| CTRI Number |
CTRI/2020/09/027826 [Registered on: 15/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The comparison of effectiveness of treatment of manipulation of shoulder under block of sensation around shoulder followed by physiotherapy versus physiotherapy alone in treatment of primary adhesive capsulitis |
|
Scientific Title of Study
|
The comparison of efficacy of treatment of manipulation of shoulder under inter scalene brachial plexus block followed by physiotherapy versus physiotherapy alone in treatment of primary adhesive capsulitis: A randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIJAY KUMAR |
| Designation |
JUNIOR RESIDENT DEPARTMENT OF ORTHOPAEDICS AIIMS NEW DELHI |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO-6001, DEPARTMENT OF ORTHOPAEDICS, CONVERGENCE BLOCK, AIIMS CAMPUS, ANSARI NAGAR, NEW DELHI, PIN-110029
DOCTORS DUTY ROOM, AB1 WARD, DEAPRTMENT OF ORTHOPAEDICS, AIIMS, NEW DELHI PIN-110029
South
DELHI
110029
India |
| Phone |
8587861693 |
| Fax |
|
| Email |
vk1963149@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF H L NAG |
| Designation |
PROFESSOR, DEPARTMENT OF ORTHOPAEDICS AIIMS NEW DELHI |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO-6001,DEPARTMENT OF ORTHOPAEDICS, CONVERGENCE BLOCK, AIIMS CAMPUS, ANSARI NAGAR, NEW DELHI, PIN-110029
DOCTORS DUTY ROOM, AB1 WARD, DEPARTMENT OF ORTHOPAEDICS, AIIMS, NEW DELHI PIN-110029
South
DELHI
110029
India |
| Phone |
8587861693 |
| Fax |
|
| Email |
hlnag2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
VIJAY KUMAR |
| Designation |
JUNIOR RESIDENT DEPARTMENT OF ORTHOPAEDICS AIIMS NEW DELHI |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO-6001, DEPARTMENT OF ORTHOPAEDICS, CONVERGENCE BLOCK AIIMS CAMPUS ANSARI NAGAR NEW DELHI PIN-110029
DOCTORS DUTY ROOM, AB1 WARD, DEPARTMENT OF ORTHOPAEDICS, AIIMS NEW DELHI PIN-110029
South
DELHI
110029
India |
| Phone |
8587861693 |
| Fax |
|
| Email |
vk1963149@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORTHOPAEDICS, AIIMS NEW DELHI. AIIMS CAMPUS, ANSARI NAGAR NEW DELHI PIN-110029 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DEPARTMENT OF ORTHOPAEDICS AIIMS CAMPUS, ANSARI NAGAR NEW DELHI PIN-110029 |
| Type of Sponsor |
Government medical college |
|
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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 |
| VIJAY KUMAR |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI |
ROOM NO-6001, DEPARTMENT OF ORTHOPAEDICS, CONVERGENCE BLOCK, AIIMS CAMPUS, ANSARI NAGAR NEW DELHI PIN-110029
South
DELHI |
8587861693
vk1963149@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MANIPULATION OF SHOULDER UNDER INTER SCALENE BRACHIAL PLEXUS BLOCK FOLLOWED BY PHYSIOTHERAPY |
SHOULDER MANIPULATION WILL BE DONE UNDER SINGLE SHOT INTER SCALENE BRACHIAL PLEXUS BLOCK USING ROPIVACAINE 0.375% ALONG WITH CLONIDINE IN DOSE 1.5 MICROGRAM PER KILOGRAM BODY WEIGHT. PARTICIPANT WILL BE KEPT UNDER OBSERVATION IN RECOVERY ROOM FOR 6 HOURS AFTER MANIPULATION. PHYSIOTHERAPY WILL BE STARTED FROM NEXT DAY AFTER MANIPULATION. PHYSIOTHERAPY WILL BE DONE THRICE A WEEK FOR FOUR WEEKS THEN ONCE A WEEK FOR NEXT TWO MONTHS IN ORTHOPAEDICS DEPAERTMENT OPD UNDER SUPERVISION OF SENIOR PHYSIOTHERAPIST. HOT PACK AND MICROWAVE DIATHERMY THERAPY WILL BE APPLIED ON ALTERNATE BASIS. AFTER 3 MONTHS EVERY PATIENT WILL BE GIVEN DEMONSTRATION AND WRITTEN INSTRUCTION FOR RESISTANCE BAND (THERA BAND ) EXERCISES AT HOME FOR NEXT 3 MONTHS. PATIENT WILL BE GIVEN TABLET DICLOFENAC 100 MG ONCE DAILY FOR INITIAL FOUR WEEKS OF PHYSIOTHERAPY THEN AS PER OCCASIONAL REQUIREMENT FOR PAIN CONTROL. |
