Complex Regional Pain Syndromes
Conditions
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.
Interventions
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.
DRUGSaline 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.
DRUGBupivacaine
Bupivacaine is an anesthetic that is commonly used as a local numbing agent, including intramuscular, intra-articular and intrabursal injections.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 0 | 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 2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - EQ-5D-5L | Week -2 | 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. |
| Pain - Visual Analog Scale | Week -2 | 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 |
| Total Score - EQ-5D-5L | Week -2 | 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. |
| Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2 | Week -2 | 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 -2 | 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 -2 | 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 -2 | 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 -2 | 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 -2 | 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 -2 | 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. |
Countries
Canada
Outcome results
None listed