Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children

NCT04185194 | Completed Phase 1 DMC

• 1 other identifier: P.T.REC/012/001708
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the anesthetic bases without concern about local irritation, uneven absorption or systemic toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers children.

Conditions

Treatment Side Effects

Keywords

myofascial pain syndrome, pain quality

Outcome Measures

Primary Outcomes (1)

• interleukin 6

  measurement of interleukin 6 cncentration in blood plasma

  three months

Study Arms (3)

group A

ACTIVE COMPARATOR

received especially designed physical therapy program

Other: especially designed physical therapy program

group b

EXPERIMENTAL

received pulsed ultrasound in addition to physical therapy program

Drug: Lidocaine; Device: pulsed ultrasound; Other: especially designed physical therapy program

group c

EXPERIMENTAL

received lidocaine phonophoresis in addition to physical therapy program

Drug: Lidocaine; Device: pulsed ultrasound; Other: especially designed physical therapy program

Interventions

Lidocaine DRUG

transmission of the drug molecules to the underlying muscles

Also known as: lidocaine topical

group b; group c

pulsed ultrasound DEVICE

using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain

group b; group c

especially designed physical therapy program OTHER

by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius

group A; group b; group c

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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)

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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy,Cairo University

Giza, 12612, Egypt

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Asser Sallam, PhD

  Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric physical therapy specialist (master degree)

Model Details: randomized control trial

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: December 4, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)