| CTRI Number |
CTRI/2025/09/095094 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of TECAR therapy with Physiotherapy on Pain,Movement, Strength and Daily Activities in Frozen Shoulder: A Randomised Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of TECAR therapy with Conventional Physiotherapy in Adhesive Capsulitis on Pain, Function, Strength and Disability: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhalchandra Kharsade |
| Designation |
Associate professor |
| Affiliation |
MGM School of Physiotherapy, Chhatrapati Sambhajinagar |
| Address |
Mahatma Ghandi Mission Rehabilitation and Fitness Center, Cidco, N6, Chhatrapati Sambhajinagar- 431003 Musculoskeletal Physiotherapy Department, MGM School of Physiotherapy, Cidco Chhatrapati Sambhajinagar Aurangabad MAHARASHTRA 431003 India |
| Phone |
7038111952 |
| Fax |
|
| Email |
drbhalchandrakharsade@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Bhalchandra Kharsade |
| Designation |
Associate professor |
| Affiliation |
MGM school of physiotherapy, Chhatrapati Sambhajinagar |
| Address |
Mahatma Ghandi Mission Rehabilitation and Fitness Center, cidco, Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431003 India |
| Phone |
7038111952 |
| Fax |
|
| Email |
drbhalchandrakharsade@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Abhijeet Sharma |
| Designation |
UG Student |
| Affiliation |
MGM school of physiotherapy, Chhatrapati Sambhajinagar |
| Address |
Mahatma Ghandi Mission Rehabilitation and Fitness Center, cidco, Chhatrapati Sambhajinagar
MAHARASHTRA 431003 India |
| Phone |
7066686002 |
| Fax |
|
| Email |
abhijeetgsharma007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
Mahatma Ghandi Mission Rehabilitation and Fitness Center, Cidco, Chhatrapati Sambhajinagar, 431001, India |
| 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 Abhijeet Sharma |
Sports Opd, MGM School of Physiotherapy |
Sports OPD, OPD no 3, Mahatma Ghandi Mission Rehabilitation and Fitness Centre, Chhatrapati Sambhajinagar,431003 Aurangabad MAHARASHTRA |
7066686002
abhijeetgsharma007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Ghandi Mission’s Ethics Committee for Research on Human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M368||Systemic disorders of connective tissue in other diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Stretches of levator scapule, upper trapezius, pectoralis major.
Active range of motion exercises and strengthening exercises to middle, lower trapezius and rotator cuff muscles.
Wand exercises.
Pendular exercises.
Mobilization anteroposterior, posteroanterior, and inferior glide.
|
| Intervention |
TECAR therapy |
Mode: Resistive mode
Stainless steel plate placed under affected scapula
Intensity: 30 %
Time: 15 min |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
Individual with Shoulder Pain and Stiffness.
Individuals diagnosed with adhesive Capsulitis.
Individuals with positive Scratch test.
Patient with moderate shoulder pain on VAS. |
|
| ExclusionCriteria |
| Details |
Pregnant woman.
Cervical radiculopathy.
Individuals who are on corticosteroid treatment.
Cancer patients or carcinoma.
Cardiovascular diseases patients.
Neurological impairment.
Mentally disturbed.
Post traumatic upper limb fracture.
Post operative mental implanted. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
1 st day and 9 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability of arm, shoulder and hand |
Total 30 questions
5 points |
| Goniometer |
0 to 360 degrees |
| Manual Muscle Testing |
5 grading |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2025 |
| 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
|
The study is a Randomized Controlled Trial consisting of two groups Group A( Experimental group) and Group B( Conventional group). Participants will be recruited on the basis of inclusion and exclusion criteria, 18 in each group then group A will be given TECAR therapy with conventional therapy of 9 sessions for 3 weeks and group B will be given conventional therapy( stretching, strengthening, ROM exercises, etc) of 9 sessions for 3 weeks. Pre and post intervention outcomes will be taken on first and last day of intervention then result will be analyzed. |