| CTRI Number |
CTRI/2023/02/049467 [Registered on: 06/02/2023] Trial Registered Prospectively |
| Last Modified On: |
25/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nerve block and intraarticular injection] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two treatments in frozen shoulder |
|
Scientific Title of Study
|
Comparison of Suprascapular Nerve Block and Capsular Hydrodilatation in Adhesive Capsulitis of Shoulder: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asem Rangita Chanu |
| Designation |
Associate Professor, Department of Physical Medicine and Rehabilitation |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No 19, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
7598621688 |
| Fax |
|
| Email |
rangita8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asem Rangita Chanu |
| Designation |
Associate Professor, Department of Physical Medicine and Rehabilitation |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No 19, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
7598621688 |
| Fax |
|
| Email |
rangita8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asem Rangita Chanu |
| Designation |
Associate Professor, Department of Physical Medicine and Rehabilitation |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No 19, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
DELHI
110029
India |
| Phone |
7598621688 |
| Fax |
|
| Email |
rangita8@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Asem Rangita Chanu |
| Address |
Room No 19, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Asem Rangita Chanu |
Department of PMR, All India Institute of Medical Sciences, New Delhi |
OPD, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
South West
DELHI |
7598621688
rangita8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsular hydrodilatation |
A mixture of Bupivacaine 0.5% (4 ml), triamcinolone (80 mg), Iohexol 2 to 5 ml, and sterile saline to be injected into the glenohumeral joint under CT guidance. Total duration of intervention: ONE TIME procedure. |
| Comparator Agent |
Suprascapular nerve block |
Bupivacaine 0.5% (4 ml) and triamcinolone (80 mg) mixture to be injected in proximity to the suprascapular nerve in the suprascapular notch under ultrasound guidance. Total duration of intervention: ONE TIME procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients of either sex aged between 18 and 75 years attending the outpatient clinic of the Department of Physical Medicine & Rehabilitation with complaints of shoulder pain and stiffness for at least 3 months will be screened for eligibility
b) Clinical diagnosis of AC made by a thorough history and clinical examination of each shoulder
c) Normal plain radiographic appearance and presence of no secondary causes for the patient’s complaints
d) Patients who receive conservative management (hot fomentation of affected shoulder, Codman’s exercise, Range of Motion exercises and activities of affected shoulder, acetaminophen 650mg when required for pain up to a maximum of 5 tablets a day) for at least 2 weeks with no meaningful relief (less than 50% improvement in the passive range of movement in the affected shoulder for at least two of the three movements: forward flexion, abduction or external rotation). |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in function (SPADI score) of the shoulder |
1, 4 and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in passive ROM of the shoulder |
1, 4 and 6 weeks |
| Change in triple-phase bone scan findings of the shoulder |
6 weeks |
| Relationship between ultrasound findings and change in function and passive ROM of the shoulder |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Adhesive capsulitis (AC) of the shoulder is characterized by painful, restricted shoulder ROM in patients with normal radiographs and has long been considered self-limiting with spontaneous resolution (over a period of 18–24 months) that renders invasive treatment modalities superfluous. However, even after a fair trial of conservative measures (e.g., physical modalities, anti-inflammatory medications, exercises, corticosteroid injections), it has been reported that around 30% of patients do not improve clinically, thereby prolonging their functional limitations, emotional and economic hardships. In patients who do not improve with conservative treatment, further invasive treatments (such as manipulation under anesthesia and arthroscopic lysis of adhesions) have been tried. However, there has been no universally accepted method regarding invasive treatment options for refractory cases. Suprascapular Nerve Block (SSNB) has been tried in refractory AC but suboptimal response and complications can occur especially with the surface landmark technique and in the hands of those with limited expertise. Some studies have shown capsular hydrodilatation as a potential non-surgical option in the management of AC. However, its role compared with more established treatments for AC remains undefined. The present study aims to compare the effect of Suprascapular Nerve Block (SSNB) and capsular hydrodilatation in refractory cases of AC of the shoulder. We hypothesize that capsular hydrodilatation is as efficacious as SSNB in refractory cases of AC of the shoulder. |