What side effects are associated with this type of intervention?

Peripheral nerve blocks, such as the brachial plexus block, can have side effects including infection, bleeding, nerve damage, and allergic reactions to the anesthetic. Physiotherapy, while crucial for improving function and strength, can sometimes initially increase pain as the body adjusts to the activity. Combining these treatments aims to enhance pain relief and functional improvement, but patients should be monitored for these potential side effects.

What prior FDA approvals exist?

There are no specific FDA approvals for the combination of Brachial Plexus Block (Peripheral Nerve Blockade) and Physiotherapy for the treatment of Complex Regional Pain Syndrome (CRPS). However, nerve blocks, including sympathetic nerve blocks like stellate ganglion and lumbar sympathetic blocks, have been investigated for CRPS treatment. These interventions aim to alleviate pain by interrupting nerve signaling. Physiotherapy is commonly recommended to improve function and mobility in CRPS patients. While these treatments are used in practice, their efficacy varies, and they are often part of a broader, multidisciplinary approach to managing CRPS.

What other types of research exist?

Promising novel alternatives for treating Complex Regional Pain Syndrome (CRPS) in 2024 include: <ol> <li>Ketamine Infusions: Emerging evidence suggests that low-dose ketamine infusions can provide significant pain relief for CRPS patients.</li> <li></li> </ol> Spinal Cord Stimulation (SCS): This technique involves implanting a device that sends electrical impulses to the spinal cord, which can help reduce pain. 3. Intravenous Immunoglobulin (IVIG): Some studies indicate that IVIG may help reduce pain and improve function in CRPS patients. 4. Hyperbaric Oxygen Therapy (HBOT): This treatment involves breathing pure oxygen in a pressurized room, which may help reduce pain and inflammation. 5. Bisphosphonates: These medications, typically used for bone diseases, have shown promise in reducing CRPS pain in some studies.

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Procedure

Nerve Block + Physiotherapy for Complex Regional Pain Syndrome

N/A

Waitlist Available

Research Sponsored by Tracy Cupido

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment for adults with Complex Regional Pain Syndrome (CRPS), a severe chronic pain condition. The treatment involves an injection near the shoulder to block pain signals, followed by a program of physical exercises. Researchers hope this combination will be more effective than exercises alone in reducing pain and improving function.

Who is the study for?

This trial is for adults over 18 with Complex Regional Pain Syndrome (CRPS) in the upper extremity who can consent to treatment. It's not suitable for those allergic to local anesthetics or chlorhexidine, have an infection at the injection site, had regional anesthesia for CRPS within 6 months, cannot tolerate anesthesia or physiotherapy, have another pain condition affecting the same limb, or cannot consent.

What is being tested?

The study is testing if a single-shot axillary brachial plexus block combined with physiotherapy is more effective than just physiotherapy alone in treating CRPS. The goal is to see if this new approach improves pain and function better than current treatments.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or infection, allergic reactions to the anesthetic used during nerve block procedures, and typical risks associated with physiotherapy like muscle soreness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility Assessment

Secondary study objectives

Cost

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Axillary Brachial Plexus Block plus PhysiotherapyExperimental Treatment1 Intervention

Participants who are randomized to the experimental group (EXP arm) will receive a single-shot axillary-approach brachial plexus block with 1.5mg/kg (up to 50mg total) bupivacaine 0.25% at the Kingston Health Sciences Centre Chronic Pain Clinic (KHSC-CPC). Prior to treatment, a blinded third party will perform a baseline physical exam. Under the brachial plexus block, the physiotherapist will provide standard of care, including manual therapy. The patient will then complete a 6-week physiotherapy program, including GMI. Following the 6 week program, a blind observer will repeat the physical exam.

Group II: Physiotherapy aloneActive Control1 Intervention

Participants who are randomized to not receive a block (CON arm) will also have a baseline physical exam performed by a blinded third party. Following baseline data collection, the physiotherapist will provide standard of care, including manual therapy. They will then complete a 6-week home exercise program, including GMI. Following the 6 week program, a blinded observer will repeat the physical exam.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Brachial Plexus Block (Peripheral Nerve Blockade) works by temporarily interrupting the transmission of pain signals from the affected nerves, which can provide significant pain relief and reduce autonomic and inflammatory changes associated with CRPS. Physiotherapy, on the other hand, aims to improve function and reduce pain through targeted exercises and manual therapy, addressing muscle stiffness, joint mobility, and overall limb function. Combining these treatments can be particularly beneficial for CRPS patients as the nerve block provides immediate pain relief, allowing patients to participate more effectively in physiotherapy, which can lead to long-term improvements in pain management and functional recovery.