| CTRI Number |
CTRI/2023/01/048899 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
29/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Reflexive neuromuscular stabilization and black burn exercises among young athletes with rotator cuff tendinitis. |
|
Scientific Title of Study
|
Effectiveness of Reflexive Neuromuscular Stabilization Versus Black Burn Exercises on Pain, Function and Range of Motion among young Athletes with Rotator Cuff Tendinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purvi Verma |
| Designation |
MPT scholer |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no.230, Parul sevashram Hospital
P.O, Limda, Parul University, Vadodara, Gujrat.
Vadodara
GUJARAT
391760
India |
| Phone |
8849383964 |
| Fax |
|
| Email |
vermapurvi94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmang Vyas |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no.230, Parul sevashram hospital
P.O, Limda, Parul University, Vadodara, Gujrat.
Vadodara
GUJARAT
391760
India |
| Phone |
8758958568 |
| Fax |
|
| Email |
dharmang.vyas@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purvi Verma |
| Designation |
MPT scholer |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
ROOM NO.230,PARUL SEVASHRAM HOSPITAL P.O, Limda, Parul University, Vadodara, Gujrat.
Vadodara
GUJARAT
391760
India |
| Phone |
8849383964 |
| Fax |
|
| Email |
vermapurvi94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of Physiotherapy, Parul University, P.O limda, Vadodra -gujrat |
|
|
Primary Sponsor
|
| Name |
Parul Sevashram Hospital |
| Address |
P.O, Limda, Parul University, Vadodara, Gujrat. |
| Type of Sponsor |
Private 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 Purvi Verma |
Parul Sevashram Hospital |
Physiotherapy department, room no. 201
Vadodara
GUJARAT |
8849383964
vermapurvi94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethical Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Black Burn exercises |
Black burn eercies are a specific set of shoulder exercises meant for strengthening at end ranges of
motion. Will be given for 4 weeks 5 sessions per week on affected side. |
| Intervention |
Reflexive Neuromuscular Stabilization |
This rehabilitation techniques are designed to restore dynamic stability and motor control to an injured
joint. Will be given for 4 weeks 5 sessions per week on affected side. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Restricted Range of shoulder Abduction and External
Rotation.
2.Patients willing to Participate
3.Patients who understand English and/or Gujrati language.
|
|
| ExclusionCriteria |
| Details |
1.Partial thickness, full thickness tear or surgical repair of rotator cuff muscle/tendon
2.History of Fracture or dislocation of shoulder/elbow
3.History of any neurological, neuromuscular or vascular disorders
4.Systemic disorders such as rheumatoid arthritis, AS etc.
5.Non cooperative patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Western Ontario Rotator Cuff Index
|
Ater 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goniometry |
After 4 weeks |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/01/2023 |
| 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="0"
Months="6"
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
|
AIMS AND OBJECTIVES
 Aims :
The Aim of the study is to Compare the effect of Reflexive Neuromuscular Stabilization
Exercises Versus Black Burn Exercises on Pain, Range of motion and Function on Rotator
Cuff Tendinitis Among Young Athletes.
Objectives :
ï‚· To evaluate the effect of reflexive neuromuscular stabilization on pain in young athletes
with acute rotator cuff tendinitis ï‚· To evaluate the effect of reflexive neuromuscular stabilization on Range of Motion in
young athletes with acute rotator cuff tendinitis. ï‚· To evaluate the effect of reflexive neuromuscular stabilization on Function in young
athletes with acute rotator cuff tendinitis. ï‚· To evaluate the Effect of Black Burn Exercises on Pain in Young Athletes with Acute
Rotator Cuff Tendinitis ï‚· To evaluate the Effect of Black Burn Exercises on Range of Motion in Young Athletes
with Acute Rotator Cuff Tendinitis. ï‚· To evaluate the Effect of Black Burn Exercises on Function in Young Athletes with
Acute Rotator Cuff Tendinitis. ï‚· To compare the effect of Reflexive Neuromuscular Stabilization and Black Burn
Exercise on Pain in young athletes with acute rotator cuff tendinitis ï‚· To compare the effect of Reflexive Neuromuscular Stabilization and Black Burn
Exercise on Range of Motion in young athletes with acute rotator cuff tendinitis ï‚· To compare the effect of Reflexive Neuromuscular Stabilization and Black Burn
Exercise on Function in young athletes with acute rotator cuff tendinitis
Participants are divided in two Groups Group A and Group B Group A will receive Reflexive Neuromuscular Stabilization Group B will receive Black Burn Exercies |