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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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