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

Primary Purpose

Treatment Side Effects

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Lidocaine

pulsed ultrasound

especially designed physical therapy program

About this trial

This is an interventional treatment trial for Treatment Side Effects focused on measuring myofascial pain syndrome, pain quality

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept 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.

Sites / Locations

faculty of physical therapy,Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

group A

group b

group c

Arm Description

received especially designed physical therapy program

received pulsed ultrasound in addition to physical therapy program

received lidocaine phonophoresis in addition to physical therapy program

Outcomes

Primary Outcome Measures

interleukin 6

measurement of interleukin 6 cncentration in blood plasma

Secondary Outcome Measures

Full Information

NCT ID

NCT04185194

First Posted

November 15, 2019

Last Updated

December 1, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04185194

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Side Effects

Keywords

myofascial pain syndrome, pain quality

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

randomized control trial

Masking

Participant

Masking Description

sealed envelopes

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

received especially designed physical therapy program

Arm Title

group b

Arm Type

Experimental

Arm Description

received pulsed ultrasound in addition to physical therapy program

Arm Title

group c

Arm Type

Experimental

Arm Description

received lidocaine phonophoresis in addition to physical therapy program

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

lidocaine topical

Intervention Description

transmission of the drug molecules to the underlying muscles

Intervention Type

Device

Intervention Name(s)

pulsed ultrasound

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

especially designed physical therapy program

Intervention Description

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

Primary Outcome Measure Information:

Title

interleukin 6

Description

measurement of interleukin 6 cncentration in blood plasma

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asser Sallam, PhD

Organizational Affiliation

Suez Canal University

Official's Role

Study Director

Facility Information:

Facility Name

faculty of physical therapy,Cairo University

City

Giza

ZIP/Postal Code

12612

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

results of the study design, abstract, conclusion

Learn more about this trial

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

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