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

Intervention / Treatment

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

  • Egypt
      • 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.
Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)
3 point genicular nerve block
Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)
intra-articular injection of triamcinilone
Other: intra-articular steroid injection
1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.
Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)
3 point genicular nerve block
Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)
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

Sohag University

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

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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