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This randomized single-blind controlled trial compares the effectiveness of High-Intensity Laser Therapy (HILT) versus Extracorporeal Shockwave Therapy (ESWT), both combined with standardized traditional physiotherapy, in patients with upper trapezius myofascial pain syndrome. Forty participants will be randomly assigned to receive either HILT (12 sessions over 4 weeks) or ESWT (4 sessions over 4 weeks). Primary outcome is pain intensity (NPRS); secondary outcomes include pressure pain threshold, neck disability index, and cervical range of motion.
This randomized single-blind controlled trial aims to compare the efficacy of High-Intensity Laser Therapy (HILT) and Extracorporeal Shockwave Therapy (ESWT) in managing patients with myofascial pain syndrome (MPS) of the upper trapezius/cervical region. Forty adults (20-45 years) diagnosed with MPS according to Travell and Simons' criteria will be randomly allocated (1:1) to either:
Both groups receive an identical standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization). Primary outcome: pain intensity (Numeric Pain Rating Scale). Secondary outcomes: pressure pain threshold (digital algometer), Neck Disability Index, and active cervical range of motion (CROM device). Assessments at baseline and week 4. The study is conducted at Faculty of Physical Therapy, Benha University, Egypt.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Participants will receive high-intensity laser therapy (HILT) using a Class IV pulsed Nd:YAG laser system (wavelength 1064 nm). Treatment parameters: peak power 3000 W, average power 10 W, frequency 1000 Hz (pulsed mode), energy density 12-15 J/cm² per trigger point, 4-6 active myofascial trigger points treated per session, total treatment duration 8-10 minutes per session. Treatment will be administered three times weekly for four weeks (total 12 sessions), combined with a standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization exercises). |
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| Extracorporeal Shockwave Therapy (ESWT) | Active Comparator | Participants will receive radial extracorporeal shockwave therapy (ESWT) using a pneumatic device (Gymna-Uniphy NV, Bilzen, Belgium). Treatment parameters: energy flux density 0.08-0.12 mJ/mm² (corresponding to device pressure setting 2.0-2.5 bar), frequency 8-10 Hz, approximately 1500 pulses per session delivered to active myofascial trigger points (500 pulses per trigger point). Treatment will be administered once weekly for four weeks (total 4 sessions), combined with a standardized traditional physiotherapy program (ischemic compression, stretching, scapular stabilization exercises).). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Laser Therapy (HILT) | Radiation | will be administered to active myofascial trigger points in the neck and shoulder region. The laser device used is an 808 nm gallium-aluminum-arsenide (GaAlAs) diode laser in continuous mode. Parameters: power output of 8-10 W, frequency of 2000 Hz, and application time of 60 seconds per trigger point, targeting 5-6 trigger points per session. Treatment will be delivered twice weekly for 4 consecutive weeks, totaling 8 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale for Pain Intensity | Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 = "no pain" and 10 = "worst imaginable pain". Assessments will be conducted at rest and during active cervical movement. The primary metric is the mean change in NPRS score from baseline to post-treatment (week 4). Lower scores indicate improvement. [Time Frame: Baseline and 4 weeks post-intervention] | Baseline and 4 weeks after intervention (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Threshold (PPT) as measured by pressure algometer | The pressure pain threshold (PPT) will be assessed using a digital pressure algometer (in kg/cm² or kPa) applied perpendicularly to active myofascial trigger points in the upper trapezius. The point at which the sensation changes from pressure to pain is recorded. Higher values indicate increased pain tolerance. Measurements will be taken at baseline and post-treatment. |
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Inclusion Criteria:
Male and female participants aged 18-60 years. Diagnosis of Myofascial Pain Syndrome (MPS) in the neck/shoulder region. Presence of active myofascial trigger points in the upper trapezius. Willingness to provide informed consent.
Exclusion Criteria:
History of cervical spine surgery, trauma, or radiculopathy. Contraindications to laser or shockwave therapy. Presence of systemic diseases (e.g., rheumatoid arthritis, malignancy). Receiving other physical therapy interventions during the study period
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| Name | Affiliation | Role |
|---|---|---|
| reda K. Abdelrazik, associate professor | Benha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Benha University | Cairo | Egypt |
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Single-blind (Outcome Assessor)
Masking Description:
Due to the physical nature of the interventions, blinding of treating therapists and participants was not feasible. However, outcome assessors and data analysts remained blinded to group allocation throughout the study. Participants were instructed not to disclose their treatment type during outcome assessments.
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| Extracorporeal Shockwave Therapy (ESWT) | Other | ESWT will be applied to active myofascial trigger points using a radial shockwave device. Parameters: Energy flux density 0.1-0.2 mJ/mm², 2000 shocks per session, frequency of 2 sessions per week for 4 weeks (8 sessions). |
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| Baseline and 4 weeks post-treatment |
| Neck Disability Index (NDI) | Functional disability will be assessed using the Neck Disability Index (NDI), a 10-item self-reported questionnaire scored from 0 to 50, where higher scores indicate greater disability. The primary metric is the mean change from baseline to post-treatment. | Baseline and 4 weeks post-treatment |
| Cervical Range of Motion (ROM) | Baseline, 4 weeks |
| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D019547 | Neck Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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