Genicular Nerve Block in Rheuamtoid Arthritis

Pain Clinical Trial

Official title:

Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361513
• Other study ID #: 28/4/2020
• Status: Completed
• Phase: Phase 4
• Start date: April 15, 2020
• Est. completion date: July 28, 2020

Study information

• Verified date: June 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Joint Function Disorder
• Pain

Intervention

Drug:
• Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)
3 point genicular nerve block
• triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)
intra-articular injection of triamcinilone

Locations

Country	Name	City	State
Egypt	Minia university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain changes by VAS	0 means no pain and 10 means the most severe pain	at 0 time after 2 weeks and after 12 weeks
Primary	SOLAR score for inflammation changes by ultrasound	0 means normal and 27 means the worst possible inflammation	at 0 time after 2 weeks and after 12 weeks
Primary	Lysholm score for change in knee function	100 means the best performance and 0 means complete loss of function	at 0 time after 2 weeks and after 12 weeks