Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial
Primary Purpose
Juvenile Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
naproxen phonophoresis
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Rheumatoid Arthritis focused on measuring Refractory Pain Juvenile Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
• Age ranges from 14 to 16 years.
- All children will be assigned to the study are suffering from persistent oligoarthritis.
- All children have regional knee pain complaint more than 6 weeks.
- Pain and stiffness especially in the morning, and a joint that feels warm to the touch
- Low grade fever at the onset of disease
Exclusion Criteria:
• Neurological disorders.
- Dermatological disorders.
- Acute trauma prior to the study.
- Other co- morbidities like diabetes and conditions associated with inflammation such as malegnancies.
- Analgesic drugs or NSAIDs during the treatment period.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group 1
study group 2
Arm Description
receive especially electrical acupuncture on the knee joint
receive naproxen phonophoresis on the knee joint
Outcomes
Primary Outcome Measures
knee pain
change in refractory knee pain will be assessed by visual analogue scale
Secondary Outcome Measures
knee joint range of motion
change in the range of motion of knee joint will be measured by universal goniometer
Full Information
NCT ID
NCT05504382
First Posted
August 13, 2022
Last Updated
August 15, 2022
Sponsor
Mohamed Abdelmoneim El Meligy
1. Study Identification
Unique Protocol Identification Number
NCT05504382
Brief Title
Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial
Official Title
Effect of Electroacupuncture Versus Phonophoresis on Refractory Pain in Juvenile Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Abdelmoneim El Meligy
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the purpose of the study is to investigate the effect of Electrical Acupuncture Versus naproxen phonophoresis on Refractory pain in Juvenile Rheumatoid arthritis
Detailed Description
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children and adolescents, affecting approximately one in 1000 children in North America. It is diagnosed in children younger than 16 years of age with arthritis in one or more joints for at least six weeks after other causes have been excluded. Arthritis in JIA is characterized by stiffness, pain and swelling of affected joints. The disease course of JIA may involve flares of increased disease activity or chronic persistent joint inflammation, even into adulthood. Various complications may arise secondary to ongoing disease activity or treatment, including joint damage and deformity, growth abnormalities and osteoporosis with fragility fractures The prevalence of refractory pain in children with arthritis is of particular concern because it often contributes to poor physical and psychosocial outcomes. Increased daily symptoms of pain predict considerable functional disability, including significantly reduced participation in school, social and physical activities, and augmented mood disturbance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Rheumatoid Arthritis
Keywords
Refractory Pain Juvenile Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
Participant
Masking Description
children suffering from juvenile idiopathic arthritis/oligoarthritic (mainly the knee joint) will participate in the study.
All children will be randomly assigned into 2 groups of equal numbers A, B using sealed envelopes, 21 children for each group.
Study group A: will receive especially electrical acupuncture on the knee joint
Study group B: will receive naproxen phonophoresis on the knee joint
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group 1
Arm Type
Experimental
Arm Description
receive especially electrical acupuncture on the knee joint
Arm Title
study group 2
Arm Type
Experimental
Arm Description
receive naproxen phonophoresis on the knee joint
Intervention Type
Device
Intervention Name(s)
naproxen phonophoresis
Other Intervention Name(s)
electroacupuncture
Intervention Description
transmission of naproxen molecule by therapeutic ultrasound
Primary Outcome Measure Information:
Title
knee pain
Description
change in refractory knee pain will be assessed by visual analogue scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
knee joint range of motion
Description
change in the range of motion of knee joint will be measured by universal goniometer
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Age ranges from 14 to 16 years.
All children will be assigned to the study are suffering from persistent oligoarthritis.
All children have regional knee pain complaint more than 6 weeks.
Pain and stiffness especially in the morning, and a joint that feels warm to the touch
Low grade fever at the onset of disease
Exclusion Criteria:
• Neurological disorders.
Dermatological disorders.
Acute trauma prior to the study.
Other co- morbidities like diabetes and conditions associated with inflammation such as malegnancies.
Analgesic drugs or NSAIDs during the treatment period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Anwar, Ph.D
Phone
+201002538439
Email
Aalaa.anwar222@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Fayez, Ph.D
Phone
+201222748287
Email
mfayez@ecu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abo-El-Ros, Ph.d
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El Nahas, Ph.D
Phone
+201224134043
Email
aelnahhas@horus.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial
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