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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Nerve block

Saline injection

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sohag university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacine injected

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in pain

by visual analogue sclae

Change in the degree of inflammation

Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

Secondary Outcome Measures

Full Information

NCT ID

NCT04130178

First Posted

October 11, 2019

Last Updated

December 23, 2020

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04130178

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

October 15, 2019 (Actual)

Primary Completion Date

January 25, 2020 (Actual)

Study Completion Date

January 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

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.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacine injected

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nerve block

Intervention Description

block of the digital nerves in rheumatoid arthritis patient

Intervention Type

Drug

Intervention Name(s)

Saline injection

Intervention Description

subcutaneous saline injection

Primary Outcome Measure Information:

Title

Change in pain

Description

by visual analogue sclae

Time Frame

0 time after 2 weeks and after 2 months

Title

Change in the degree of inflammation

Description

Musculoskeletal ultrasound evaluation by EULAR-OMERACT score

Time Frame

at 0 time after 2 weeks and after 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Elsaman, PhD

Organizational Affiliation

Sohag University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sohag university

City

Sohag

ZIP/Postal Code

82749

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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