| CTRI Number |
CTRI/2024/10/075306 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| 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
|
Mobilization versus Ultrasound Therapy with Conventional Exercises for Frozen Shoulder |
|
Scientific Title of Study
|
To compare the effects of mobilization versus ultrasound therapy with conventional exercises in Adhesive Capsulitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Jain |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Physiotherapy Ortho Lab, Department of Physiotherapy,Mahatma Gandhi Physiotherapy College, RIICO Institutional Area ,
Sitapura, Tonk Road
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7340419506 |
| Fax |
|
| Email |
vanshika1986@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor and Head Physiotherapy Clinical, MGH, MGPC, MGUMST |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Room No. 14, Physiotherapy OPD, Basement, Mahatma Gandhi Hospital, RIICO Institutional Area, Sitapura, Tonk Road
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor and Head Physiotherapy Clinical, MGH, MGPC, MGUMST |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Room No. 14, Physiotherapy OPD, Basement, Mahatma Gandhi Hospital , RIICO Institutional Area ,
Sitapura, Tonk Road
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan (India),302022 |
|
|
Primary Sponsor
|
| Name |
Vanshika Jain |
| Address |
Goverdhan Nath Ji Ka Mandir Opp. Anand Bari Galta Road, Jaipur, Rajasthan (India), 302003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Saleem Akhtar Naqvi |
Mahatma Gandhi Hospital, Jaipur |
Room No.14, Physiotherapy OPD, Basement, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9680154007
physio.sallu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
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 |
| Comparator Agent |
Mobilization along with Conventional Therapeutic exercises (Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Moist Heat). |
Scapular Mobilization technique include
Scapula Superior Glide.
Scapula Inferior Glide.
Scapula Upward Rotation.
Scapula Downward Rotation.
Scapula Distraction.
Scapular mobilizations were given 2 sets of 10 repetitions with a rest interval of 30 seconds between sets. 5 sessions in a week for 4 weeks.Hot packs applied on the target shoulder for 20 minutes prior to the mobilization.
Conventional Exercises to be followed (Pendulum Exercises, Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Moist Heat). |
| Intervention |
Ultrasound Therapy along with Conventional Therapeutic exercises (Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Hot Pack). |
Group A will receive continuous US with 1 MHz frequency and intensity 1.0 W/cm2 intensity with a transducer head for 6 minutes. After coating the skin with an aquasonic gel, US will be delivered by moving the applicator over the anterior, superior and posterior regions of the target joint in slow, overlapping strokes for 4 weeks.
After that moist heat will be applied for 15-20 minutes to shoulder region.
Conventional Exercises to be followed (Pendulum Exercises, Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Hot Pack). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Case of symptomatic adhesive capsulitis.
VAS score 4 to 7.
Restricted ROM. |
|
| ExclusionCriteria |
| Details |
Subjects with Rotator cuff tears and other shoulder ligament injuries.
History of any arthritis related to shoulder History of trauma or accidental injuries / Fracture.
Bilateral Adhesive Capsulitis.
Reflex sympathetic dystrophy, Neurological involvement (stroke, Parkinsonism, radiating pain to arm).
Recent Surgical Intervention.
Other Shoulder Pathologies.
Open Wounds / Ulcerations.
Skin Infections.
Malignancy.
Periarthritis shoulder secondary to fracture, dislocation. |
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analouge Scale
Universal Goniometer |
4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analouge Scale (VAS Scale) |
1st week & 2nd week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
40 Samples will be categorised into two groups with 20 individuals each and will be studied for 3 weeks on the basis of inclusion criteria.
Group A Ultrasound Therapy along with Conventional Therapeutic exercises (Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Hot Pack).
Group A will receive continuous US with 1 MHz frequency and 1.0W/cm2 intensity with a transducer head for 6 minutes. After coating the skin with an aquasonic gel, US will be delivered by moving the applicator over the anterior, superior and posterior regions of the target joint in slow, overlapping strokes for 4 weeks.
After that moist heat will be applied for 15-20 minutes to shoulder region.
Conventional Exercises to be followed (Pendulum Exercises, Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Hot Pack)
Group B Mobilization along with Conventional Therapeutic exercises (Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Moist Heat).
Scapular Mobilization technique include
Scapula Superior Glide.
Scapula Inferior Glide.
Scapula Upward Rotation.
Scapula Downward Rotation.
Scapula Distraction. Scapular mobilizations were given 2 sets of 10 repetitions with a rest interval of 30 seconds between sets. 5 sessions in a week for 4 weeks.Hot packs applied on the target shoulder for 20 minutes prior to the mobilization.
Conventional Exercises to be followed (Pendulum Exercises, Stretching Exercises, Strengthening Exercises, Range of Motion Exercises and Moist Heat).
Treatment would be done under supervision with informed consent. |