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Genicular Nerve Block in Rheuamtoid Arthritis

Primary Purpose

Pain, Joint Function Disorder, Inflammation

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)

triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Minia university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Nerve block group

intra-articular steroid injection

Arm Description

3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.

1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.

Outcomes

Primary Outcome Measures

Pain changes by VAS

0 means no pain and 10 means the most severe pain

SOLAR score for inflammation changes by ultrasound

0 means normal and 27 means the worst possible inflammation

Lysholm score for change in knee function

100 means the best performance and 0 means complete loss of function

Secondary Outcome Measures

Full Information

NCT ID

NCT04361513

First Posted

April 22, 2020

Last Updated

June 23, 2021

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04361513

Brief Title

Genicular Nerve Block in Rheuamtoid Arthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 15, 2020 (Actual)

Primary Completion Date

July 28, 2020 (Actual)

Study Completion Date

July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Joint Function Disorder, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Group received nerve block and another group received steroid

Masking

Participant

Masking Description

The participants does not know the nature of the injected material. Syringe was colored to cover it

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nerve block group

Arm Type

Active Comparator

Arm Description

3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.

Arm Title

intra-articular steroid injection

Arm Type

Other

Arm Description

1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)

Intervention Description

3 point genicular nerve block

Intervention Type

Drug

Intervention Name(s)

triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

Intervention Description

intra-articular injection of triamcinilone

Primary Outcome Measure Information:

Title

Pain changes by VAS

Description

0 means no pain and 10 means the most severe pain

Time Frame

at 0 time after 2 weeks and after 12 weeks

Title

SOLAR score for inflammation changes by ultrasound

Description

0 means normal and 27 means the worst possible inflammation

Time Frame

at 0 time after 2 weeks and after 12 weeks

Title

Lysholm score for change in knee function

Description

100 means the best performance and 0 means complete loss of function

Time Frame

at 0 time after 2 weeks and after 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Minia university

City

Minya

ZIP/Postal Code

82749

Country

Egypt

12. IPD Sharing Statement

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Genicular Nerve Block in Rheuamtoid Arthritis

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