Peripheral Nerve Injections for CRPS
- Conditions
- Complex Regional Pain Syndromes
- Interventions
- Registration Number
- NCT04744675
- Lead Sponsor
- Ottawa Hospital Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Able to provide signed and dated informed consent form
- Male or female, aged ≥18 years old
- Satisfy the Budapest Criteria for upper extremity CRPS
- A VAS score of at least 40 mm in the upper extremity to avoid flooring effect for injection-related pain reduction
- Uncontrolled hypertension (>180/110)
- Sepsis
- Bleeding diathesis
- Active cancer
- Brachial plexus injuries
- Neurological language deficits precluding participation
- Mini mental state examination score < 23
- 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)
- Patients who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Saline Injection 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 Triamcinolone Acetonide 40mg/mL 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 Treatment Bupivacaine 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
- Primary Outcome Measures
Name Time Method Recruitment Week -2 Number of participants who are successfully recruit into the study.
Randomization Week 0 Number of participants who accept being randomized into either the intervention or placebo treatment arms and receive the injection accordingly.
Blinding - Participant Week 12 The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Interventionist Week 0 The interventionist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Physiotherapist Week 12 The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Retention Week 12 The percentage of participants who remained in the study for the entire duration of their planned involvement.
Data completion Week 12 The percentage of participants who complete all of the study questionnaires
Rate of Adverse events Week 12 We will track adverse events the participants experience
- Secondary Outcome Measures
Name Time Method Pain - Visual Analog Scale Week 12 We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2 Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 4 and the highest possible score is 30, and a higher score indicates a worse outcome.
Pain - EQ-5D-5L Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Disease Severity - Complex Regional Pain Syndrome Severity Score Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 17, and a higher score indicates a worse outcome.
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 100, and a higher score indicates a worse outcome.
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2 Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 8 and the highest possible score is 40, and a higher score indicates a better outcome.
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2 Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 16 and the highest possible score is 80, and a higher score indicates a worse outcome.
Emotional and Psychological Function - EQ-5D-5L Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Quality of Life - EQ-5D-5L Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Total Score - EQ-5D-5L Week 12 These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 5 and the highest possible score is 25, and a higher score indicates a worse outcome.
Trial Locations
- Locations (2)
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Elisabeth Bruyere Hospital
🇨🇦Ottawa, Ontario, Canada