| CTRI Number |
CTRI/2025/07/090399 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to test whether symptoms of patients with achilles tendinopathy improve through Laser Therapy or not |
|
Scientific Title of Study
|
Efficacy of high intensity laser therapy on shearwave elastography parameters in patients with Achilles Tendinopathy: A Pilot feasibility study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Bathla |
| Designation |
Student |
| Affiliation |
MMIPR, MM(DU), Mullana-Ambala, Haryana. |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
09149129055 |
| Fax |
|
| Email |
muskanbathla1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manu Goyal |
| Designation |
Professor and Principal |
| Affiliation |
MMIPR ,MM(DU),Mullana-Ambala, Haryana. |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manu Goyal |
| Designation |
Professor and Principal |
| Affiliation |
MMIPR ,MM(DU),Mullana-Ambala, Haryana. |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Muskan Bathla
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Muskan Bathla |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
| Type of Sponsor |
Other [self] |
|
|
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 Muskan Bathla |
MM Super Specialty Hospital Mullana-Ambala |
Room no: S113,1st floor, MM Super Specialty Hospital,Mullana-Ambala,Haryana.
Ambala
HARYANA |
9149129055
muskanbathla1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana,Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Intensity Laser Therapy |
High Intensity laser will be administered to the patients having achilles tendinopathy at a wavelength of 980 nm in continuous, static mode for 3 sessions alternatively. A total of 3120 Joules of energy will be delivered to the participants. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 20 to 40 years
Individuals with Chronic Achilles tendinopathy (mid – portion and insertional)
Individuals with BMI 18.5 to 24.9 Kg meter square
Pain for at least 6 months and NPRS pain more than 5
|
|
| ExclusionCriteria |
| Details |
Individuals with age less than 20 years and more than 40 years
Individuals with BMI less than 18.5 kg meter square and more than 25 kg per meter square
Pregnancy
Peripheral neuropathy
Rheumatoid arthritis with foot deformities
Acute inflammation around achilles tendon
Peripheral vascular diseases
Patients taking other treatments for the condition from last 3 months
Individuals with neurological disorders
Metallic Implants
Lower extremity surgeries
Anticoagulant or immunosuppressive therapy in the prior month
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shear-wave elastography |
Baseline and at the end of 3rd session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
Range of motion (using goniometry) |
Baseline and at the end of 3rd session |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
16/07/2025 |
| 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="8"
Days="27" |
|
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
|
Achilles tendinopathy (AT) is characterized by pain, swelling, impaired performance ability, and pathologic changes in and around the tendon. High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols of physiotherapy. The benefits of this non-invasive, painless, and convenient method include increased joint mobility, effective deep tissue stimulation, anti-inflammatory and analgesic effects, and more. Shear wave imaging has the benefit of offering quantitative measurements in a comparatively limited area of the tendon, making it possible to precisely identify and quantify tendon disease, which is known to affect distinct locations. It is yet unclear how HILT will affect the achilles tendons shear-wave elastography parameters over time in individuals with achilles tendinopathy. |