PainPhase 4NCT04361513
Genicular Nerve Block in Rheuamtoid Arthritis
A Phase 4 study testing Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) and triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) in people with Pain and Joint Function Disorder, run by Sohag University at 1 site in Egypt.
Trial summary
N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Joint Function Disorder, Inflammation
- What is being tested?
- Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) and triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 28 Jul 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA patients
- Age > 18
- unilateral persistent knee arthritis
Who cannot join
- Participants with severe knee osteoarthritis
- peripheral neuropathy
- psoriatic arthritis
- skin infection
- or those who have allergy for Bupivacaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial
N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.
- Conditions
- Pain, Joint Function Disorder, Inflammation
- Being tested
- Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer), triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)Drug
3 point genicular nerve block
triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)Drug
intra-articular injection of triamcinilone
| Study group | Role | What they receive |
|---|---|---|
| Nerve block group | Active comparator | 3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point. Receives: Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer); Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) |
| intra-articular steroid injection | Other | 1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular. Receives: Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer); Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain changes by VAS
0 means no pain and 10 means the most severe pain
Measured: at 0 time after 2 weeks and after 12 weeks
SOLAR score for inflammation changes by ultrasound
0 means normal and 27 means the worst possible inflammation
Measured: at 0 time after 2 weeks and after 12 weeks
Lysholm score for change in knee function
100 means the best performance and 0 means complete loss of function
Measured: at 0 time after 2 weeks and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Apr 2020
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Model description
- Group received nerve block and another group received steroid
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 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
- NCT04361513
- Sponsor's protocol ID
- 28/4/2020
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2020
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04361513
- Acronym / sponsor ID
- 28/4/2020
- Conditions
- Pain, Joint Function Disorder, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 24 Apr 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=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was 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
- Model description
- Group received nerve block and another group received steroid
| Arm | Type | Receives |
|---|---|---|
| Nerve block group | Active comparator | Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer), Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point. |
| intra-articular steroid injection | Other | Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer), Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- RA patients
- Age > 18
- unilateral persistent knee arthritis
Key exclusion criteria (5 listed)
- Participants with severe knee osteoarthritis
- peripheral neuropathy
- psoriatic arthritis
- skin infection
- or those who have allergy for Bupivacaine
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 |
|---|---|---|
| Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)3 point genicular nerve block | Drug | Nerve block group, intra-articular steroid injection |
| triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)intra-articular injection of triamcinilone | Drug | Nerve block group, intra-articular steroid injection |
Primary outcome
Pain changes by VAS
Time frame: at 0 time after 2 weeks and after 12 weeks
0 means no pain and 10 means the most severe pain
SOLAR score for inflammation changes by ultrasound
Time frame: at 0 time after 2 weeks and after 12 weeks
0 means normal and 27 means the worst possible inflammation
Lysholm score for change in knee function
Time frame: at 0 time after 2 weeks and after 12 weeks
100 means the best performance and 0 means complete loss of function
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 25 Jun 2021.
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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 Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) and triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) in people with Pain and Joint Function Disorder, 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 3 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: finished, as of the sponsor's last update on 25 Jun 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?
Pain changes by VAS (time frame: at 0 time after 2 weeks and after 12 weeks). The study lists 3 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 25 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.