NCT05504382

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 13, 2022

Last Update Submit

August 15, 2022

Conditions

Keywords

Refractory Pain Juvenile Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • knee pain

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

    2 weeks

Secondary Outcomes (1)

  • knee joint range of motion

    2 weeks

Study Arms (2)

study group 1

EXPERIMENTAL

receive especially electrical acupuncture on the knee joint

Device: naproxen phonophoresis

study group 2

EXPERIMENTAL

receive naproxen phonophoresis on the knee joint

Device: naproxen phonophoresis

Interventions

transmission of naproxen molecule by therapeutic ultrasound

Also known as: electroacupuncture
study group 1study group 2

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Mohamed Abo-El-Ros, Ph.d

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marian Fayez, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR. Mohamed Abdelmoeim Ahmed Abo-El-Ros

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 17, 2022

Study Start

August 1, 2022

Primary Completion

November 1, 2022

Study Completion

May 1, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations