability Index (SPADI), a 13-item scale, was used to assess improvement in shoulder function ( 0-20 : Mild pain and disability, 21-40 : Moderate, 41-60 : Severe ,61-80 : Very severe, 81-100 : Extremely severe pain and disability ). The NRS and SPADI, will be measured before the treatment and at 15 days, 1 month, 3 months, 6 months, 12 months after the treatment.

 
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