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CTRI Number  CTRI/2026/01/102506 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Laser and Ultrasound Therapy for Treatment of Tennis Elbow 
Scientific Title of Study   Comparative Assessment of Low-level Laser Therapy and Ultrasound Therapy in Patients of Lateral Epicondylitis Attending a Tertiary Care Hospital in Kolkata 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ribhu Bhattacharya 
Designation  Post Graduate Trainee 
Affiliation  R. G. Kar Medical College and Hospital, Kolkata 
Address  Room No. 110, OPD Building, Dept. of Physical Medicine and Rehabilitation, R. G. Kar Medical College and Hospital 1, Khudiram Bose Sarani, Kolkata Kolkata WEST BENGAL 700004 India

Kolkata
WEST BENGAL
700004
India 
Phone  9062538354  
Fax    
Email  ribhubhattacharya13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Pankaj Kumar Mandal 
Designation  Professor an Head, Department of PMR, RGKMCH 
Affiliation  R. G. Kar Medical College and Hospital, Kolkata 
Address  Dept. of Physical Medicine and Rehabilitation, R. G. Kar Medical College and Hospital 1, Khudiram Bose Sarani, Kolkata Kolkata WEST BENGAL 700004 India

Kolkata
WEST BENGAL
700004
India 
Phone  9433915696  
Fax    
Email  rehabyouall@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ribhu Bhattacharya 
Designation  Post Graduate Trainee 
Affiliation  R. G. Kar Medical College and Hospital, Kolkata 
Address  Room No. 110, OPD Building, Dept. of Physical Medicine and Rehabilitation, R. G. Kar Medical College and Hospital 1, Khudiram Bose Sarani, Kolkata Kolkata WEST BENGAL 700004 India


WEST BENGAL
700004
India 
Phone  9062538354  
Fax    
Email  ribhubhattacharya13@gmail.com  
 
Source of Monetary or Material Support  
R. G. Kar Medical College, 1, Khudiram Bose Sarani, Kolkata- 700004, West Bengal, India 
 
Primary Sponsor  
Name  R. G. Kar Medical College, Kolkata 
Address  1, Khudiram Bose Sarani, Kolkata- 700004 
Type of Sponsor  Government medical college 
 
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 
Ribhu Bhattacharya  R. G. Kar Medical College and Hospital  Department of Physical Medicine and Rehabilitation, Room No. 110, Ground Floor, OPD Building R. G. Kar Medical College, 1, Khudiram Bose Sarani Kolkata WEST BENGAL
Kolkata
WEST BENGAL 
9062538354

ribhubhattacharya13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, R. G. Kar Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M771||Lateral epicondylitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low-level Laser Therapy (LLLT)  LLLT group will receive treatment with low-level laser for 10 minutes in five days per week for two weeks plus a hot pack, for ten sessions 
Comparator Agent  Ultrasound Therapy (UST)  Patients in the ultrasound group will receive continuous mode US at a frequency of 1 MHz and intensity of 0.8 W/cm2 for 5 minutes in five days per week for two weeks plus a hot pack on the lateral elbow region, for ten sessions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of lateral epicondylitis.
Unilateral involvement.
Symptom duration more than 3 months but less than 12 months. 
 
ExclusionCriteria 
Details  • Bilateral lateral epicondylitis.
• Elbow arthritis or bursitis.
• Posterior interosseous neuropathy (PIN)
• Acute trauma or fracture at elbow or surrounding area.
• History of local corticosteroid or local anaesthetic injection in the last six months and prior physiotherapy for lateral epicondylitis in the past.
• Prior elbow surgery.
• Presence of systemic diseases (e.g., diabetes mellitus, thyroid disorders, rheumatoid arthritis).
• Patients with cervical radiculopathy or any musculoskeletal disorders affecting the upper limb.
• Chronic inflammatory and neoplastic disease.
• Pregnancy.
• Patients with implanted pacemaker.
• Patient’s refusal.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the reduction in pain severity in patients receiving LLLT and UST using Visual Analog Scale (VAS).   Day 0, week 2, week 6, week 14, week 26 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the improvement in grip strength in both treatment groups using hand dynamometer.   Day 0, week 2, week 6, week 14, week 26 
To evaluate functional improvement and patient-reported outcomes using Patient rated tennis elbow evaluation (PRTEE).  Day 0, week 2, week 6, week 14, week 26 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 2/ Phase 3 
Date of First Enrollment (India)   02/03/2026 
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="1"
Months="6"
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  

This study aims to compare the long-term effectiveness of Low-Level Laser Therapy (LLLT) and Ultrasound Therapy (UST) in the management of lateral epicondylitis among patients attending the Physical Medicine and Rehabilitation OPD of R G Kar Medical College and Hospital, Kolkata. Lateral epicondylitis, a common overuse injury affecting the extensor tendon origin, results in significant pain, functional limitation, and reduced grip strength. Although modalities such as LLLT and UST are routinely used in rehabilitation settings, existing literature offers conflicting evidence regarding their comparative efficacy, and real-world observational data—especially from India—are limited. This study intends to address this gap by evaluating clinical outcomes using validated tools such as the Visual Analog Scale (VAS), Patient-Rated Tennis Elbow Evaluation (PRTEE), and hand-held dynamometry.

The research is designed as a prospective interventional study involving 54 participants randomized into LLLT and UST groups. Both groups will receive standardized treatment protocols, including hot packs, counterforce bracing, and prescribed wrist extensor exercises. Outcomes will be assessed at baseline, two weeks, one month, three months, and six months to determine changes in pain, functional capacity, and grip strength. Ethical approval will be obtained prior to study initiation, and all participants will provide informed consent. Data will be analysed using appropriate statistical methods, including t-tests and repeated-measures ANOVA.

It is expected that both LLLT and UST will provide pain relief and functional improvement, but LLLT may offer superior long-term benefits. The findings will support evidence-based decision-making and help optimize non-invasive treatment strategies for lateral epicondylitis in routine clinical practice.

 
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