| CTRI Number |
CTRI/2026/03/105230 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Extracoporeal shockwave therapy versus ultrasound therapy on functional ability, pain and range of motion in grade 2 & 3 knee osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Extracoporeal shockwave therapy versus ultrasound therapy on functional ability, pain and range of motion in patients with grade 2 & 3 knee osteoarthritis |
| Trial Acronym |
ESWT-UST-FPRO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek |
| Designation |
MPT Student |
| Affiliation |
Pandit Deendayal Upadyaya National Institute for Person with Physical Disabilities (Divyangjan) |
| Address |
4, Vishnu Digamber Marg, New Delhi-110002
New Delhi DELHI 110002 India |
| Phone |
9643971718 |
| Fax |
|
| Email |
abhishektomer82@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Rajni Kalra |
| Designation |
Assistant Professor PT |
| Affiliation |
Pandit Deendayal Upadyaya National Institute for Person with Physical Disabilities (Divyangjan) |
| Address |
4, Vishnu Digamber Marg, New Delhi-110002
New Delhi DELHI 110002 India |
| Phone |
9599833554 |
| Fax |
|
| Email |
rajnikalra70@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mrs Rajni Kalra |
| Designation |
Assistant Professor PT |
| Affiliation |
Pandit Deendayal Upadyaya National Institute for Person with Physical Disabilities (Divyangjan) |
| Address |
4, Vishnu Digamber Marg, New Delhi-110002
New Delhi DELHI 110002 India |
| Phone |
9599833554 |
| Fax |
|
| Email |
rajnikalra70@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Rehabilitation and academic Institute] |
|
|
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 |
| Abhishek |
Pandit Deendayal Upadyaya National Institute for Person with Physical Disabilities (Divyangjan) |
4, Vishnu Digamber Marg, New Delhi-110002 New Delhi DELHI |
9643971718
abhishektomer82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Committee Pandit Deendayal Upadhyaya National Institute For Persons With Physical Disabilities (Divyangjan) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extracorporeal Shockwave Therapy |
Once per week For 4 Weeks with Conventional knee Exercises |
| Comparator Agent |
Ultrasound Therapy |
5 days Per week For 4 weeks with conventional Knee Exercises |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed with Knee Osteoarthritis (Grade 2 or 3) according to the Kellgren and Lawrence scale, as diagnosed by an experienced orthopedician.
2. Age range: 45-70 years.
3. Chronic knee pain
4. Ability to complete all outcome measures.
|
|
| ExclusionCriteria |
| Details |
1. Other Joint Disorders affecting mobility w
2. Recent Knee Surgery within the past 6 months or have a prosthetic knee joint
3. Other Musculoskeletal Conditions that affect gait or mobility will be excluded.
4. Cardiovascular or Systemic Conditions
5. Use of Medications
6. Inability to Follow Protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lower Extremity Functional Scale (LEFS) |
At Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
At Baseline and after 4 weeks |
| Range of Motion (ROM) |
At Baseline and after 4 weeks |
| Time Up and Go Test (TUG) |
At Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
13/03/2026 |
| 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="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
|
Knee osteoarthritis is a common degenerative joint disorder that leads to pain, reduced range of motion, and difficulty in performing daily activities. Physiotherapy interventions play an important role in the conservative management of knee osteoarthritis. Among various treatment options, Extracorporeal Shock Wave Therapy (ESWT) and Ultrasound Therapy (US) are frequently used modalities; however, limited evidence is available comparing their effectiveness.
This randomized clinical trial aims to compare the effectiveness of Extracorporeal Shock Wave Therapy and Ultrasound Therapy on functional ability, pain, and range of motion in patients with Grade 2 and Grade 3 knee osteoarthritis. A total of 40 participants diagnosed with Grade 2 and 3 knee osteoarthritis will be randomly allocated into two groups. The experimental group will receive ESWT once a week for four weeks, while the control group will receive Ultrasound Therapy five days a week for four weeks. Both groups will also receive a standardized exercise program as part of routine physiotherapy care.
Outcome measures will be assessed at baseline and after completion of the four-week intervention period. The findings of this study may help in identifying a more effective physiotherapy intervention for improving functional outcomes in patients with knee osteoarthritis. |