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CTRI Number  CTRI/2019/05/019037 [Registered on: 10/05/2019] Trial Registered Prospectively
Last Modified On: 15/05/2025
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   How is Low Level Laser Therapy effective in improving pain and functions in patients with anterior cruciate ligament reconstruction compared to conventional therapy? 
Scientific Title of Study   Effect of Low Level Laser Therapy on pain and functions in patients with Anterior Cruciate Ligament Reconstruction:An Experimental study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1232-7519  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreeraj S R 
Designation  Dr 
Affiliation  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy MGM Super speciality Hospital Plot No. 46, Sector 30, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone  9769503069  
Fax    
Email  sreeraj_sr@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Khushali Kirti Shah 
Designation  PG Student 
Affiliation  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy MGM Super speciality Hospital Plot No. 46, Sector 30, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone  9819031455  
Fax    
Email  shahkhushali94@gmail.com  
 
Details of Contact Person
Public Query  
Name  Khushali Kirti Shah 
Designation  PG Student 
Affiliation  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy MGM Super speciality Hospital Plot No. 46, Sector 30, Vashi, Navi Mumbai


MAHARASHTRA
400705
India 
Phone  9819031455  
Fax    
Email  shahkhushali94@gmail.com  
 
Source of Monetary or Material Support  
MGM College of Physiotherapy & MGM Medical College Hospital, Navi Mumbai 
 
Primary Sponsor  
Name  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy MGM Super speciality Hospital Plot No. 46, Sector 30, Vashi, Navi Mumbai 400705 
Type of Sponsor  Research institution and hospital 
 
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 
Khushali Kirti Shah  MGM Medical College Hospital, Navi Mumbai  At. Junction NH-4, Sion-Panvel Expressway. Plot No. 1 & 2, Sector-1, Kamothe, Navi Mumbai-410 209 Raigarh, MAHARASHTRA
Raigarh
MAHARASHTRA 		 9819031455

shahkhushali94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MUHS IERC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional Physical therapy  1. Ankle pumps B/L (10 reps x 2 sets). 2. Active assisted Range of motion and active range of motion exercises. (10 reps x 2sets). 3. Muscle setting quadriceps, hamstrings and adductors. (5 reps x 2 sets) 4. VMO strengthening (5 reps x 2sets). 5. Dynamic quadriceps (5 reps x2 sets). 6. Gait training. (According to the condition of patient with brace if recommended start with partial weight bearing) 7. Cryotherapy for swelling and if pain persist. 8. Straight leg raise with brace in full extension until quadriceps strength is sufficient to prevent the extension lag. 9. Achieve full extension, start from 30degrees of knee flexion and progress to 90degrees of knee flexion. 
Intervention  Low-level LASER therapy (LLLT)  Low-level laser therapy (LLLT) is direct application of light to stimulate cell responses (photobiomodulation) to promote tissue healing, reduce inflammation and induce analgesia. LLLT is gaining popularity as a physiotherapeutic modality for wound management, to promote tissue repair, reduce inflammation and anti nociceptive because of its bio-stimulative effects. The treatment parametres are as follows: • Wave length: 600nm. • Time of the treatment: 5minutes. • Energy density: 5J/cm2. • Automatic scanner: transvesre across the knee joint, Anterior  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. All subjects who underwent unilateral ACL reconstruction surgery.
2. All subjects with patellar or hamstring tendon autograft
 
 
ExclusionCriteria 
Details  1. Subjects who have undergone ACL reconstruction with injury of meniscal, medial or lateral collateral ligament injury and posterior cruciate ligament injury.
2. Active carcinogenic conditions
3. Neurological deficit
4. Altered skin sensation
5. Any other recent fracture or surgery to the affected lower limb or revised surgery.
6. Previously operated knee for ligament injury.
7. Bilateral anterior cruciate ligament Reconstruction.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Numerical rating Scale for Pain
2. Digital goniometer for joint range of motion
3. Chattanooga Stabilizer Pressure Biofeedback for muscle strength testing. 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
4. Joint position sense (proprioception) by digital goniometer
5. WOMAC –CRD Pune Version for Functional Status of the subject 		 6 months 
 
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   Phase 1 
Date of First Enrollment (India)   15/05/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 Under manuscript writing 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sreeraj_srf@outlook.com].

  6. For how long will this data be available start date provided 07-12-2021 and end date provided 07-12-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

The objectives of this study were to find the effect of Low-level laser therapy (LLLT) on pain ,Range of motion (ROM), Muscle strength, proprioception and functional abilities and to compare the change in pain, Range of motion, muscle strength, proprioception and functional abilities outcome between the control and experimental group.

The subjects were randomly allocated in group1(conventional) and group2(experimental) with 13 subjects in each group. Group 1 was given conventional therapy and Group2 was given conventional therapy along with Low-level laser therapy(LLLT) 5times a week for 3weeks .The pain, Range of motion (ROM), muscle strength ,proprioception and Functional abilities were checked using NRS, Digital Goniometer, Chattanooga Bio pressure feedback, Mean angle of error(Digital goniometer) and Womac Pune version respectively after ACL Reconstruction in knee at pre before the intervention started, 3 weeks after the intervention and at 6 weeks (follow up) reading .The following measurements were taken at pre, 3weeks and 6 weeks .The study results showed significant improvement in Pain , Range of motion and functional abilities in the experimental group compared to control group with p<0.05.Therefore incorporating Low-level laser therapy(LLLT) in early rehabilitation is a promising inclusion along with conventional therapy in order to enhance recovery and improve the functional abilities , increase range of motion and Reduce postoperative pain after ACL reconstruction in the knee.

 
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