Peripheral Nerve Injections for Complex Regional Pain Syndrome

Not currently recruiting at 1 trial location

Overseen By Mark Campbell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Uncontrolled hypertension, Sepsis, Active cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether nerve injections can reduce pain in individuals with complex regional pain syndrome (CRPS) in the arms. CRPS is characterized by intense pain and changes in skin color or temperature, often following surgery or injury. Participants will receive injections of either medication (bupivacaine and a steroid) or a placebo (saltwater solution) near specific nerves. Those who meet the Budapest Criteria for upper arm CRPS and experience significant pain may be suitable for this study. The goal is to evaluate the effectiveness of these peripheral nerve injections and prepare for a larger study if successful. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in CRPS pain management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that peripheral nerve injections are safe for treating complex regional pain syndrome?

Research has shown that peripheral nerve blocks can be safe for people with complex regional pain syndrome (CRPS). In a small study, participants tolerated these injections, which target nerves in the shoulder and hand, well. The study found that pain decreased significantly: 56% less in the shoulder and 37% less in the hand just two weeks after treatment. This suggests the procedure may be both effective and safe for many people. However, larger studies are needed to confirm these results and fully understand the safety and effectiveness of these nerve blocks for CRPS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about peripheral nerve injections for Complex Regional Pain Syndrome (CRPS) because they offer a targeted approach that directly addresses nerve pain. Unlike standard treatments that often involve oral medications like gabapentin or opioids, these injections deliver anesthetics like Bupivacaine and steroids like Kenalog directly to the affected nerves, potentially providing faster and more localized relief. This method may reduce systemic side effects and dependency associated with oral drugs, offering a more precise and effective treatment option for CRPS patients.

What evidence suggests that peripheral nerve injections might be an effective treatment for complex regional pain syndrome?

Research has shown that peripheral nerve blocks can effectively reduce pain in various muscle and nerve conditions. In this trial, participants in the treatment arm will receive peripheral nerve injections targeting the suprascapular, median, and ulnar nerves. A small initial study found that patients with complex regional pain syndrome (CRPS) experienced a significant reduction in pain after receiving nerve blocks. Specifically, pain decreased by 56% in the shoulder and 37% in the hand two weeks after the injection. These findings suggest that targeting certain nerve fibers may help manage CRPS pain. While these early results are promising, larger studies are needed to confirm them. ^{1 4 5 6 7}

Who Is on the Research Team?

Mark Campbell, MD

Principal Investigator

Elisabeth Bruyere Hospital and The Ottawa Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Satisfy the Budapest Criteria for upper extremity CRPS

Able to provide signed and dated informed consent form

I experience significant pain in my upper extremity, scoring at least 40 on the VAS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive peripheral nerve injections with either bupivacaine and triamcinolone acetonide or placebo (saline) for CRPS

12 weeks

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral Nerve Injections

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 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: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04744675

NCT04744675 | Peripheral Nerve Injections for CRPS Peripheral nerve blocks have proven to be successful in reducing pain for several musculoskeletal and neurologic conditions.

2. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40264

Peripheral Nerve Blocks and Procedures for Chronic Pain Use this page to view details for the Local Coverage Determination for Peripheral Nerve Blocks and Procedures for Chronic Pain.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028384318300173

Effectiveness of complex regional pain syndrome treatment Improvement has been reported with topical dimethyl sulfoxide, systemic steroids, spinal cord stimulation and graded motor imagery/mirror therapy programmes.

4. clinicaltrial.be clinicaltrial.be/en/details/20263?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Peripheral Nerve Injections for CRPS In a small exploratory study, investigators found peripheral nerve blocks in the upper extremity (suprascapular and median nerves) were well- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8586061/

Peripheral Nerve Stimulation for Chronic Pain: A Systematic ... The evidence suggests that approximately two-thirds of patients with peripheral neuropathic pain will have at least 50% sustained pain relief.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10953611/

Sustained Relief of Complex Regional Pain Syndrome (CRPS ... These three cases suggest that 60-day PNS is a safe and efficacious treatment for CRPS. Keywords: chronic pain, 60-day pns, neurostimulation, ...

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40299&ver=2

Peripheral Nerve Blocks and Procedures for Chronic Pain Use this page to view details for the Local Coverage Determination for Peripheral Nerve Blocks and Procedures for Chronic Pain.