High Intensity Laser vs Instrument-assisted Soft Tissue Mobilization on Trapezius Myofascial Pain Syndrome

Not Applicable

Completed

• Conditions: High Intensity Laser; Instrument Assisted Soft Tissue Mobilization; Trapezius Muscle Strain; Myofascial Pain Syndrome

• Registration Number: NCT06990932
• Lead Sponsor: Cairo University

Brief Summary

The purpose of the study was to

1. Investigate the effect of high-intensity laser therapy versus Instrument-assisted soft tissue mobilization on pain level in patients with myofascial pain syndrome of upper trapezius muscle.

2. Investigate the effect of High intensity laser therapy versus Instrument-assisted soft tissue mobilization on ROM in patients with myofascial pain syndrome of upper trapezius muscle

Detailed Description

Myofascial pain syndrome is a common musculoskeletal pain affecting 30% of patients in primary care. It is characterized by trigger points in the upper trapezius muscle, which is linked to neck and shoulder pain. Non-invasive treatments like exercises, manipulation, and physical agents have been suggested for managing neck pain. Laser therapy, including low-level and high-intensity, has been found effective in reducing pain intensity and improving functional activity. Instrument-assisted soft tissue mobilization is another technique used to treat Myofascial pain syndrome. Instrument-assisted soft tissue mobilization stimulates connective tissue remodeling, resorbing excessive fibrosis, and promoting collagen repair and regeneration. The study aims to investigate the effect of high intensity laser therapy versus Instrument-assisted soft tissue mobilization in treating Myofascial pain syndrome of the upper trapezius muscle.

Study Timeline

• Study Start: 2025-02-01
• Primary Completion: 2025-03-15
• Study Completion: 2025-04-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. The patient age ranged from 20 to 50 years
2. Presence of myofascial trigger points in the upper trapezius muscle
3. Having neck discomfort symptoms that were triggered by certain neck positions and by palpating the cervical musculature for at least three months
4. Patient willing and able to participate in an exercise program safely

Exclusion Criteria

1. medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis)
2. Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation.
3. If the patient had previous surgery in the neck area (irrespective of the reason for the operation)
4. Neck pain accompanied by vertigo caused by vertebra basilar insufficiency or accompanied by non-cervicogenic headaches

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of change of pain intensity	At baseline and after 1 month	The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice, especially for individuals over 18. Studies have shown moderate to strong correlations for VAS validity in pain measurement.

Secondary Outcome Measures

Name	Time	Method
Assessment of change of pressure pain threshold	At baseline and after 1 month	A pressure algometer is a reliable tool for determining local pressure pain threshold (PPT) in different pain syndromes. It is a force gauge calibrated in kg/cm2 and has a range of 0-10 kg/cm2. A manual pressure algometer will be used to measure pain threshold for upper trapezius fibers, with repeated measurements to improve reliability.
Assessment of change of Cervical range of motion	At baseline and after 1 month	The CROM device is a lightweight, comfortable, and secure device that adjusts to a patient's head, resembling eyeglasses. It features two independent inclinometers, one in the sagittal and one in the frontal plane, and a third in the horizontal plane, indicating head rotation. The device is easy to use, requires minimal palpation, and is affordable compared to more advanced motion analysis systems.
Assessment of impact of neck pain on quality of life	At baseline and after 1 month	The Neck Bournemouth Questionnaire (NBQ) is a tool measuring neck pain's impact on daily activities and emotional well-being. It covers seven areas and scores 0 to 70, with higher scores indicating greater disability. The NBQ is sensitive and validated in English, French, Dutch, and Arabic.

Trial Locations

Locations (1)

outpatient clinic of faculty of physical therapy Benha National university; 🇪🇬 Banhā, Egypt