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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04185194

Collaborator

(none)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

25.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Side Effects	Drug: Lidocaine Device: pulsed ultrasound Other: especially designed physical therapy program	Phase 1

Detailed Description

Fourty five children (athletic swimmers) participated in this study, and were classified into three groups ; First control group A : this group consisted of fifteen children were receiving traditional physical therapy program. Second study group B: this group consisted of fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy program as the same as in group A. Third study group C: this group consisted of fifteen children were receiving lidocaine phonophoresis in addition to traditional physical therapy program as the same as in group A. Treatment program in the three groups applied three times a week for three successive months. The study was done in the outpatient clinic of Ismailiy Sporting Club, Ismailia, Egypt.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized control trialrandomized control trial

Masking:

Single (Participant)

Masking Description:

sealed envelopes

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A received especially designed physical therapy program	Other: especially designed physical therapy program by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius
Experimental: group b received pulsed ultrasound in addition to physical therapy program	Drug: Lidocaine transmission of the drug molecules to the underlying muscles Other Names: lidocaine topical Device: pulsed ultrasound using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain Other: especially designed physical therapy program by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius
Experimental: group c received lidocaine phonophoresis in addition to physical therapy program	Drug: Lidocaine transmission of the drug molecules to the underlying muscles Other Names: lidocaine topical Device: pulsed ultrasound using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain Other: especially designed physical therapy program by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius

Arm

Intervention/Treatment

Active Comparator: group A

received especially designed physical therapy program

Other: especially designed physical therapy program

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

Experimental: group b

received pulsed ultrasound in addition to physical therapy program

Drug: Lidocaine

transmission of the drug molecules to the underlying muscles

Other Names:

lidocaine topical

Device: pulsed ultrasound

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

Other: especially designed physical therapy program

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

Experimental: group c

received lidocaine phonophoresis in addition to physical therapy program

Drug: Lidocaine

transmission of the drug molecules to the underlying muscles

Other Names:

lidocaine topical

Device: pulsed ultrasound

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

Other: especially designed physical therapy program

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

Outcome Measures

Primary Outcome Measures

interleukin 6 [three months]
measurement of interleukin 6 cncentration in blood plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of physical therapy,Cairo University	Giza		Egypt	12612

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Asser Sallam, PhD, Suez Canal University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed abdel Moneim Abo El Roos, pediatric physical therapy specialist (master degree), Cairo University

ClinicalTrials.gov Identifier:

NCT04185194

Other Study ID Numbers:

P.T.REC/012/001708

First Posted:

Dec 4, 2019

Last Update Posted:

Dec 4, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mohamed abdel Moneim Abo El Roos, pediatric physical therapy specialist (master degree), Cairo University

myofascial pain syndrome, pain quality

Additional relevant MeSH terms:

Myofascial Pain Syndromes

Fibromyalgia

Lidocaine

Study Results

No Results Posted as of Dec 4, 2019