The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities. The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
Complex Regional Pain Syndrome (CRPS) is a debilitating and perplexing chronic pain condition that produces incalculable suffering to millions of individuals worldwide. The enigmatic nature of CRPS has left it difficult to treat. CRPS is characterized by a constellation of pain, sensory, autonomic, and motor symptoms that is difficult to pinpoint the source of injury/inflammation. Although unclear, a common cause of CRPS are radial fractures that demonstrate aberrant processing 4-6 weeks after injury. The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities. The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
BRC-002 is a non-scheduled cannabidiolic (CBD) formulation (\<.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant as acidic forms of CBD (cannabidiolic acid; CBDA), THC (tetrahydrocannabinolic acid; THCA) and other minor cannabinoids.
Oral solution of mono-, di-, and triglycerides
Altman Clinical and Translational Research Institute
La Jolla, California, United States
RECRUITINGUniversity of California, San Diego
San Diego, California, United States
RECRUITINGChange in complex regional pain syndrome pain and heat pain measured with VAS
Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain
Time frame: Day 1 - Day 42
Pain Inventory Measure
Change from baseline in The Brief Pain Inventory
Time frame: Day 1 - Day 42
Depression Measure
Change from baseline in Beck Depression
Time frame: Day 1 - Day 42
Sleep Measure
Change from baseline in Pittsburgh Sleep Quality Index
Time frame: Day 1 - Day 42
Interleukin 6
Change from baseline in Interleukin 6
Time frame: Day 1 - Day 42
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