| CTRI Number |
CTRI/2026/02/103141 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Low-Level Laser Therapy and Dry Needling in the Treatment of Myofascial Pain Syndrome |
|
Scientific Title of Study
|
A Comparative Study between Low-level Laser Therapy and Dry Needling in the Management of Myofascial Pain Syndrome in Patients 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 |
MKai Sian Khai Haokip |
| 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 |
7005033584 |
| Fax |
|
| Email |
khakhaihaokip@yahoo.co.uk |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head, Department of PMR, RGKMCH |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Dept. of PMR, R. G. Kar Medical College, 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 |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head, Department of PMR, RGKMCH |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Dept. of PMR, R. G. Kar Medical College, 1, Khudiram Bose Sarani,
Kolkata
Kolkata
WEST BENGAL
700004
India
Kolkata WEST BENGAL 700004 India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@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 |
| Dr M Kai Sian Khai Haokip |
R. G. Kar Medical College and Hospital |
Department of Physical
Medicine and
Rehabilitation, Room
No. 110, Ground Floor,
OPD Building
Kolkata
WEST BENGAL Kolkata WEST BENGAL |
7005033584
khakhaihaokip@yahoo.co.uk |
|
|
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: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dry Needling |
Day 0, Day 7, Day 14, Day 21 |
| Intervention |
Low-level Laser Therapy |
Day 0, Day 2, Day 5, Day 7, Day 9, Day 11, Day 14, Day 16, Day 18, Day 21, Day 23, Day 25 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of active trigger points in the cervical region, parascapular region up
to inferior angle of scapula up to T7 vertebral level.
Pain persisting for at least 3 months.
|
|
| ExclusionCriteria |
| Details |
Patients having diabetes mellitus.
Patients with systemic diseases affecting musculoskeletal function (e.g.,
rheumatoid arthritis, fibromyalgia).
History of trauma or surgery in the affected region.
Contraindications to laser therapy or dry needling (e.g., infection, malignancy,
pregnancy).
Use of other concurrent pain management treatments (e.g., steroid injections,
opioid therapy, physiotherapy).
Patients with implanted pacemaker.
Existing psychological issues. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of low-level laser therapy and dry
needling in reducing pain in patients with myofascial pain syndrome (MPS)
using Visual Analog Scale (VAS). |
Day 0, week 4, week 16, week 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of both treatments on general
health using the Nottingham Health Profile. |
Day 0, week 4, week 16, week 28 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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="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
|
This randomized controlled study aims to compare the effectiveness of Low-Level Laser Therapy (LLLT) and Dry Needling (DN) in reducing pain and improving functional outcomes in patients with Myofascial Pain Syndrome (MPS) attending a tertiary care hospital in Kolkata. MPS is a common musculoskeletal disorder characterized by myofascial trigger points, muscle stiffness, and localized or referred pain, frequently associated with poor posture, repetitive strain, and muscle overuse, leading to functional impairment and reduced quality of life. LLLT and DN are widely used non-pharmacological treatment modalities for MPS; LLLT acts through photobiomodulation to reduce inflammation and promote tissue healing, while DN alleviates pain by inactivating trigger points, reducing muscle tension, and improving local blood flow. However, direct comparative evidence between these interventions remains limited, particularly in the Indian population. A total of 50 patients with MPS will be enrolled and randomly allocated into two equal groups using block randomization. One group will receive LLLT three times per week, and the other group will undergo DN once weekly, for a duration of four weeks, along with standardized stretching exercises. Pain intensity, cervical range of motion, and general health status will be assessed using the Visual Analog Scale, goniometric measurements, and the Nottingham Health Profile at baseline, four weeks, three months, and six months. The study is expected to provide comparative evidence to assist clinicians in selecting effective and minimally invasive treatment options for the management of Myofascial Pain Syndrome. |