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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 belowSelect...
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
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 moreSecondary 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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
576 Previous Clinical Trials
3,139,878 Total Patients Enrolled
Mark Campbell, MDPrincipal InvestigatorElisabeth Bruyere Hospital and The Ottawa Hospital