CClinicalTrials.gg
CompletedNCT06573775MPSUpdated Aug 27, 2024

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

An interventional study of pulsed ultrasound and myofascial release in Neck Pain, sponsored by New Ismailia National University. Completed at 1 site in Egypt. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by New Ismailia National University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
10 Years to 14 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Neck Pain

Keywords

  • Myofascial
  • phonophoresis
  • pain
03

In context

Myofascial Pain Syndromes

1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

New Ismailia National University is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
45 participants (actual)

Study arms

  • 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

  • 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

    Device: pulsed ultrasound · Other: myofascial release

  • 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 · Device: lidocaine phonophoresis

Interventions

  • Devicepulsed ultrasound

    treatment of myofacial trigger points with therapeutic ultrasound

  • Othermyofascial release

    manual massage and range of motion exercises

    Also known as: myofascial trigger point realease

  • Devicelidocaine phonophoresis

    transdermal tranmission of lidocaine molecules via ultrasound

06

What researchers measure

Primary outcomes

  1. pain quality

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

    Time frame: 6 weeks

Secondary outcomes

  1. serum cortisol level

    measurement of serum cortisol level

    Time frame: 6 weeks

07

Study locations

1 site
  • College of Medicine
    Ismailia, 41522, Egypt
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Aug 1, 2024
  • Informed consent form · Aug 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06573775
Lead sponsor
New Ismailia National University
Responsible party
Mohamed Abdel Moeim Abo EL Ros (Lecturer of Physical Therapy for Pediatrics and its Surgeries, New Ismailia National University) — Principal investigator
First posted
Aug 27, 2024
Start date
Jun 5, 2023
Primary completion
May 10, 2024
Completion
Jul 29, 2024
Last update
Aug 27, 2024

Study contacts

Mohamed AM El Meligy, MD
study chair · Suez Canal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion