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

NCT ID: NCT04130178

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-01-25

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nerve block

Intervention Type DRUG

block of the digital nerves in rheumatoid arthritis patient

Control group

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

Group Type PLACEBO_COMPARATOR

Saline injection

Intervention Type DRUG

subcutaneous saline injection

Interventions

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Nerve block

block of the digital nerves in rheumatoid arthritis patient

Intervention Type DRUG

Saline injection

subcutaneous saline injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahrous

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Elsaman, PhD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

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Sohag university

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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4/10/2019

Identifier Type: -

Identifier Source: org_study_id