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Not Yet RecruitingNCT07137728

Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius

A Randomized Controlled Trial to Evaluate the Effect of Dual Frequency Low-Level Laser Therapy on Pain Intensity, Pressure Pain Threshold, and Functional Outcomes in Patients With Myofascial Trigger Points in the Upper Trapezius Muscle

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
University of Lahore · Academic / Other
Sex
All
Age
20 Years – 55 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial is to learn if dual frequency low-level laser therapy (DF-LLLT) works to reduce pain and improve neck function in adults with myofascial trigger points in the upper trapezius muscle. It will also determine whether DF-LLLT improves cervical range of motion. The main questions it aims to answer are: i)Does DF-LLLT reduce pain intensity on the Visual Analog Scale (VAS) more than sham laser therapy? ii)Does DF-LLLT improve functional status (Neck Disability Index) and cervical range of motion more than sham laser therapy? Researchers will compare DF-LLLT plus conventional therapy to sham laser plus conventional therapy to see if DF-LLLT has greater therapeutic effects. Participants will: 1. Receive either DF-LLLT or sham laser therapy twice weekly for 4 weeks 2. Perform a standardized stretching and strengthening exercise program for the neck and shoulders. 3. Attend clinic visits at baseline, week 2, and week 4 for assessments of pain, function, and cervical mobility.

Detailed description

Myofascial trigger points (MTrPs) in the upper trapezius muscle are a frequent source of neck pain, muscle stiffness, and reduced cervical mobility. They are characterized by hypersensitive palpable nodules within taut muscle fibers that can produce local and referred pain. Traditional management strategies include stretching, strengthening, and various physical therapy modalities, but recurrence and incomplete relief are common. Low-level laser therapy (LLLT) is a non-invasive photobiomodulation technique shown to reduce pain and inflammation and promote tissue healing. Dual frequency LLLT may provide enhanced therapeutic effects compared to single frequency LLLT by delivering both continuous and pulsed light energy to targeted tissues. However, clinical evidence for its use in upper trapezius MTrPs is limited. This single-blinded randomized controlled trial will recruit 32 male and female participants aged 20-55 years who meet the diagnostic criteria for MTrPs according to Simons' guidelines. Participants will be randomly assigned to one of two groups: Experimental group: DF-LLLT (830 nm, 100 mW/cm², 9.12 Hz, 5 J/cm²) applied perpendicularly over each identified MTrP for 3 minutes 9 seconds per point, twice weekly for 4 weeks, plus a standardized stretching and strengthening program. Control group: Sham laser therapy with identical appearance and application time but without light emission, plus the same exercise program. Primary and secondary outcomes will be assessed at baseline, week 2, and week 4: Primary outcome: Change in pain intensity measured using the Visual Analog Scale (VAS) Secondary outcomes: Change in functional status (Neck Disability Index) and change in cervical range of motion (flexion, extension, lateral flexion, and rotation) measured with a goniometer. The study aims to determine whether DF-LLLT provides superior pain relief, functional improvement, and mobility gains compared to sham laser therapy when combined with conventional exercises. Statistical analysis will be performed using SPSS 21.0, with significance set at p ≤ 0.05.

Conditions

Interventions

TypeNameDescription
DEVICEDual Frequency Low-Level Laser TherapyDF-LLLT (830 nm, 100 mW/cm², 9.12 Hz, 5 J/cm²) applied over each identified trigger point for 3 minutes 9 seconds per point, twice weekly for 4 weeks.
DEVICESham LaserInactive laser device identical in appearance and sound to the active laser but without light emission, applied for 3 minutes 9 seconds per point, twice weekly for 4 weeks.
OTHERConventional Therapy (Stretching and Strengthening Program)A standardized physiotherapy program including stretching and strengthening exercises for the cervical and shoulder muscles. The program is performed under physiotherapist supervision twice weekly for 4 weeks. Exercises are identical across both study arms and include stretching of the upper trapezius and strengthening of the neck and scapular stabilizer muscles.

Timeline

Start date
2025-08-25
Primary completion
2026-01-01
Completion
2026-02-01
First posted
2025-08-22
Last updated
2025-09-03

Source: ClinicalTrials.gov record NCT07137728. Inclusion in this directory is not an endorsement.

Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius (NCT07137728) · Clinical Trials Directory