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

NCT ID: NCT06990932

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-04-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High Intensity Laser

this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month

Group Type: EXPERIMENTAL

High Intensity Laser

Intervention Type: DEVICE

The therapeutic dose of laser therapy depends on power density, tissue color, and type. Darker skin may absorb the laser in the epidermal layer, but HILT can pass through without absorption. Research has improved power density and dose, with the World Association of Laser Therapy recommending a 5-7 J/cm2 dose for optimal therapeutic outcomes.

Conventional treatment

Intervention Type: OTHER

conventional physical therapy, which includes ultrasound, isometric neck exercises, chin tucks, stretching of neck muscles, and neck stabilization exercises, were used for groups A, B and C

Instrument-assisted soft tissue mobilization

this group consists of 20 subjects will receive conventional treatment combined with Instrument-assisted soft tissue mobilization, three times per week for one month

Group Type: ACTIVE_COMPARATOR

Instrument-assisted Soft Tissue Mobilization

Intervention Type: OTHER

Instrument-assisted soft tissue mobilization is a popular alternative to traditional manual therapy techniques, derived from Cyriax cross-friction massage. It uses hard tools to manipulate soft tissue, varying in direction, force, and pattern, and allowing pressure to disperse to underlying tissues. Modern Instrument-assisted soft tissue mobilization instruments vary in material and design, and are used to improve musculoskeletal conditions and outcomes. Patients receive Instrument-assisted soft tissue mobilization with an M2T blade, positioned at a 45° angle, and instructed to apply an ice pack if experiencing burning sensations.

Conventional treatment

Intervention Type: OTHER

conventional physical therapy, which includes ultrasound, isometric neck exercises, chin tucks, stretching of neck muscles, and neck stabilization exercises, were used for groups A, B and C

conventional treatment

this group consists of 20 subjects will receive conventional treatment only, three times per week for one month

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

conventional physical therapy, which includes ultrasound, isometric neck exercises, chin tucks, stretching of neck muscles, and neck stabilization exercises, were used for groups A, B and C

Interventions

High Intensity Laser

The therapeutic dose of laser therapy depends on power density, tissue color, and type. Darker skin may absorb the laser in the epidermal layer, but HILT can pass through without absorption. Research has improved power density and dose, with the World Association of Laser Therapy recommending a 5-7 J/cm2 dose for optimal therapeutic outcomes.

Intervention Type: DEVICE

Instrument-assisted Soft Tissue Mobilization

Instrument-assisted soft tissue mobilization is a popular alternative to traditional manual therapy techniques, derived from Cyriax cross-friction massage. It uses hard tools to manipulate soft tissue, varying in direction, force, and pattern, and allowing pressure to disperse to underlying tissues. Modern Instrument-assisted soft tissue mobilization instruments vary in material and design, and are used to improve musculoskeletal conditions and outcomes. Patients receive Instrument-assisted soft tissue mobilization with an M2T blade, positioned at a 45° angle, and instructed to apply an ice pack if experiencing burning sensations.

Intervention Type: OTHER

Conventional treatment

conventional physical therapy, which includes ultrasound, isometric neck exercises, chin tucks, stretching of neck muscles, and neck stabilization exercises, were used for groups A, B and C

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Adel Ahmed Abdelmoaty AboHashish

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

outpatient clinic of faculty of physical therapy Benha National university

Banhā, , Egypt

Countries

Egypt

Other Identifiers

Ahmed-005701

Identifier Type: -

Identifier Source: org_study_id