| Comparator Agent |
ONLY PHYSIOTHERAPY GROUP. |
PHYSIOTHERAPY WILL BE DONE THRICE A WEEK FOR FOUR WEEKS THEN ONCE A WEEK FOR NEXT TWO MONTHS IN ORTHOPAEDICS DEPAERTMENT OPD UNDER SUPERVISION OF SENIOR PHYSIOTHERAPIST. HOT PACK AND MICROWAVE DIATHERMY THERAPY WILL BE APPLIED ON ALTERNATE BASIS. AFTER 3 MONTHS EVERY PATIENT WILL BE GIVEN DEMONSTRATION AND WRITTEN INSTRUCTION FOR RESISTANCE BAND (THERA BAND ) EXERCISES AT HOME FOR NEXT 3 MONTHS.
PATIENT WILL BE GIVEN TABLET DICLOFENAC 100 MG ONCE DAILY FOR INITIAL FOUR WEEKS OF PHYSIOTHERAPY THEN AS PER OCCASIONAL REQUIREMENT FOR PAIN CONTROL. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-CLINICAL DIAGNOSIS OF PRIMARY ADHESIVE CAPSULITIS
-UNILATERAL INVOLVEMENT
-AGE >18 YEARS AND <60 YEARS
-PATIENT GIVING CONSENT
|
|
| ExclusionCriteria |
| Details |
-SECONDARY ADHESIVE CAPSULITIS
-BILATERAL SHOULDER INVOLVEMENT
-AGE < 18 YEARS AND >60 YEARS
-PREVIOUS HISTORY OF INTRA-ARTICULAR CORTICOSTEROID INJECTION, MANIPULATION UNDER ANAESTHESIA, SHOULDER SURGERY, CHEMOTHERAPY OR RADIOTHERAPY
-INABILITY TO GIVE INFORMED CONSENT AND FILL OUT QUESTIONNAIRE |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Disability of the arm, shoulder and hand (DASH) score
|
-BASELINE MEASUREMENT
-AT ONE MONTH FOLLOW UP
-AT THREE MONTHS FOLLOW UP
-AT SIX MONTHS FOLLOW UP
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| THE SHOULDER PAIN AND DISABILITY INDEX (SPADI) SCORE |
-BASELINE MEASUREMENT
-AT ONE MONTH FOLLOW UP
-AT THREE MONTHS FOLLOW UP
-AT SIX MONTHS FOLLOW UP |
Visual analog scale (VAS) for pain
|
-BASELINE MEASUREMENT
-AT ONE MONTH FOLLOW UP
-AT THREE MONTHS FOLLOW UP
-AT SIX MONTHS FOLLOW UP |
Absenteeism at work, evaluated with a single question where patients register the amount of days absent at work past month due to complaints of the shoulder
|
-BASELINE MEASUREMENT
-AT ONE MONTH FOLLOW UP
-AT THREE MONTHS FOLLOW UP
-AT SIX MONTHS FOLLOW UP |
Active assisted range of motion
Shoulder flexion
Shoulder abduction
Shoulder internal rotation
Shoulder external rotation
|
-BASELINE MEASUREMENT
-AT ONE MONTH FOLLOW UP
-AT THREE MONTHS FOLLOW UP
-AT SIX MONTHS FOLLOW UP |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2020 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Purpose of this study is compare efficacy of treatment of manipulation of shoulder under inter scalene brachial plexus block followed by physiotherapy versus physiotherapy alone in primary adhesive capsulitis patients. We hypothesize that the course of the disease can be shortened with manipulation of shoulder under inter scalene brachial plexus block followed by physiotherapy with a quicker functional recovery and better pain control with gain in range of motion compared to physiotherapy alone.
|