| CTRI Number |
CTRI/2015/06/005867 [Registered on: 04/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2014 |
| 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
|
Comparison of taping with Mobilization and mobilization alone in subjects with Shoulder Pain. |
|
Scientific Title of Study
|
Efficacy of Kinesio taping as adjunct to Maitland Mobilization in subjects with primary adhesive capsulitis-A Randomized 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 |
RAKHI RATNAM |
| Designation |
Student |
| Affiliation |
KLEU Institute Of Physiotherapy |
| Address |
KLEU Institute Of Physiotherapy.
JNMC Campus,Nehru Nagar
KLEU Institute Of Physiotherapy.
JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
7353177321 |
| Fax |
|
| Email |
msrakhi30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vijay kage |
| Designation |
assistant professor |
| Affiliation |
KLEU Institute Of Physiotherapy |
| Address |
KLEU Institute Of Physiotherapy.
JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
08312474727 |
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjiv kumar |
| Designation |
Principal |
| Affiliation |
KLEU Institute Of Physiotherapy |
| Address |
KLEU Institute Of Physiotherapy.
JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
08312474727 |
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KLE HOSPITAL,BELGAUM,INDIA |
|
|
Primary Sponsor
|
| Name |
KLEU Institute Of Physiotherapy |
| Address |
Dr. Prabhakar kore hospital and Medical research center,JNMC Campus,Nehru Nagar,Belgaum,Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rakhi Ratnam |
KLE’S Dr.Prabhakar Kore Hospital and Medical Research Center. Department Of Physiotherapy. |
Nehru Nagar,Belgaum, Karnataka-590010
KARNATAKA
Belgaum
KARNATAKA |
7353177321
08312474727
msrakhi30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primary adhesive capsulitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kinesitaping and Mailtland mobilization,conventional therapy |
kinesiotape for primary adhesive capsulitis for 6 days, Maitland mobilization grade I,II caudal,AP Glide for 6 days.hot moist pack for 10 mins,shoulder wheel exercises,pendular exercises,capsular stretching single session a day for 6 days |
| Comparator Agent |
Maitland Mobilization,conventional therapy |
Maitland Mobilization grade I,II caudal,AP glide for 6 days,Hot moist pack for 10 mins,shoulder wheel,pendular exercises,Capsular stretching.all interventions given single session a day for 6 days. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
End range shoulder Range of motion limitation,
duration of symptoms-0-6 months |
|
| ExclusionCriteria |
| Details |
rotator cuff pathology
glenohumeral dislocation
rib fracture
any metastatic condition
any shoulder surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS
Shoulder ROM (Flexion,abduction,external rotation), DASH |
Day 1st and Day 6th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS, Shoulder ROM, DASH |
Day 1st and Day 6th |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present randomized clinical study is intended to study the efficacy of kinesiotaping as an adjunct to Maitland Mobilization in subjects with primary adhesive capsulitis.
Hypothesis:
Null Hypothesis {Ho}:
kinesiotaping as an adjunct to Maitland mobilization may not be effective or same as Maitland mobilization in subjects with primary adhesive capsulitis
Alternate Hypothesis {Ha}: Kinesiotaping as an adjunct to Maitland mobilization is more effective than Mailtland mobilization in subjects with primary adhesive capsulitis. |