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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130178
• Other study ID #: 4/10/2019
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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