Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744675
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2021-01-21
Brief Title:
Peripheral Nerve Injections for CRPS
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome a Feasibility Study for a Proposed Randomized Design
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
Not yet recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Complex regional pain syndrome CRPS is characterized by intense pain loss of function and associated with motor trophic sudomotor andor 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 ie 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None