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

Effect of Electroacupuncture Versus Phonophoresis on Refractory Pain in Juvenile Rheumatoid Arthritis

the purpose of the study is to investigate the effect of Electrical Acupuncture Versus naproxen phonophoresis on Refractory pain in Juvenile Rheumatoid arthritis

Study Overview

• Status: Recruiting
• Conditions: Juvenile Rheumatoid Arthritis
• Intervention / Treatment: Device: naproxen phonophoresis

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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marian Fayez, Ph.D; Phone Number: +201222748287; Email: mfayez@ecu.edu.eg
• Study Contact Backup: Name: Alaa Anwar, Ph.D; Phone Number: +201002538439; Email: Aalaa.anwar222@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Contact: Ahmed El Nahas, Ph.D; Phone Number: +201224134043; Email: aelnahhas@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee pain	change in refractory knee pain will be assessed by visual analogue scale	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee joint range of motion	change in the range of motion of knee joint will be measured by universal goniometer	2 weeks

Collaborators and Investigators

• Sponsor: Mohamed Abdelmoneim El Meligy
• Investigators: Principal Investigator: Mohamed Abo-El-Ros, Ph.d, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: August 13, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Refractory Pain Juvenile Rheumatoid Arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile; Pain, Intractable; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: P.T.REC/012/003788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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