Peripheral Nerve Injections for CRPS

NCT ID: NCT04744675

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2025-06-30

Brief Summary

Background Complex regional pain syndrome (CRPS) is characterized by intense pain, loss of function, and associated with motor, trophic, sudomotor, and/or vasomotor changes of the affected extremity. Upper extremity CRPS is seen frequently in electrodiagnostic, neurology, and musculoskeletal clinics and occurs in up to one-third of patients who have undergone common surgical procedures (i.e. carpal tunnel surgery). To date, there is a limited understanding of the underlying pathophysiology of CRPS. As a consequence, few effective treatment options are available.

Peripheral nerve blocks have proven to be successful in reducing pain for several musculoskeletal and neurologic conditions. Similarly, this procedure could be used to block somatic and autonomic sensory fibers which are thought to contribute to CRPS. In a small exploratory study, investigators found peripheral nerve blocks in the upper extremity (suprascapular and median nerves) were well-tolerated in patients with CRPS and resulted in a 56% and 37% pain reduction in the shoulder and hand 2 weeks after injection, respectively. While this is highly encouraging, large randomized placebo-controlled trials (RCTs) are necessary to demonstrate effectiveness and safety of nerve blocks for this population before it is accepted into clinical practice. This proposal is a phase II feasibility study that will test the critical elements necessary for performing such a RCT.

Methods The investigators will recruit participants (≥18 years old) from The Ottawa Hospital, Bruyère Continuing Care (Elisabeth Bruyère Hospital, St-Vincent Hospital), and Providence Care Hospital (Kingston, ON), meeting the well-established clinical Budapest criteria for upper extremity CRPS and having a visual analog scale (VAS) pain score of at least 40 mm (to avoid flooring effect). Participants will be block-randomized by the Ottawa Methods Centre to receive injections of either A) intervention (suprascapular, median, and ulnar nerves) with bupivacaine and triamcinolone acetonide, or B) placebo (saline). All participants will receive standard care for CRPS.

Primary outcomes will focus on crucial methodologic aspects for the future RCT, including: (1) level of recruitment, (2) rate of acceptance from eligible patients to the randomization procedure, (3) blinding efficacy, (4) degree of patient retention, (5) rate of data completion, and (6) rate of adverse events for both the placebo and intervention groups.

Conditions

Complex Regional Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

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 Type: EXPERIMENTAL

Triamcinolone Acetonide 40mg/mL

Intervention Type: DRUG

Triamcinolone acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intramuscular, intra-articular, and intrabursal injection.

Bupivacaine

Intervention Type: DRUG

Bupivacaine is an anesthetic that is commonly used as a local numbing agent, including intramuscular, intra-articular and intrabursal injections.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline Injection

Intervention Type: DRUG

Saline is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium chloride and, in some formulations, potassium chloride and potassium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body.

Interventions

Triamcinolone Acetonide 40mg/mL

Triamcinolone acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intramuscular, intra-articular, and intrabursal injection.

Intervention Type: DRUG

Saline Injection

Saline is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium chloride and, in some formulations, potassium chloride and potassium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body.

Intervention Type: DRUG

Bupivacaine

Bupivacaine is an anesthetic that is commonly used as a local numbing agent, including intramuscular, intra-articular and intrabursal injections.

Intervention Type: DRUG

Other Intervention Names

Kenalog; Marcaine

Eligibility Criteria

Inclusion Criteria

1. Able to provide signed and dated informed consent form

2. Male or female, aged ≥18 years old

3. Satisfy the Budapest Criteria for upper extremity CRPS

4. A VAS score of at least 40 mm in the upper extremity to avoid flooring effect for injection-related pain reduction

Exclusion Criteria

1. Uncontrolled hypertension (>180/110)

2. Sepsis

3. Bleeding diathesis

4. Active cancer

5. Brachial plexus injuries

6. Neurological language deficits precluding participation

7. Mini mental state examination score < 23

8. Acute mental illness (An acute mental illness is characterized by clinically significant symptoms of any metal health illness that requires immediate treatment. The physician making the recommendation to be part of the study. If the patient exhibits symptoms of any mental health illness that is not being treated by either the recommending physician or another member of the patient's care team the patient will not be recommended to participate in the study)

9. Patients who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

Elisabeth Bruyere Hospital and The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Elisabeth Bruyere Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20200600-01H

Identifier Type: -

Identifier Source: org_study_id