| 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
|
|
|
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
|
|
|
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
|
|
|
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. |