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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04185194
Other study ID # P.T.REC/012/001708
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 1, 2019
Est. completion date March 1, 2019

Study information

Verified date December 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 10 Years to 14 Years
Eligibility 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.

Study Design


Intervention

Drug:
Lidocaine
transmission of the drug molecules to the underlying muscles
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

Locations

Country Name City State
Egypt faculty of physical therapy,Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary interleukin 6 measurement of interleukin 6 cncentration in blood plasma three months
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