Juvenile Rheumatoid ArthritisNCT05504382
Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial
A study testing naproxen phonophoresis in people with Juvenile Rheumatoid Arthritis, run by Mohamed Abdelmoneim El Meligy at 1 site in Egypt.
Trial summary
the purpose of the study is to investigate the effect of Electrical Acupuncture Versus naproxen phonophoresis on Refractory pain in Juvenile Rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 14 to 16 years
- Conditions the study is for
- Juvenile Rheumatoid Arthritis
- What is being tested?
- naproxen phonophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Ahmed El Nahas, Ph.D, +201224134043, aelnahhas@horus.edu.eg
About this study
Official title: 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
Read the 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
- Conditions
- Juvenile Rheumatoid Arthritis
- Being tested
- naproxen phonophoresis
- Keywords
- Refractory Pain Juvenile Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naproxen phonophoresisDevice
Also called electroacupuncture
transmission of naproxen molecule by therapeutic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | Experimental | receive especially electrical acupuncture on the knee joint Receives: Device: naproxen phonophoresis |
| study group 2 | Experimental | receive naproxen phonophoresis on the knee joint Receives: Device: naproxen phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee pain
change in refractory knee pain will be assessed by visual analogue scale
Measured: 2 weeks
Secondary outcomes (1)
knee joint range of motion
change in the range of motion of knee joint will be measured by universal goniometer
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Abdelmoneim El Meligy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Abdelmoneim El Meligy, Egyptian Chinese University
- Investigators
- Mohamed Abo-El-Ros, Ph.d, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504382
- Sponsor's protocol ID
- P.T.REC/012/003788
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture Versus Phonophoresis on Refractory Pain in Juvenile Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05504382
- Acronym / sponsor ID
- P.T.REC/012/003788
- Conditions
- Juvenile Rheumatoid Arthritis
- Keywords
- Refractory Pain Juvenile Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mohamed Abdelmoneim El MeligyUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| study group 1 | Experimental | Device: naproxen phonophoresisreceive especially electrical acupuncture on the knee joint |
| study group 2 | Experimental | Device: naproxen phonophoresisreceive naproxen phonophoresis on the knee joint |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Age ranges from 14 to 16 years.
Key exclusion criteria (5 listed)
- • Neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naproxen phonophoresisAlso: electroacupuncturetransmission of naproxen molecule by therapeutic ultrasound | Device | study group 1, study group 2 |
Primary outcome
knee pain
Time frame: 2 weeks
change in refractory knee pain will be assessed by visual analogue scale
1 secondary outcome
knee joint range of motion
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Juvenile Rheumatoid Arthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abo-El-Ros, Ph.d principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing naproxen phonophoresis in people with Juvenile Rheumatoid Arthritis, run by Mohamed Abdelmoneim El Meligy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Anwar, Ph.D (+201002538439, Aalaa.anwar222@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee pain (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.