NCT Number: NCT04744675
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 2
Elisabeth Bruyere Hospital, Ottawa, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Kenalog
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.
Bupivacaine is an anesthetic that is commonly used as a local numbing agent, including intramuscular, intra-articular and intrabursal injections.
Other names: Marcaine
Time frame: Week -2
Number of participants who are successfully recruit into the study.
Time frame: Week 0
Number of participants who accept being randomized into either the intervention or placebo treatment arms and receive the injection accordingly.
Time frame: 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).
Time frame: Week 2
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).
Time frame: Week 6
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Week 6
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).
Time frame: 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).
Time frame: Week 12
The percentage of participants who remained in the study for the entire duration of their planned involvement.
Time frame: Week 12
The percentage of participants who complete all of the study questionnaires
Time frame: Week 12
We will track adverse events the participants experience
Time frame: 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
Time frame: Week 0 - Immediately before injection
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
Time frame: Week 0 - Immediately after injection
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
Time frame: 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
Time frame: Week 6
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
Time frame: 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
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
Ottawa Hospital Research Institute
Other
Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome: a Feasibility Study for a Proposed Randomized Design
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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