| CTRI Number |
CTRI/2024/04/066466 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [LOCAL ANAESTHESIA WITH LIGNOCAINE ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study at Sawai Man Singh Medical College, Jaipur, Rajasthan to assess the efficiency of sonography guided needle fenestration of coracohumeral ligament for the treatment of frozen shoulder patients in the frozen stage |
|
Scientific Title of Study
|
An Interventional Study To Determine The Effectiveness Of Ultrasound Guided Needle Fenestration Of Coracohumeral Ligament For The Management Of Shoulder Adhesive Capsulitis In The Frozen Stage At Sawai Man Singh Medical College, Jaipur, Rajasthan |
| 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 Rishab Bhagwan Meshram |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Duty Doctor Room
Rehabilitation Research Centre
Department of Physical Medicine and Rehabilitation
SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9437591348 |
| Fax |
|
| Email |
rishabmeshram94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrinal Joshi |
| Designation |
Guide Senior Professor and Unit 1 Head |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
01412561906 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrinal Joshi |
| Designation |
Guide Senior Professor and Unit 1 Head |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
01412561906 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLEGE JAIPUR |
| Address |
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
Rajasthan- 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Mrinal Joshi |
Sawai Man Singh Medical College Jaipur |
Room No 23
3rd Floor
Department Of Physical Medicine And Rehabilitation
Rehabilitation Research Center
PIN code: 302004
Jaipur
RAJASTHAN |
01412561906
dr.m.joshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee SMS Medicalcollege and Attached Hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M75||Shoulder lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
An Interventional Study to Determine the Effectiveness of Ultrasound Guided Needle Fenestration of Coracohumeral Ligament for the Management of Shoulder Adhesive Capsulitis in the Frozen Stage |
The patient will be placed in the supine position, with the affected arm by the side and the shoulder in maximum external rotation, which will be maintained by an assistant. The CH ligament will be longitudinally identified using the USG with a 6 to 13 MHz linear transducer. The skin around the CH ligament will be prepared with 70% isopropyl alcohol (surgical spirit), followed by povidone iodine. The probe will be covered with a sterile, transparent sheet before intervention. Local anesthesia in and around the intervention site will be performed with 8 mL of 2% Lignocaine.The end of the probe will be covered with a transparent sterile dressing, and sterile ultrasound transmission gel will be applied both between the transducer and the sterile cover and on the skin. The ultrasound transducer probe will be placed parallel to the CH ligament and further adjusted to have a coracoid process at its center. A Spinal Anesthesia Needle 20 G will be inserted directly into the coracohumeral ligament about 5–10 mm away from the coracoid process through the skin, subcutaneous tissue, and anterior deltoid muscle with an in-line approach. While the shoulder is in external rotation, fenestration of the coracohumeral ligament will be done while moving the needle tip around the attachment at the coracoid process to cover the coracohumeral ligament as much as possible. The patients will be allowed to return to their daily activities immediately after the procedure and without any restrictions. The patients will continue the exercise as advised. They will be instructed to do ice compression post-procedure and etoricoxib 90mg if required. The number of tablets consumed will be recorded during the subsequent follow-up. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Those willing to give informed written consent for participating in the study
Patients with shoulder adhesive capsulitis in frozen stage
Normal radiological appearance
|
|
| ExclusionCriteria |
| Details |
The patient with poorly controlled Type 2 Diabetes mellitus or HbA1c more than 7.5
The patient with skeletal abnormality of Shoulder girdle or cervical thoracic spine
Patient with any shoulder weakness secondary to Trauma And Spinal cord injury
Patient with bleeding disorder INR more than 1.5 and platelet count less than 1 lakh per mm3
Patient currently with blood thinner eg warfarin etc
The patient with history of shoulder fracture or rotator cuff injury
Those with any other medical or surgical intervention that can interfere with the diagnosis or treatment protocol
Allergy or intolerance to any drug or substance being used in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Shoulder pain and disability index for pain intensity and functional disability assessment
2. Visual analog scale
3.The number of analgesics ingested per day |
Before Intervention at the time of interview ,then follow up at baseline ,2 wks, 4 wks, 6 wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
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)
|
10/05/2024 |
| 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
|
This study is a prospective, cohort ,intention to treat ,interventional clinical trial to evaluate the effectiveness and functional improvement in active ROM and passive ROM in patients with adhesive capsulitis in frozen stage treated with USG guided needle fenestration of the coracohumeral ligament using the shoulder pain and disability index scale. |