| CTRI Number |
CTRI/2025/07/090674 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| 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
|
Study on Shockwave Therapy for Front Knee Pain |
|
Scientific Title of Study
|
Effectiveness of Extracorporeal Shockwave Therapy on Pain and Morphological Characteristics of Patellofemoral Pain Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mubashsira Islam Raisa |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No: 304 , Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801737860496 |
| Fax |
|
| Email |
mubashsiraraisa@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kazi Md Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No : 405, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr Kazi Md Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No : 405, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408 Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Dr M R Khan Medical Centre ,Department of Physiotherapy, 3rd floor ,Jashore University of Science and Technology, Jashore-7408 |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room No : 401 ,Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr M R Khan Medical Centre |
Level-3, Room :301, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408
|
8801778315139
kabir2002pt@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Physiotherapy and Rehabilitation,JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extracorporeal Shockwave Therapy with Quadriceps Isometric Strengthening Exercise |
Experimental group will receive on patellar tendon and quadriceps insertion in 8 sessions twice a week , each lasting 15 – 20 minutes for three weeks, with two days gap between sessions using the BTL-6000 Shockwave Therapy device. A total of 2000 pulses were delivered per session at a frequency of 10–15 Hz. The intensity was progressively increased from 0.2 to 0.5 BAR depending on patient tolerance. Receive Quadriceps Isometric Strengthening Exercise which conducted for 10s hold ,2 sets /15 repetitions, 2 min rest between sets. |
| Comparator Agent |
Ultrasound Therapy with Quadriceps Isometric Strengthening Exercise |
Receive Ultrasound Therapy on patellar tendon and quadriceps insertion in 15 sessions every day ,each lasting 15 minutes for three weeks, using Mode : Pulse ; Pulse ratio : 1:1 ; Intensity : 0.8 – 1.0 watts/cm2 ; Frequency : 3MHz – 2.0 mm. Receive Quadriceps Isometric Strengthening Exercise which conducted for 10s hold ,2 sets /15 repetitions, 2 min rest between sets |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Men and women aged between 19 to 60 years.
Individuals with Patellofemoral Pain having a Kujala Score of less than 100.
Presence of any soft tissue lesion or tendinosis in the quadriceps tendon as noted in musculoskeletal ultrasonography (MSK USG).
Presence of any soft tissue lesion or tendinosis in the patellar tendon as noted in musculoskeletal ultrasonography (MSK USG).
Presence of patellofemoral degenerative changes as noted in musculoskeletal ultrasonography (MSK USG).
Able to walk independently without the use of walking aids |
|
| ExclusionCriteria |
| Details |
Patients who contraindicated to ESWT such as pregnant, blood clotting disorders, oral anti coagulants, received steroid injections within 6 weeks, pacemaker fitted, tumor, fracture dislocation, history of tendon rupture (Enfield Osteopathic Field)
Individuals with Infrapatellar bursitis, fat pad impingement, patellar tendinopathy injuries, Osgood Schlatter syndrome. (Enfield Osteopathic Clinic)
History of surgery with past 6 months
Patients with neurological conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain which is measured by Pressure Algometer, Anterior Knee Pain Scale , Knee injury and Osteoarthritis Outcome Score - Patellofemoral subscale and Morphological Characteristics which is measured by Musculoskeletal Ultrasonography imaging |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome will be Functional Activity which is measured by Lower Extremity Functional Scale |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kma.hossain@just.edu.bd].
- For how long will this data be available start date provided 15-09-2025 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The purpose of this single centered, participant and assessor blinded parallel group Randomized Clinical Trial is to examine the effectiveness of ESWT with isometric exercises against UST with isometric exercises to improve pain and morphological characteristics which are primary outcome that measures through Pressure Algometer or Anterior Knee Pain Scale and USG and functional activity which is secondary outcome that measures through Lower Extremity Functional Scale with the patient of Patellofemoral Pain Syndrome. The expected result of this study will be the ESWT with isometric exercise will be effective for pain reducing and significant changes can be found in morphological characteristics. |