Juvenile Idiopathic ArthritisPhase 4NCT04687930
Genicular Nerve Block in Juvenile Idiopathic Arthritis
A Phase 4 study testing genicular nerve block and intra-articular steroid injection in people with Juvenile Idiopathic Arthritis and Persistent Knee Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
N=104 juvenile idiopathic arthritis patients diagnosed after ILAR criteria with unilateral persistent knee arthritis. They will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Persistent Knee Arthritis, no Intra-articular Injection in the Last 3 Months
- What is being tested?
- genicular nerve block and intra-articular steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 15 Feb 2021
- Phase
- Phase 4
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- juvenile idiopathic arthritis with persistent knee arthritis
- age below 16
Who cannot join
- severe knee osteoarthritis
- peripheral neuropathy,
- psoriatic arthritis,
- those under anticoagulant therapy, skin infection,
- prior knee injection in the last 3 months3
- those who have an allergy to Bupivacaine
Trial locations and contacts
1 site in 1 country.
About this study
N=104 juvenile idiopathic arthritis patients diagnosed after ILAR criteria with unilateral persistent knee arthritis. They will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. Both groups will be examined by SOLAR ultrasound scoring system, Visual analogue scale and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score will be used to assess tenderness and swelling at the same intervals.
- Conditions
- Juvenile Idiopathic Arthritis, Persistent Knee Arthritis, no Intra-articular Injection in the Last 3 Months, no Other Cause for Chronic Kneearthritis
- Being tested
- genicular nerve block, intra-articular steroid injection
- Keywords
- Juvenile rheumatoid arthritis, knee joint, Nerve block
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve blockDrug
nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.
intra-articular steroid injectionDrug
Triamcinilone injection into the knee joint under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Active genicular nerve block group | Active comparator | group 1 will receive genicular nerve block. The injection and US examination will be done by two experienced sonographers. They were blinded to clinical data. Patients will also be blinded for the injected substance. Each point will be injected with 2 ml of Lidocaine hydrochloride 2 % (Xylocaine, Astrazeneca). The injection will be done using the 3 point technique (superior medial, superior lateral, and inferior medial genicular nerves). Receives: Drug: genicular nerve block |
| intra-articular steroid injection group | Other | while group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa. Receives: Drug: intra-articular steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SOLAR score over time
score to assess ultrasound parameters of the knee including power doppler and grey scale measures
Measured: Baseline, 2 weeks and 12 weeks
Change in visual analogue scale over time
a graded score for pain evaluation filled by the patient graded from 0 to 10
Measured: Baseline, 2 weeks and 12 weeks
Change in Lysholm score over time
a score to assess knee function. This questionnaire has 8 domains. A score between 95 and 100 means excellent functional performance, good 84-94, fair 65-83 and poor <64
Measured: Baseline, 2 weeks and 12 weeks
Change in semiquantitative score for swelling and tenderness over time
A score graded from 0 to 3; score 0 means no swelling nor tenderness and 3 means maximum swelling and tenderness
Measured: Baseline, 2 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Dec 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 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
- NCT04687930
- Sponsor's protocol ID
- 8122020
- Status last verified
- Jul 2021
- First submitted
- 19 Dec 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Radwan A, Ohrndorf S, Aly H, Hamed M, Khalifa A, Elsaman AM. Genicular nerve block in juvenile idiopathic arthritis: a randomized clinical trial. Clin Rheumatol. 2023 Mar;42(3):879-888. doi: 10.1007/s10067-022-06389-4. Epub 2022 Oct 5.
PubMed 36197647
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Nerve Block in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT04687930
- Acronym / sponsor ID
- 8122020
- Conditions
- Juvenile Idiopathic Arthritis, Persistent Knee Arthritis, no Intra-articular Injection in the Last 3 Months, no Other Cause for Chronic Kneearthritis
- Keywords
- Juvenile rheumatoid arthritis, knee joint, Nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 29 Dec 2020 (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.
N=104 juvenile idiopathic arthritis patients diagnosed after ILAR criteria with unilateral persistent knee arthritis. They will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. Both groups will be examined by SOLAR ultrasound scoring system, Visual analogue scale and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score will be used to assess tenderness and swelling at the same intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active genicular nerve block group | Active comparator | Drug: genicular nerve blockgroup 1 will receive genicular nerve block. The injection and US examination will be done by two experienced sonographers. They were blinded to clinical data. Patients will also be blinded for the injected substance. Each point will be injected with 2 ml of Lidocaine hydrochloride 2 % (Xylocaine, Astrazeneca). The injection will be done using the 3 point technique (superior medial, superior lateral, and inferior medial genicular nerves). |
| intra-articular steroid injection group | Other | Drug: intra-articular steroid injectionwhile group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- juvenile idiopathic arthritis with persistent knee arthritis
- age below 16
Key exclusion criteria (6 listed)
- severe knee osteoarthritis
- peripheral neuropathy,
- psoriatic arthritis,
- those under anticoagulant therapy, skin infection,
- prior knee injection in the last 3 months3
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 |
|---|---|---|
| genicular nerve blocknerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound. | Drug | Active genicular nerve block group |
| intra-articular steroid injectionTriamcinilone injection into the knee joint under ultrasound guidance. | Drug | intra-articular steroid injection group |
Primary outcome
Change in SOLAR score over time
Time frame: Baseline, 2 weeks and 12 weeks
score to assess ultrasound parameters of the knee including power doppler and grey scale measures
Change in visual analogue scale over time
Time frame: Baseline, 2 weeks and 12 weeks
a graded score for pain evaluation filled by the patient graded from 0 to 10
Change in Lysholm score over time
Time frame: Baseline, 2 weeks and 12 weeks
a score to assess knee function. This questionnaire has 8 domains. A score between 95 and 100 means excellent functional performance, good 84-94, fair 65-83 and poor <64
Change in semiquantitative score for swelling and tenderness over time
Time frame: Baseline, 2 weeks and 12 weeks
A score graded from 0 to 3; score 0 means no swelling nor tenderness and 3 means maximum swelling and tenderness
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 23 Jul 2021.
- Derived from this study: PubMed 36197647Radwan A, Ohrndorf S, Aly H, Hamed M, Khalifa A, Elsaman AM. Genicular nerve block in juvenile idiopathic arthritis: a randomized clinical trial. Clin Rheumatol. 2023 Mar;42(3):879-888. doi: 10.1007/s10067-022-06389-4. Epub 2022 Oct 5.
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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 4 study testing genicular nerve block and intra-articular steroid injection in people with Juvenile Idiopathic Arthritis and Persistent Knee 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 2 inclusion and 6 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 23 Jul 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 SOLAR score over time (time frame: Baseline, 2 weeks and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687930, which also lists 1 linked publication.
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 23 Jul 2021.