| 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
|
|
|
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
|
|
|
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. |