NCT05589259

Feasibility Study of Combined Peripheral Nerve Block and Physiotherapy for CRPS

Not yet recruiting NA Last updated 15 March 2024

What this trial tests

NA trial testing Axillary Brachial Plexus Block plus Physiotherapy in Complex Regional Pain Syndromes in 60 participants. Not yet recruiting.

Timeline

1 February 2025

Primary endpoint
1 September 2025

1 September 2026

Quick facts

Lead sponsor	Tracy Cupido
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 February 2025
Primary completion	1 September 2025
Estimated completion	1 September 2026
Sites	1 location across Canada

Drugs / interventions tested

• Axillary Brachial Plexus Block plus Physiotherapy
• Physiotherapy alone

Conditions studied

• Complex Regional Pain Syndromes — all drugs for Complex Regional Pain Syndromes →

Sponsor

Tracy Cupido

Who can join

Adults 18 to 110, any sex, with Complex Regional Pain Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic pain on patient quality of life and on healthcare costs. Due to the complexity of chronic pain and differences between the multitudes of pain conditions, developing effective treatments is challenging. This is especially true for Complex Regional Pain Syndrome (CRPS).

CRPS is characterized by severe pain out of proportion to tissue trauma, with local autonomic and inflammatory changes. The severity of pain from CRPS may result in an inability to work, depression, sleep disorders, or suicidal ideation.

Although its prevalence is low in Canada, CRPS is considered one the most debilitating and least understood pain conditions. As most current treatment options have low evidence of effectiveness, there is no definitive treatment available and most often, patients are struggling to maintain an acceptable quality of life. Thus, there is a pressing need to identify new and improved treatments for adults with CRPS.

An early hypothesis of CRPS pathophysiology posited that sympathetic nervous system over-activity led to many of the signs and symptoms of CRPS. As such, sympathetic nerve blocks, including stellate ganglion and lumbar sympathetic blocks, have been repeatedly investigated as a potential treatment of CRPS. However, a recent meta-analysis suggests that these blocks provided no benefits for those suffering with CRPS. Newer evidence suggests that a peripheral microvascular dysfunction may underlie CRPS pathophysiology. However, no clinical trials have investigated the efficacy of a treatment targeting this peripheral pathway.

The goal of this project is to assess the efficacy of a single-shot axillary approach to the brachial plexus block plus physiotherapy as a novel treatment protocol for CRPS. Our primary hypothesis is that providing a brachial plexus block in conjunction with a physiotherapy program would be superior to physiotherapy alone in treating pain and function in CRPS. Since this is a novel treatment protocol for CRPS, the purpose of our proposed study is to determine the feasibility of conducting a fully powered clinical trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.