- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185194
Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children (PH)
December 1, 2019 updated by: Mohamed abdel Moneim Abo El Roos, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12612
- Faculty of Physical Therapy,Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: group A
received 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
|
by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius
transmission of the drug molecules to the underlying muscles
Other Names:
using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain
|
EXPERIMENTAL: group c
received lidocaine phonophoresis in addition to 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
transmission of the drug molecules to the underlying muscles
Other Names:
using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
interleukin 6
Time Frame: three months
|
measurement of interleukin 6 cncentration in blood plasma
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Asser Sallam, PhD, Suez Canal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2019
Primary Completion (ACTUAL)
January 1, 2019
Study Completion (ACTUAL)
March 1, 2019
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
December 1, 2019
First Posted (ACTUAL)
December 4, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 4, 2019
Last Update Submitted That Met QC Criteria
December 1, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- P.T.REC/012/001708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
results of the study design, abstract, conclusion
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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