| CTRI Number |
CTRI/2020/03/024366 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
25/05/2021 |
| 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 between the effectiveness of Mirror Exercises and Shoulder Muscle Strengthening on pain, movement and fear of movement in patients with stiff shoulder |
|
Scientific Title of Study
|
Comparison between the effectiveness of Mirror Therapy (MT) and Rotator cuff strengthening on pain, range of motion and kinesiophobia in subjects with 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 |
Utkarsha Kawathekar |
| Designation |
Post Graduate Student |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
RH no 8, Deven Moti Swaroop, Devda Nagar, Besides Patel lawns, Beed by pass road, Aurangabad
MGM Medical College and Research Centre, Institute of Physiotherapy, N-6 , Cidco, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8793865229 |
| Fax |
|
| Email |
utkarshakawathekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rinkle Hotwani |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
J B 12, Singhgad building, ulkanagari, near deepak gruh udyog, Aurangabad
MGM Medical College and Research centre, Institute of Physiotherapy, N-6 , Cidco, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9370312412 |
| Fax |
|
| Email |
drrinklemalani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Utkarsha Kawathekar |
| Designation |
Post Graduate Student |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
RH no 8, Deven Moti Swaroop, Devda Nagar, Besides Patel lawns, Beed by pass road, Aurangabad
MGM Medical College and research Centre,Institute of Physiotherapy, N-6 , Cidco, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8793865229 |
| Fax |
|
| Email |
utkarshakawathekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy, N 6, Cidco,Aurangabad 431001 |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy Aurangabad |
| Address |
MGM Institute of Physiotherapy,
N-6, Cidco, Aurangabad |
| 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 |
| Utkarsha Kawathekar |
MGM Physiotherapy Rehabilitation and Fitness Centre, Aurangabad |
N-6, Cidco, Aurangabad
Aurangabad
MAHARASHTRA |
8793865229
utkarshakawathekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
Approved |
|
|
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 |
Mirror Therapy and Rotator Cuff Strengthening |
Group A-
Mirror therapy-
Treatment duration – 20 min a session.
Treatment duration – 3 weeks (12 sessions)
1.Mirror will be placed in a parasagittal plane so that patient
could see the reflection of the unaffected side in the mirror.
2.The first stage consisted of active flexion, abduction, internal
and external rotation movements of the intact extremity,
each in front of the mirror for the same amount of time.
3.The second stage consisted of active flexion, abduction,
internal and external rotation movements of both shoulders
carried out again in front of the mirror.
Conventional treatment –
1.TENS for 15 min, frequency 150 Hz
2.Pendulum exercises (2 sets of 10 repetitions).
3.Active ROM exercises (2 sets of 10 repetitions).
Group B-
Rotator cuff strengthening exercises-
Treatment duration – 3 weeks (12 sessions)
1.Strengthening exercises will be including isometric and
isotonic exercises.
2.When the pain will not allow isotonic exercises, isometric
exercises to the rotator cuff muscles will be given in standing.
3.Strengthening exercises will be started within the pain limit
and as per the patient’s tolerance.
4.Strengthening will be started by the Thera band and 1 kg
dumbbell.
8-12 repetitions for 3 sets per session.
Thera band exercises-
Thera band exercises will be done in standing.
External rotation.
Internal rotation.
Shoulder abduction.
Exercises with 1kg dumbbell–
External rotation in side lying.
Internal rotation in supine.
Abduction in side lying and standing.
Conventional treatment – 1.TENS for 15 min, frequency 150 Hz.
2.Pendulum exercises (2 sets of 10 repetitions)
3.Active ROM exercises(2 sets of 10 repetitions) |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 40-65.
2.Both males and females.
3.Primary (idiopathic) adhesive capsulitis.
4.Second stage of adhesive capsulitis (frozen or stiff phase).
5.Unilateral shoulder involvement. |
|
| ExclusionCriteria |
| Details |
1.Glenohumeral arthritis or any signs of bony damage due to
any trauma.
2.Any neurological disorders causing muscle weakness (stroke,
myocardial infarction).
3.Any upper limb nerve root entrapment.
4.Lacked comprehensive and language skills to understand the
treatment procedure. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual Analogue Scale
2. Range of Motion
3. Tempa Scale of Kinesiophobia
|
Baseline on the 1st day
post intervention at the end of 3rd week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Analogue Scale
2. Range of Motion
3. Tempa Scale of Kinesiophobia |
10-15 minutes |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2020 |
| Date of Study Completion (India) |
20/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This randomized clinical trial compared the effectiveness of mirror therapy and rotator cuff strengthening on pain, range of motion and kinesiophobia in 36 patients of adhesive capsulitis. Patients enrolled according to the inclusion criteria. Intent of the study was explained and informed consent form was taken from patients. Patients divided into two groups according to appropriate method. Pre-treatment outcomes i.e. pain, range of motion and kinesiophobia assessed and documented. Pain intensity was assessed by visual analogue scale. Range of motion was measured by universal goniometer. And kinesiophobia i.e. fear of movement was documented by tempa scale of kinesiophobia (TSK-11). 12 sessions of treatment was delivered. After completing the protocol, again outcomes was assessed. Data entered in Microsoft Excel and analyzed using SPSS version 24.0th. Data represented in the form of frequency and percentage and also in the form of visual impressions like bar diagram, pie diagram etc. Unpaired student t-test was applied to check significance difference between two groups also paired t-test was applied for checking significant difference between pre and post treatment in a group. P- Value of <0.05 was considered statistically significant. This trial concludes that both techniques are effective but rotator cuff strengthening has been proved to be more effective. |