- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04361513
Genicular Nerve Block in Rheuamtoid Arthritis
June 23, 2021 updated by: Ahmed Mahrous, Sohag University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Minya, Egypt, 82749
- Minia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- RA patients
- Age > 18
- unilateral persistent knee arthritis
Exclusion Criteria:
- Participants with severe knee osteoarthritis
- peripheral neuropathy
- psoriatic arthritis
- skin infection
- or those who have allergy for Bupivacaine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nerve block group
3 point genicular nerve block under ultrasound guidance.
half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.
|
3 point genicular nerve block
intra-articular injection of triamcinilone
|
Other: intra-articular steroid injection
1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.
|
3 point genicular nerve block
intra-articular injection of triamcinilone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 0 time after 2 weeks and after 12 weeks
|
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
|
at 0 time after 2 weeks and after 12 weeks
|
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
|
at 0 time after 2 weeks and after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2020
Primary Completion (Actual)
July 28, 2020
Study Completion (Actual)
July 28, 2020
Study Registration Dates
First Submitted
April 22, 2020
First Submitted That Met QC Criteria
April 22, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 25, 2021
Last Update Submitted That Met QC Criteria
June 23, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anesthetics, Local
- Triamcinolone
- Bupivacaine
Other Study ID Numbers
- 28/4/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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