| CTRI Number |
CTRI/2025/10/095640 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| 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
|
Assessing the Impact of High-Intensity Laser Therapy on Pain Relief and Functional Recovery Following a Medial Meniscus Knee Injury on young adults. |
|
Scientific Title of Study
|
Effect of High Intensity Laser Therapy on
Pain and Function in Patients with
Medial Meniscal Injury of Knee - An
Experimental 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 |
Afroz Mahernosh Patel |
| Designation |
MPT Scholar |
| Affiliation |
SPB PHYSIOTHERAPY COLLEGE |
| Address |
1/79,Parsiwad,Opp.Rajratna Avenue, Singanpor,Surat Room number 4
Lower limb OPD ( Musculoskeletal department)
SPB PHYSIOTHERAPY COLLEGE
SURAT Surat GUJARAT 395004 India |
| Phone |
6354009696 |
| Fax |
|
| Email |
afrozpatel8976@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dharti Pansala |
| Designation |
Associate Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
Room number 4
Lower limb OPD
Musculoskeletal department
SPB Physiotherpy college ugat bhesan road morabhagal surat
Surat
GUJARAT
India
Surat GUJARAT 394105 India |
| Phone |
8141570075 |
| Fax |
|
| Email |
physiodharti@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Dharti Pansala |
| Designation |
Associate Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
Room number 4
Lower limb OPD ( Musculoskeletal department)
SPB Physiotherpy college ugat bhesan road morabhagal surat
Surat
GUJARAT
India
Surat GUJARAT 394105 India |
| Phone |
8141570075 |
| Fax |
|
| Email |
physiodharti@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Afroz Mahernosh Patel |
| Address |
SPB Physiotherapy College
Lower limb OPD
Musculoskeletal department
Ugat Bhesan Road
Morabhagal Surat Gujarat 395009
India |
| 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 |
| Afroz Patel |
SPB Physiotherapy College Surat |
SPB Physiotherpy college
Lower limb OPD Musculoskeletal department ugat bhesan road morabhagal surat
Surat
GUJARAT Surat GUJARAT |
06354009696
afrozpatel8976@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SPB Physiotherapy College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M798||Other specified soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Intensity Laser Therapy with Conventional physical therapy treatment |
High-intensity laser therapy (HILT) is a non-invasive treatment that uses a high-powered laser to penetrate deep into tissues. The laser delivers a concentrated beam of light energy, which is absorbed by the cells in the target area. This process, known as photobiomodulation, triggers a cascade of physiological reactions. It stimulates the mitochondria within cells to produce more energy , which accelerates the bodys natural healing and regenerative processes.
Conventional treatment for knee meniscus injury include combination of static isometric exercise and pain free range of motion exercises of knee joint and cardiovascular fitness exercises such as cycling.Quadriceps isometric exercise helps to prevent muscle atrophy and maintain nerve-muscle connection without causing any movement or stress on the injured meniscus.Range of motion exercises such as heel slides works to restore knee flexion (bending) and extension (straightening). It is performed in a controlled, pain-free range of motion to improve joint mobility and prevent stiffness without putting excessive pressure on the meniscus.Straight leg raises strengthens the quadriceps and hip flexor muscles. Its a fundamental exercise for building foundational strength in the entire leg while minimizing direct stress on the knee joint. stationary cycling, is introduced to maintain fitness without aggravating the knee |
| Comparator Agent |
Ultrasound therapy |
Ultrasound therapy for a knee meniscus injury uses high-frequency sound waves to promote healing and reduce symptoms. It works by generating deep heat and a "micromassage" at the cellular level, which increases blood flow and cellular activity in the injured area. This process helps to reduce pain and inflammation, accelerate tissue repair, and improve mobility by relaxing tight muscles. Its often used as a supportive modality in a comprehensive physical therapy plan to help a patient recover more effectively and comfortably |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Meniscal tear of Grade 1 and 2 confirmed by recent MRI having symptoms for more than 2 weeks along with diagnosed with Apleys test or McMurray test |
|
| ExclusionCriteria |
| Details |
Patients having History of fracture or surgery in and around knee joint in last 6 months
Congenital or acquired structural deformity of knee
patients who have any structural deformities since birth
Patient who have taken corticosteroids injection in knee joint in last 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain and Functionality |
Baseline, at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2025 |
| 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
|
Title : Effect of High
Intensity Laser Therapy on Pain and Function in Patients with Medial Meniscal
Injury of Knee - An Experimental Study The meniscus is a critical fibrocartilaginous structure within the knee joint, with the medial meniscus forming a C-shaped wedge that covers approximately 50-60% of the medial tibial plateau. Its primary biomechanical functions include shock absorption, load transmission between the femur and tibia, enhancement of joint congruency and stability, and joint lubrication. The medial meniscus is firmly attached to the deep fibers of the medial collateral ligament and the joint capsule, which limits its mobility and renders it more susceptible to injury compared to the more mobile lateral meniscus. Meniscal tears are among the most common orthopedic injuries, affecting a wide demographic. They can occur from acute trauma, typically involving rotational or shearing forces on a flexed, weight-bearing knee, or from degenerative changes that weaken the meniscal tissue over time. The proposal cites a notable incidence of 222 MRI-confirmed meniscal tears per 100,000 people in symptomatic knees. Clinical presentation commonly includes localized joint line pain, effusion (swelling), stiffness, and mechanical symptoms such as a popping sensation at the time of injury, catching, or locking of the knee joint.
The proposed intervention, HILT, is an emerging electrotherapeutic modality that is distinct from the more established Low-Level Laser Therapy (LLLT). HILT utilizes laser beams with a power output greater than 500 mW, allowing for deeper tissue penetration and the rapid delivery of a substantial amount of energy to the target pathology. The therapeutic rationale for HILT is based on its ability to induce photothermal, photochemical, and photomechanical effects at the cellular level. These effects are proposed to stimulate biological processes conducive to healing, including increased cellular metabolism and adenosine triphosphate (ATP) production, enhanced local blood circulation, and modulation of inflammatory mediators. The ultimate clinical goals are analgesia, reduced inflammation, and accelerated tissue repair.
The study is designed as a pre-post experimental trial to be conducted within outpatient physiotherapy departments in Surat, India. The target population consists of male and female patients aged 18 to 40 years with a recent MRI confirming a Grade 1 or Grade 2 traumatic medial meniscal injury. Participants will be randomly allocated to one of two groups. The control group (Group B) will receive a conventional treatment protocol comprising Interferential Current (IFC) therapy and a structured program of therapeutic exercises. The experimental group (Group A) will receive the identical conventional protocol with the addition of HILT. The primary outcomes for the study are pain intensity and knee function. Pain will be quantified using the Numeric Pain Rating Scale (NPRS), a well-validated tool for assessing subjective pain levels. Knee function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS), a comprehensive, patient-reported outcome measure. Notably, the protocol includes the use of the validated Gujarati version of this instrument (KOOS-G) to ensure cultural and linguistic appropriateness for the local population.
The patient will be screened on the basis of inclusion and exclusion criteria and their demographic data will be taken by an assessment Performa. Prior to the Commencement of the study, detailed procedure of the study will be explained to the Patients and a signed informed consent form will be taken from them. Then the Patient will be randomly assigned to a 4-week intervention protocol and allocated randomly to Group A and Group B. The subjects will be allocated to any of the two groups by random allocation using chit method. The therapist will measure pain, Functionality before the intervention on the first day of the Treatment. |