| CTRI Number |
CTRI/2025/08/093295 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| 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
|
Comparing Effect Of Super Inductive System Versus Transcutaneous Electrical Nerve Stimulation in Individuals With Frozen Shoulder- A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparing Effect Of Super Inductive System Versus Transcutaneous Electrical Nerve Stimulation on Pain, Mobility and Functional Disability With Frozen Shoulder - A Randomized Clinical 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 |
Swaraj kale |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Room no: no:39 Advanced Physiotherapy Center Sagar floor KLEs DR Prabhakar Kore Hospital and Research center
Belagavi Karnataka
Belgaum
KARNATAKA
431517
India |
| Phone |
08669774249 |
| Fax |
|
| Email |
swarajkale3369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Room no: no:39 Advanced Physiotherapy Center Sagar floor KLEs DR Prabhakar Kore Hospital and Research center
Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Room no: no:39 Advanced Physiotherapy Center Sagar floor KLEs DR Prabhakar Kore Hospital and Research center
Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education And Research |
| Address |
Nehru Nagar, Belagavi, Karnataka, 590010 |
| 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 Swaraj Kale |
KLEs DR.Prabhakar kore hospital and medical research centre, |
Nehru nagar,Belagavi, Karnataka, 590010
Belgaum
KARNATAKA |
08669774249
swarajkale3369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Superinductive system for patients with frozen shoulder |
A superinductive system for patients with frozen shoulder will be given for 5 days for two weeks. |
| Comparator Agent |
Transcutaneous electrical nerve stimulation for patients with frozen shoulder. |
Transcutaneous electrical nerve stimulation for patients with frozen shoulder will be given for 5 days for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
-All genders of age 40 years to 60 years.
- Clinically diagnosed case of Frozen Shoulder (Stage I and II)
-Pain intensity more than 3 on NPRS.
- Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
-Recent Shoulder surgery
-Frozen shoulder secondary to pathologies like shoulder injury, rotator cuff tears, fractures
-Neurological signs of nerve root compression like radiation pain.
-Metal implants in shoulder region.
-Any Open Wounds on shoulder region.
-People under medication
-Taken physiotherapy treatment for shoulder in previous 3 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SPADI scale
Universal goniometer
NPRS |
At baseline on day 1 and after week 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
07/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/03/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Aim-to determine and compare the effect of super
inductive system versus transcutaneous electrical nerve stimulation on pain,
mobility and functional disability in individuals with frozen shoulder.
Inclusion criteria- 1) all genders of age 40 to 60
years
2) clinically diagnosed case of frozen shoulder (
stage I and II)
3) pain intensity more than 3 on NPRS
4) willing to participate in study
Exclusion criteria - 1) Recent shoulder surgery
2) Frozen shoulder secondary to pathologies like
shoulder injury, rotator cuff tear and fracture
3) neurological signs of nerve root compression like
radiation pain
4) metal implant in shoulder region
5) any open wound on shoulder region
6) people under medication
7) taken physiotherapy treatment for shoulder in
previous 3 months
Outcome measures
1) assessment of pain intensity using NPRS
2) assessment of mobility using goniometer
3) assessment of functional disability using SPADI
Procedure
The study participants will there be randomly
allocated in two different groups.
Group A will receive super inductive system with
conventional treatment
Group B will receive transcutaneous electrical nerve
stimulation with conventional treatment.
|