Myofascial Pain Syndrome (MPS)
Conditions
Keywords
High-Intensity Laser Therapy, Trapezius Myofascial Pain Syndrome, Randomized Controlled Trial, Neck Pain, Physiotherapy
Brief summary
This study aims to evaluate the effectiveness of optimized High-Intensity Laser Therapy (HILT) compared with sham treatment in patients with trapezius myofascial pain syndrome. Outcomes include pain intensity, cervical range of motion, functional disability, and depressive symptoms measured at baseline, post-intervention, and 16-week follow-up.
Detailed description
Myofascial pain syndrome of the trapezius muscle is a common cause of chronic neck and shoulder pain associated with functional limitation and psychological distress. Although High-Intensity Laser Therapy is increasingly used in clinical practice, high-quality evidence regarding its long-term effects and optimal treatment parameters is limited. This double-blind, randomized, placebo-controlled trial will enroll 104 adults with clinically diagnosed trapezius myofascial pain syndrome. Participants will be randomly assigned to receive either optimized High-Intensity Laser Therapy or sham laser treatment. Outcomes will be assessed at baseline, immediately after the intervention, and at 16-week follow-up. This study aims to provide evidence for a standardized, patient-centered HILT protocol suitable for routine clinical practice.
Interventions
High-Intensity Laser Therapy will be administered using a class IV therapeutic laser device applied over identified trapezius myofascial trigger points and surrounding muscle tissue. Treatment parameters (wavelength, power output, energy density, and duration) will follow standardized clinical protocols and safety guidelines. Sessions will be delivered by a licensed physical therapist, with participants receiving multiple treatment sessions over the intervention period. The therapy aims to promote analgesia, improve microcirculation, reduce muscle tension, and facilitate tissue healing.
DEVICESham Laser Therapy
Sham laser therapy will be administered using an identical laser device and treatment procedure; however, no therapeutic laser energy will be emitted. The duration, frequency, and therapist interaction will be identical to the active treatment.
Sponsors
Neveen Abd El Maksoad Kohaf
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years * Clinically diagnosed trapezius myofascial pain syndrome * Duration of symptoms ≥ 4 weeks * Pain intensity ≥ 4 on NPRS * Able to provide informed consent
Exclusion criteria
* Red-flag medical conditions (e.g., malignancy, spinal cord compression) * Neurological disorders affecting the neck or shoulder * Cognitive impairment or inability to communicate * Previous laser therapy to the neck/shoulder region within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 16-week follow-up | Pain intensity will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability | 16-week follow-up | Neck Disability Index (NDI) |
| Cervical Range of Motion | 16-week follow-up | Measured using CROM device |
| Depression | 16-week follow-up | Beck Depression Inventory-II (BDI-II) |
Countries
Iraq
Outcome results
None listed