Clinical trial NCT04744675: Peripheral Nerve Injections for CRPS
Official title: Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome: a Feasibility Study for a Proposed Randomized Design
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recruitment
timeFrame: Week -2
measure: Randomization
timeFrame: Week 0
measure: Blinding - Participant
timeFrame: Week 0
measure: Blinding - Participant
timeFrame: Week 2
measure: Blinding - Participant
timeFrame: Week 6
measure: Blinding - Participant
timeFrame: Week 12
measure: Blinding - Interventionist
timeFrame: Week 0
measure: Blinding - Physiotherapist
timeFrame: Week 2
measure: Blinding - Physiotherapist
timeFrame: Week 6
measure: Blinding - Physiotherapist
timeFrame: Week 12
measure: Retention
timeFrame: Week 12
measure: Data completion
timeFrame: Week 12
measure: Rate of Adverse events
timeFrame: Week 12
Secondary outcomes:
measure: Pain - Visual Analog Scale
timeFrame: Week -2
measure: Pain - Visual Analog Scale
timeFrame: Week 0 - Immediately before injection
measure: Pain - Visual Analog Scale
timeFrame: Week 0 - Immediately after injection
measure: Pain - Visual Analog Scale
timeFrame: Week 2
measure: Pain - Visual Analog Scale
timeFrame: Week 6
measure: Pain - Visual Analog Scale
timeFrame: Week 12
measure: Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week -2
measure: Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 0
measure: Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 2
measure: Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 6
measure: Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 12
measure: Pain - EQ-5D-5L
timeFrame: Week -2
measure: Pain - EQ-5D-5L
timeFrame: Week 0
measure: Pain - EQ-5D-5L
timeFrame: Week 2
measure: Pain - EQ-5D-5L
timeFrame: Week 6
measure: Pain - EQ-5D-5L
timeFrame: Week 12
measure: Disease Severity - Complex Regional Pain Syndrome Severity Score
timeFrame: Week -2
measure: Disease Severity - Complex Regional Pain Syndrome Severity Score
timeFrame: Week 0
measure: Disease Severity - Complex Regional Pain Syndrome Severity Score
timeFrame: Week 2
measure: Disease Severity - Complex Regional Pain Syndrome Severity Score
timeFrame: Week 6
measure: Disease Severity - Complex Regional Pain Syndrome Severity Score
timeFrame: Week 12
measure: Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: Week -2
measure: Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: Week 0
measure: Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: Week 2
measure: Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: Week 6
measure: Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
timeFrame: Week 12
measure: Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week -2
measure: Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 0
measure: Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 2
measure: Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 6
measure: Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 12
measure: Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week -2
measure: Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 0
measure: Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 2
measure: Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 6
measure: Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
timeFrame: Week 12
measure: Emotional and Psychological Function - EQ-5D-5L
timeFrame: Week -2
measure: Emotional and Psychological Function - EQ-5D-5L
timeFrame: Week 0
measure: Emotional and Psychological Function - EQ-5D-5L
timeFrame: Week 2
measure: Emotional and Psychological Function - EQ-5D-5L
timeFrame: Week 6
measure: Emotional and Psychological Function - EQ-5D-5L
timeFrame: Week 12
measure: Quality of Life - EQ-5D-5L
timeFrame: Week -2
measure: Quality of Life - EQ-5D-5L
timeFrame: Week 0
measure: Quality of Life - EQ-5D-5L
timeFrame: Week 2
measure: Quality of Life - EQ-5D-5L
timeFrame: Week 6
measure: Quality of Life - EQ-5D-5L
timeFrame: Week 12
measure: Total Score - EQ-5D-5L
timeFrame: Week -2
measure: Total Score - EQ-5D-5L
timeFrame: Week 0
measure: Total Score - EQ-5D-5L
timeFrame: Week 2
measure: Total Score - EQ-5D-5L
timeFrame: Week 6
measure: Total Score - EQ-5D-5L
timeFrame: Week 12
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Elisabeth Bruyere Hospital
state: Ontario
Study officials:
affiliation: Elisabeth Bruyere Hospital and The Ottawa Hospital
name: Mark Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: