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Comparison Between High-Intensity Laser Therapy and Extracorporeal Shockwave Therapy in the Treatment of Myofascial Pain Syndrome

Comparison Between High-Intensity Laser Therapy and Extracorporeal Shockwave Therapy in the Treatment of Myofascial Pain Syndrome

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07176039
Enrollment
40
Registered
2025-09-16
Start date
2025-10-10
Completion date
2026-04-05
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome - Neck

Keywords

Myofascial Pain Syndrome, High-Intensity Laser Therapy, Extracorporeal Shockwave Therapy, Cervical Pain, Physical Therapy, Pain Management

Brief summary

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.

Detailed description

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: * HILT Group: Class IV pulsed Nd:YAG laser (1064 nm), peak power 3000 W, average power 10 W, frequency 1000 Hz, energy density 12-15 J/cm² per trigger point, 3 sessions/week × 4 weeks (12 total sessions). * ESWT Group: Radial extracorporeal shockwave therapy, energy flux density 0.08-0.12 mJ/mm², frequency 8-10 Hz, \ 1500 pulses/session, 1 session/week × 4 weeks (4 total sessions). 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.

Interventions

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.

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).

Sponsors

MTI University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating Scale for Pain IntensityBaseline and 4 weeks after intervention (post-treatment)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. \[Time Frame: Baseline and 4 weeks post-intervention\]

Secondary

MeasureTime frameDescription
Pressure Pain Threshold (PPT) as measured by pressure algometerBaseline and 4 weeks post-treatmentThe 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.
Neck Disability Index (NDI)Baseline and 4 weeks post-treatmentFunctional 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.
Cervical Range of Motion (ROM)Baseline, 4 weeks

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORreda K. Abdelrazik, associate professor

Benha University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026