NCT06990932

Brief Summary

The purpose of the study was to

  1. 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

May 18, 2025

Last Update Submit

May 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of change of pain intensity

    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.

    At baseline and after 1 month

Secondary Outcomes (3)

  • Assessment of change of pressure pain threshold

    At baseline and after 1 month

  • Assessment of change of Cervical range of motion

    At baseline and after 1 month

  • Assessment of impact of neck pain on quality of life

    At baseline and after 1 month

Study Arms (3)

High Intensity Laser

EXPERIMENTAL

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

Device: High Intensity LaserOther: Conventional treatment

Instrument-assisted soft tissue mobilization

ACTIVE COMPARATOR

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

Other: Instrument-assisted Soft Tissue MobilizationOther: Conventional treatment

conventional treatment

ACTIVE COMPARATOR

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

Other: Conventional treatment

Interventions

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.

High Intensity Laser

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.

Instrument-assisted soft tissue mobilization

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

High Intensity LaserInstrument-assisted soft tissue mobilizationconventional treatment

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

outpatient clinic of faculty of physical therapy Benha National university

Banhā, Egypt

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

February 1, 2025

Primary Completion

March 15, 2025

Study Completion

April 1, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations