NCT06552780

Brief Summary

TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 19, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 10, 2024

Last Update Submit

August 15, 2024

Conditions

Keywords

"myofascial pain syndrome" "trigger points" "high intensity laser " "ischemic compression"

Outcome Measures

Primary Outcomes (1)

  • cervical range of motion (CROM)

    All the cervical active movements will be measured by cervical range of motion device (CROM) especially in cervical flexion ,extension and medial and lateral rotation.one tester will document the results. cervical range of motion (cROM) will be measured by using Electronic CROM Goniometer in all ranges.

    30 seconds

Secondary Outcomes (1)

  • cervical pain

    one minute

Other Outcomes (1)

  • pressure pain threshold (PPT)

    10 seconds

Study Arms (3)

high intensity laser , TENs and ultrasound and isometric exercise

EXPERIMENTAL

Group A ( study group )will receive high intensity laser ,TENs , ultrasound therapy , and isometric exercise.

Device: TENs , ultrasound therapy

ischemic compression ,TENs , ultrasound and isometric exercise

EXPERIMENTAL

Group B ( study group) will receive ischemic compression ,TENs and ultrasound therapy and isometric exercise.

Device: TENs , ultrasound therapy

TENs , ultrasound and isometric exercise

EXPERIMENTAL

Group C (control group ) will receive TENs and ultrasound therapy and isometric exercise only.

Device: TENs , ultrasound therapy

Interventions

effect of high intensity laser versus ischemic compression on myofascial trigger points in the upper trapezius

Also known as: high intensity (power) laser, ischemic compression, TENs , ultrasound therapy , isometric exercise and stretching exercise.
TENs , ultrasound and isometric exercisehigh intensity laser , TENs and ultrasound and isometric exerciseischemic compression ,TENs , ultrasound and isometric exercise

Eligibility Criteria

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

You may qualify if:

  • The age of patients range from 20 to 50 years .
  • patient Body mass index starting from 19 to 25 kg\\m.
  • presence of myofascial trigger points in the shortened upper trapezius muscle evaluated .

You may not qualify if:

  • patients with fibromyalgia syndrome.
  • cancer or tumor or any type diagnosed .
  • patients with disc herniation or spinal canal stenosis.
  • pregnancy -
  • patients diagnosed with epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve StimulationUltrasonic TherapyLasersAcupressure

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaDiathermyHyperthermia, InducedOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Officials

  • RAGIAA KAMEL, PROFFESOR DR

    RAGIAA M KAMEL , PROF DR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will be divided into three groups of equal number group A , group B ,and group C ,the randomization will be performed by computerized randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 14, 2024

Study Start

May 19, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations