| CTRI Number |
CTRI/2018/08/015229 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
03/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Radiofrequency Abalation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Electromagnetic Waves in the Treatment of Conditions Associated with Pain and Stiffness Around Shoulder Joint |
|
Scientific Title of Study
|
Outcomes of Radiofrequency Treatment in Frozen Shoulder |
| Trial Acronym |
none |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reema Chaudhary |
| Designation |
Junior resident |
| Affiliation |
GSVM medical college |
| Address |
Gsvm medical college
Kanpur
Swaroop nagar
Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415411361 |
| Fax |
|
| Email |
chaudhary.reema133@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Agarwal |
| Designation |
Associate Professor |
| Affiliation |
GSVM medical college |
| Address |
Gsvm medical college
Kanpur
Swaroop nagar
Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415039582 |
| Fax |
|
| Email |
dragarwalsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reema Chaudhary |
| Designation |
Junior resident |
| Affiliation |
GSVM medical college |
| Address |
Gsvm medical college
Kanpur
Swaroop nagar
Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415411361 |
| Fax |
|
| Email |
chaudhary.reema133@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, GSVM Medical College, Kanpur |
|
|
Primary Sponsor
|
| Name |
GSVM Medical College Kanpur |
| Address |
Swaroop Nagar Kanpur |
| 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 |
| Reema Chaudhary |
Department of Anaesthesia |
GSVM Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH |
9415411361
chaudhary.reema133@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, GSVM Medical College, Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pain and Stiffness around shoulder joint , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radiofrequency abalation Once Only |
Continuous mode |
| Comparator Agent |
Radiofrequency Ablation Once Only |
Pulsed mode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with pain and limitation of movement around shoulder joint and normal x-ray of shoulder joint, consenting. |
|
| ExclusionCriteria |
| Details |
Traumatic and infective causes of pain and limitation of movement, Local infection preventing radiofrequency abalation, bleeding diathesis, allergy to local anaesthetic agents,and non-consenting subjects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxford shoulder score 30 or more, 25 percent improvement in range of movement around shoulder joint. |
Oxford shoulder score 30 or more, 25 percent improvement in range of movement around shoulder joint. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 response to conservative treatment.
2 complications of the procedure |
1 month after conservative treatment, 7 days after intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2018 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Frozen Shoulder (Adhesive Capsulitis) is a common debilitating disorder of shoulder joint. Although it is a self limiting disorder it may take several days before remission of symptoms. Existing treatment includes physiotherapy, use of NSAIDS and surgical treatment in non responders. Surgical treatment is manipulation under GA or arthroscopic arthrolysis / release. Surgical methods are to be conducted under GA with its associated morbidity. Proposed method using radiofrequency abalation of suprascapular nerve is a less traumatic, outdoor procedure done under LA. The proposed method not only involves lesser costs and risk to the patient but also provide greater relief to the patient. |