Juvenile Idiopathic ArthritisPhase 3NCT04775225
Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis
A Phase 3 study testing Lidocaine and Steroid in people with Juvenile Idiopathic Arthritis and Hip Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Hip Arthritis
- What is being tested?
- Lidocaine and Steroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2021to 6 Apr 2021
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with JIA with unilateral hip arthritis
Who cannot join
- hip involvement due to other causes including
- septic arthritis
- other connective tissue diseases
- Avascular necrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hip Denervation in Juvenile Idiopathic Arthritis
Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS score. These outcomes were measured at baseline, 2 weeks, and 16 weeks
Read the detailed description
The aim of the study is to test the effect of denervation of the active hip in JIA and compare it with a placebo without changing systemic treatment during the study. Outcome measures included pain, range of motion, SOLAR score, and Harris functional score.
- Conditions
- Juvenile Idiopathic Arthritis, Hip Arthritis
- Being tested
- Lidocaine, Placebo, Steroid
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called The active denervation group
denervation of the obturator and femoral genicular branches by Lidocaine 2 %
PlaceboDrug
Also called The control group
an equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group
SteroidDrug
Also called The active steroid group
Intra-articular injection of 80mg of triamcinolone
| Study group | Role | What they receive |
|---|---|---|
| Hip denervation group | Active comparator | This group will receive Lidocaine 2% block of the femoral and obturator genicular branches. Receives: Drug: Lidocaine |
| control group | Placebo comparator | this group will receive saline injection subcutaneously at the same places. Receives: Drug: Placebo |
| Steroid | Active comparator | This group with receiving an intra-articular injection of 80mg triamcinolone Receives: Drug: Steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale
a scale from 0-100 will be used 0 means no pain 100 means the maximum pain
Measured: Baseline, 2 weeks and 16 weeks
Change in range of motion
flexion, internal rotation, external rotation range will be calculated
Measured: Baseline, 2 weeks and 16 weeks
Change in Harris functional score
100 means best results and 0 means worst results
Measured: Baseline, 2 weeks and 16 weeks
semiquantitative tenderness score
0 means no tenderness and 3 means maximum tenderness
Measured: Baseline, 2 weeks and 16 weeks
Change in SOLAR score
GSUS. 0 means the least synovitis and the maximum, PDUS, o means no PD and 3 the maximum
Measured: Baseline, 2 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start6 Jan 2021
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775225
- Sponsor's protocol ID
- 3012020
- Status last verified
- Jan 2023
- First submitted
- 17 Feb 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Denervation in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT04775225
- Acronym / sponsor ID
- 3012020
- Conditions
- Juvenile Idiopathic Arthritis, Hip Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 1 Mar 2021 (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.
Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS score. These outcomes were measured at baseline, 2 weeks, and 16 weeks
Detailed description
The aim of the study is to test the effect of denervation of the active hip in JIA and compare it with a placebo without changing systemic treatment during the study. Outcome measures included pain, range of motion, SOLAR score, and Harris functional score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hip denervation group | Active comparator | Drug: LidocaineThis group will receive Lidocaine 2% block of the femoral and obturator genicular branches. |
| control group | Placebo comparator | Drug: Placebothis group will receive saline injection subcutaneously at the same places. |
| Steroid | Active comparator | Drug: SteroidThis group with receiving an intra-articular injection of 80mg triamcinolone |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with JIA with unilateral hip arthritis
Key exclusion criteria (4 listed)
- hip involvement due to other causes including
- septic arthritis
- other connective tissue diseases
- Avascular necrosis
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 |
|---|---|---|
| LidocaineAlso: The active denervation groupdenervation of the obturator and femoral genicular branches by Lidocaine 2 % | Drug | Hip denervation group |
| PlaceboAlso: The control groupan equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group | Drug | control group |
| SteroidAlso: The active steroid groupIntra-articular injection of 80mg of triamcinolone | Drug | Steroid |
Primary outcome
Change in visual analogue scale
Time frame: Baseline, 2 weeks and 16 weeks
a scale from 0-100 will be used 0 means no pain 100 means the maximum pain
Change in range of motion
Time frame: Baseline, 2 weeks and 16 weeks
flexion, internal rotation, external rotation range will be calculated
Change in Harris functional score
Time frame: Baseline, 2 weeks and 16 weeks
100 means best results and 0 means worst results
semiquantitative tenderness score
Time frame: Baseline, 2 weeks and 16 weeks
0 means no tenderness and 3 means maximum tenderness
Change in SOLAR score
Time frame: Baseline, 2 weeks and 16 weeks
GSUS. 0 means the least synovitis and the maximum, PDUS, o means no PD and 3 the maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and Steroid in people with Juvenile Idiopathic Arthritis and Hip Arthritis, run by Sohag University 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jan 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analogue scale (time frame: Baseline, 2 weeks and 16 weeks). The study lists 5 primary outcomes in all. 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 Jan 2023.