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

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT04130178

Collaborator

(none)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Nerve block Drug: Saline injection	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2019

Actual Primary Completion Date :

Jan 25, 2020

Actual Study Completion Date :

Jan 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacine injected Half ml of Bupivicaine hydrochloride .5% (Marcaine, Pfizer) was injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP on each side of the selected joint.	Drug: Nerve block block of the digital nerves in rheumatoid arthritis patient
Placebo Comparator: Control group Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint.	Drug: Saline injection subcutaneous saline injection

Arm

Intervention/Treatment

Active Comparator: Bupivacine injected

Half ml of Bupivicaine hydrochloride .5% (Marcaine, Pfizer) was injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP on each side of the selected joint.

Drug: Nerve block

block of the digital nerves in rheumatoid arthritis patient

Placebo Comparator: Control group

Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint.

Drug: Saline injection

subcutaneous saline injection

Outcome Measures

Primary Outcome Measures

Change in pain [0 time after 2 weeks and after 2 months]
by visual analogue sclae
Change in the degree of inflammation [at 0 time after 2 weeks and after 2 months]
Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag university	Sohag		Egypt	82749

Sponsors and Collaborators

Sohag University

Investigators

Principal Investigator: Ahmed Elsaman, PhD, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mahrous, Associate professor, Sohag University

ClinicalTrials.gov Identifier:

NCT04130178

Other Study ID Numbers:

4/10/2019

First Posted:

Oct 17, 2019

Last Update Posted:

Dec 28, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Dec 28, 2020