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Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial

Sponsor
Mohamed Abdelmoneim El Meligy (Other)
Overall Status
Recruiting
CT.gov ID
NCT05504382
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: naproxen phonophoresis
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Clinical TrialRandomized Clinical Trial
Masking:
Single (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
Primary Purpose:
Treatment
Official Title:
Effect of Electroacupuncture Versus Phonophoresis on Refractory Pain in Juvenile Rheumatoid Arthritis
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group 1

receive especially electrical acupuncture on the knee joint

Device: naproxen phonophoresis
transmission of naproxen molecule by therapeutic ultrasound
Other Names:
  • electroacupuncture

    		•
    Experimental: study group 2

    receive naproxen phonophoresis on the knee joint

    Device: naproxen phonophoresis
    transmission of naproxen molecule by therapeutic ultrasound
    Other Names:
  • electroacupuncture

    		•

    Outcome Measures

    Primary Outcome Measures

    1. knee pain [2 weeks]

      change in refractory knee pain will be assessed by visual analogue scale

    Secondary Outcome Measures

    1. knee joint range of motion [2 weeks]

      change in the range of motion of knee joint will be measured by universal goniometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt 12613

    Sponsors and Collaborators

    • Mohamed Abdelmoneim El Meligy

    Investigators

    • Principal Investigator: Mohamed Abo-El-Ros, Ph.d, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Abdelmoneim El Meligy, DR. Mohamed Abdelmoeim Ahmed Abo-El-Ros, Egyptian Chinese University
    ClinicalTrials.gov Identifier:
    NCT05504382
    Other Study ID Numbers:
    • P.T.REC/012/003788
    First Posted:
    Aug 17, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Mohamed Abdelmoneim El Meligy, DR. Mohamed Abdelmoeim Ahmed Abo-El-Ros, Egyptian Chinese University
    Refractory Pain Juvenile Rheumatoid Arthritis
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Arthritis, Juvenile
    Pain, Intractable
    Naproxen

    Study Results

    No Results Posted as of Aug 17, 2022