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| Name | Class |
|---|---|
| Universiti Kebangsaan Malaysia Medical Centre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Participants in this arm will receive active High-Intensity Laser Therapy applied to the trapezius muscle region for the treatment of trapezius myofascial pain syndrome. |
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| Sham Laser Therapy | Placebo Comparator | Participants in this arm will receive sham laser therapy applied to the trapezius muscle region. The sham procedure will mimic the appearance and application of active laser therapy without delivering therapeutic laser energy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Laser Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity will be evaluated using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. | 16-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Disability | Neck Disability Index (NDI) | 16-week follow-up |
| Cervical Range of Motion | Measured using CROM device | 16-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Hussein Teaching Hospital | Nasiriyah | Nasiriyah | 64001 | Iraq |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Sham Laser Therapy | Device | 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. |
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| Depression | Beck Depression Inventory-II (BDI-II) | 16-week follow-up |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |