| CTRI Number |
CTRI/2026/02/102757 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| 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
|
A study to compare ultrasound therapy and long-wave therapy along with exercises for reducing pain and improving shoulder function in people with biceps tendon pain. |
|
Scientific Title of Study
|
Effectiveness of therapeutic ultrasound versus long wave therapy with strengthening exercise on pain strength and functional impairment of shoulder in bicipital tendinitis RCT |
| 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 kshitija sanjay reddy |
| Designation |
Masters of Musculoskeletal Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of musculoskeletal Physiotherapy, OPD no 15 Maharashtra Institute of Physiotherapy, MIMSR medical Campus Ambajogai road, Latur 413531, Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
8530862003 |
| Fax |
|
| Email |
kshitijareddy8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
Professor and HOD of Department of Musculoskeletal Physiotherapy latur |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Department of Musculoskeletal Physiotherapy OPD-15 Maharashtra Institute Physiotherapy
NIL
Latur
MAHARASHTRA
413531
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
Professor and HOD of Department of Musculoskeletal Physiotherapy latur |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Department of Musculoskeletal Physiotherapy OPD-15 Maharashtra Institute Physiotherapy
NIL
Latur
MAHARASHTRA
413531
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR medical campus Ambajogai Road Latur Latur MAHARASHTRA 513531
India |
| 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 |
| Dr kshitija Sanjay Reddy |
Maharashtra Institute of Physiotherapy latur maharashtra 413531 |
Department of musculoskeletal Physiotherapy, OPD no 15 Maharashtra Institute of Physiotherapy, MIMSR medical Campus Ambajogai road, Latur 413531, Maharashtra
Latur
MAHARASHTRA |
8530862003
kshitijareddy8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee For Reserch On Human Subject |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M752||Bicipital tendinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
long wave therapy
|
Participants will receive long wave therapy with strengthening exercises in a seated position, using Aqua Sonic gel and continuous circular probe movement over the painful shoulder region
Treatment will be delivered for 5 minutes at a power output of 0.9 W and intensity of 74 W/cm² for 5 times a week for 2 weeks
|
| Comparator Agent |
therapeutic ultrasound |
Participants will receive therapeutic ultrasound in pulsed mode combined with shoulder strengthening exercises, administered in a seated position using Aqua Sonic gel with continuous circular probe movement.
Ultrasound will be applied for 5 minutes at an intensity of 2 W/cm² for 5 times week for 2 week
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient clinically diagnosed with bicipital tendinitis
Age between 20 years to 60 years
Both genders male and female |
|
| ExclusionCriteria |
| Details |
Recent fracture in proximal joint less than 6 months duration.
Any psychological disorder.
Previous surgery or rotator cuff injury.
Unstable shoulder
Infection
6. Shoulder pain in neurological condition. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Shoulder pain
and disability
index(SPADI)
2)Manual muscle testing
|
pre and Post treatment effect will be assessed at 0 week and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
13/02/2026 |
| 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="1"
Months="0"
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 to identify the Effect of therapeutic ultrasound Versus long wave therapy along with strengthening exercise on Pain, strength and functional impairment in patients with bicipital tendinitis A Randomized Controlled Trial Approval for the research work will be obtained from Institutional Ethical committee The purpose of the study will be explained to each participant and a written informed consent will be taken in a language they understand. Participants will be screened and recruited for the study based on inclusion and exclusion criteria. Participants will be added in group A and group B by simple random sampling. Simple random sampling will be done using chit method. Participants in Group A will receive therapeutic ultrasound along with strengthening exercises . Participants in Group B will receive long wave therapy along with strengthening exercises. Data normality will be checked by using the Shapiro–Wilk test. Statistical analysis will be done by using paired T-test and unpaired t-tests. Paired t-test will be used for within-group analysis. Unpaired t-test will be used between the group analysis. P-v will be calculated, which should be <0.05 |