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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04130178
Other study ID # 4/10/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date January 25, 2020

Study information

Verified date December 2020
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 25, 2020
Est. primary completion date January 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nerve block
block of the digital nerves in rheumatoid arthritis patient
Saline injection
subcutaneous saline injection

Locations

Country Name City State
Egypt Sohag university Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain by visual analogue sclae 0 time after 2 weeks and after 2 months
Primary Change in the degree of inflammation Musculoskeletal ultrasound evaluation by EULAR-OMERACT score at 0 time after 2 weeks and after 2 months
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