NCT06573775

Brief Summary

To evaluate pain quality by pain quality assessment scale (PQAS) using lidocaine phonophoresis on myofascial pain syndrome (MPS) in athletic children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 5, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 19, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

Myofascialphonophoresispain

Outcome Measures

Primary Outcomes (1)

  • pain quality

    pain quality assessment scale with zero indication of better outcome and twenty means the worst outcome

    6 weeks

Secondary Outcomes (1)

  • serum cortisol level

    6 weeks

Study Arms (3)

control group A

ACTIVE COMPARATOR

the control group received the traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release, stretching and strengthening of the trapezius muscle

Other: myofascial release

study group B

EXPERIMENTAL

received pulsed ultrasound in addition to traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release, range of motion exercises, stretching and strengthening of the trapezius muscle

Device: pulsed ultrasoundOther: myofascial release

study group C

EXPERIMENTAL

received lidocaine hydrochloride gel 5%phonophoresis in addition to traditional physical therapy for treating myofascial trigger points in the form of a myofascial trigger point release,range of motion exercises stretching and strengthening of the trapezius muscle

Other: myofascial releaseDevice: lidocaine phonophoresis

Interventions

treatment of myofacial trigger points with therapeutic ultrasound

study group B

manual massage and range of motion exercises

Also known as: myofascial trigger point realease
control group Astudy group Bstudy group C

transdermal tranmission of lidocaine molecules via ultrasound

study group C

Eligibility Criteria

Age10 Years - 14 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadolescents
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age range from 10 to 14 years.
  • All children have regional neck pain complaint.
  • Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I )
  • The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005):
  • Patients suffered from active MTrPs in the upper trapezius.
  • Tender spots in one or more palpable taut bands.
  • A typical pattern of referred pain distributed in the ipsilateral, posterolateral cervical paraspinal area, mastoid process or temporal area
  • Palpable or visible local twitch response on snapping palpation at the most sensitive spot in the taut band.
  • Restricted range of motion in lateral bending of the cervical spine to the opposite side.
  • Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle.
  • Identification of a palpable taut band, as well as a palpable, and exquisitely tender spot along the length of that taut band.
  • All children allowed to practice their regular sport activities.

You may not qualify if:

  • Neurological disorders.
  • Dermatological disorders.
  • Acute trauma prior to the study.
  • Fibromyalgia, systemic disease and drug allergy history were excluded from the study.
  • Having myofascial trigger points injection.
  • Chronic pain in both sides of the body.
  • History of findings of cervical injury whether orthopedic or soft tissue injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine

Ismailia, 41522, Egypt

Location

MeSH Terms

Conditions

Neck PainPain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Mohamed AM El Meligy, MD

    Suez Canal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Pediatrics and its Surgeries

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 27, 2024

Study Start

June 5, 2023

Primary Completion

May 10, 2024

Study Completion

July 29, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations