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Completed

NCT Number: NCT04361513

Genicular Nerve Block in Rheuamtoid Arthritis

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.

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Key information

Conditions

Pain Inflammation Joint Function Disorder Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Minia university

Minya, 82749, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)

Drug

3 point genicular nerve block

triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

Drug

intra-articular injection of triamcinilone

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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