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Completed

NCT Number: NCT04130178

Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.

PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university

Sohag, 82749, Egypt

About this study

PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rheumatoid arthritis patient according to ACR/EULAR criteria
  • age >18
  • bilateral hand affection

Exclusion criteria

  • peripheral neuropathy
  • other chronic arthritis
  • patient who did mastectomy or any other hand operation

Treatment and study plan

Nerve block

Drug

block of the digital nerves in rheumatoid arthritis patient

Saline injection

Drug

subcutaneous saline injection

Primary outcomes

  1. Change in pain

    Time frame: 0 time after 2 weeks and after 2 months

    by visual analogue sclae

  2. Change in the degree of inflammation

    Time frame: at 0 time after 2 weeks and after 2 months

    Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2019
Registry last updated
Dec 28, 2020

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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