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

Study Overview
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Nerve block
* Drug: Saline injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacine injected<br>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<br>* block of the digital nerves in rheumatoid arthritis patient<br>|
| Placebo Comparator: Control group<br>Saline was injected subcutaneously in the 2nd and 3rd PIP on each side of the selected joint. | Drug: Saline injection<br>* subcutaneous saline injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | by visual analogue sclae | 0 time after 2 weeks and after 2 months | 
| Change in the degree of inflammation | Musculoskeletal ultrasound evaluation by EULAR-OMERACT score | at 0 time after 2 weeks and after 2 months |