Genicular Nerve Block in Rheuamtoid Arthritis

NCT04361513 | Completed Phase 4

• 1 other identifier: 28/4/2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Joint Function Disorder; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

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.

Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer); Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

Interventions

Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) DRUG

3 point genicular nerve block

Nerve block group; intra-articular steroid injection

triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) DRUG

intra-articular injection of triamcinilone

Nerve block group; intra-articular steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RA patients
• Age \> 18
• unilateral persistent knee arthritis

You may not qualify if:

• Participants with severe knee osteoarthritis
• peripheral neuropathy
• psoriatic arthritis
• skin infection
• or those who have allergy for Bupivacaine

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Minia university

Minya, 82749, Egypt

Location

MeSH Terms

Conditions

Pain; Inflammation

Interventions

Bupivacaine; Triamcinolone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants does not know the nature of the injected material. Syringe was colored to cover it
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Group received nerve block and another group received steroid

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: April 15, 2020
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

EG (1)