Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis (MPS)

August 23, 2024 updated by: Mohamed Abdel Moeim Abo EL Ros, New Ismailia National University

Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty five males athletic swimmer children (10 to 14 years old) with MPS in the upper trapezius muscle were evaluated before and after treatment. They were randomly divided into three groups, n=15 children each. A (control), B and C (study groups). The three groups received spatial designed physical therapy program. The two study groups received pulsed ultrasound and lidocaine phonophoresis repectively. The duration of treatment was 40 minutes, three times / weeks for three successive months.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt, 41522
        • College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group A
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
manual massage and range of motion exercises
Other Names:
  • myofascial trigger point realease
Experimental: study group B
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
Other: myofascial release
manual massage and range of motion exercises
Other Names:
  • myofascial trigger point realease
Device: pulsed ultrasound
treatment of myofacial trigger points with therapeutic ultrasound
Experimental: study group C
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 release
manual massage and range of motion exercises
Other Names:
  • myofascial trigger point realease
Device: lidocaine phonophoresis
transdermal tranmission of lidocaine molecules via ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain quality
Time Frame: 6 weeks
pain quality assessment scale with zero indication of better outcome and twenty means the worst outcome
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum cortisol level
Time Frame: 6 weeks
measurement of serum cortisol level
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Ismailia National University

Investigators

  • Study Chair: Mohamed AM El Meligy, MD, Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Actual)

May 10, 2024

Study Completion (Actual)

July 29, 2024

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/001708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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