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Peripheral Nerve Injections for Complex Regional Pain Syndrome

Phase 2

Waitlist Available

Led By Mark Campbell, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged ≥18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial will test the feasibility of performing a placebo-controlled RCT to study the efficacy and safety of peripheral nerve blocks in reducing pain for patients with CRPS.

Who is the study for?

This trial is for adults over 18 with upper extremity Complex Regional Pain Syndrome (CRPS) who meet the Budapest Criteria and have significant pain, indicated by a score of at least 40 mm on the visual analog scale. Participants must be able to consent to treatment.

What is being tested?

The study tests nerve blocks as a CRPS treatment in the arms. Patients are randomly assigned to receive either bupivacaine and triamcinolone injections or placebo saline injections, alongside standard CRPS care.

What are the potential side effects?

Potential side effects may include discomfort at injection sites, allergic reactions to medications used, temporary numbness or weakness in injected areas, and less commonly systemic steroid-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blinding - Interventionist

Blinding - Participant

Blinding - Physiotherapist

+5 more

Secondary study objectives

Disease Severity - Complex Regional Pain Syndrome Severity Score

Emotional and Psychological Function - EQ-5D-5L

Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2

+7 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment2 Interventions

The intervention group will receive: 1. Suprascapular nerve block - 3 mL of 0.5% Bupivacaine and 1 mL of 40 mg/mL Kenalog 2. Median nerve block - 3.5 mL of 0.5% Bupivacaine and 0.5 mL of 40 mg/mL Kenalog 3. Ulnar nerve block - 3.5 mL of 0.5% Bupivacaine and 0.5 mL of 40 mg/mL Kenalog

Group II: PlaceboPlacebo Group1 Intervention

Placebo The placebo group will receive: 1. Suprascapular nerve injection - 4 mL of normal saline 2. Median nerve injection - 4 mL of normal saline 3. Ulnar nerve injection - 4 mL of normal saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

2013

Completed Phase 4

~1530

Triamcinolone

FDA approved

0 / 1Eligibility criteria met