RESUMO
STUDY OBJECTIVES: Cannabidiol (CBD) is increasingly used as a health supplement, though few clinical studies have demonstrated benefits. The primary objective of this study was to evaluate the effects of an oral CBD-terpene formulation on sleep physiology in individuals with insomnia. METHODS: In this double-blind, placebo-controlled, randomized clinical trial, 125 individuals with insomnia received an oral administration of CBD (300 mg) and terpenes (1 mg each of linalool, myrcene, phytol, limonene, α-terpinene, α-terpineol, α-pinene, and ß-caryophyllene) for ≥ 4 days/week over 4 weeks using a crossover design. The study medication was devoid of Δ9-tetrahydrocannabinol (Δ9-THC). The primary outcome measure was the percentage of time participants spent in the combination of slow wave sleep (SWS) and rapid eye movement (REM) sleep stages, as measured by a wrist-worn sleep-tracking device. RESULTS: This CBD-terpene regimen marginally increased the mean nightly percentage of time participants spent in SWS + REM sleep compared to the placebo [mean (SEM), 1.3% (0.60%), 95% C.I. 0.1 to 2.5%, P = 0.03]. More robust increases were observed in participants with low baseline SWS + REM sleep, as well as in day sleepers. For select participants, the increase in SWS + REM sleep averaged as much as 48 minutes/night over a four-week treatment period. This treatment had no effect on total sleep time (TST), resting heart rate or heart rate variability, and no adverse events were reported. CONCLUSIONS: Select CBD-terpene ratios may increase SWS + REM sleep in some individuals with insomnia, and may have the potential to provide a safe and efficacious alternative to over-the-counter (OTC) sleep aids and commonly prescribed sleep medications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT05233761.
RESUMO
Following cervical spine fusion there is a reduction in maximum range of motion (ROM) but how this impacts activity of daily living (ADLs) and quality of life is unknown. This study's purpose is to quantify maximum and functional cervical spine ROM in patients with multi-level cervical fusion (>3 levels) compared to controls during ADLs and to correlate functional range of motion with scores from patient reported outcomes measures (PROs) including the Comparative Pain Scale (CPS), Fear Avoidance Belief Questionnaire (FABQ), and Neck Disability Index (NDI). An inertial measurement unit (IMU) system quantified ROM during ADLs in the extension/flexion, lateral bending, and axial rotation directions of motion. The reliability of this system was compared to standard optical motion tracking. Fourteen participants (8 females, age = 60.0 years (18.7) (median, (interquartile range)) with a history of multi-level cervical fusion (years post-op 0.9 (0.7)) were compared to 16 controls (13 females, age = 52.1 years (15.8)). PROs were collected for each participant. Fusion participants had significantly decreased maximum ROM in all directions of motion. Fusion participants had decreased ROM for some ADLs (backing up a car, using a phone, donning socks, negotiating stairs). CPS, FABQ, and NDI scores were significantly increased in fusion participants. Reductions in two activities (backing up a car, stair negotiation) correlated with a combination of increased PRO scores. Cervical fusion decreases maximum ROM and is correlated with increased PROs in some ADLs, however there is minimal impact on functional ROM. Investigation into velocity and acceleration may yield categorization of pathologic movement.