A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Thumb Basal Joint Arthritis.

PURPOSE: Since the passage of the Agricultural Improvement Act of 2018, hand surgeons have increasingly encountered patients seeking counseling on over-the-counter, topical cannabidiol (CBD) for the treatment of pain. To this end, we designed a human clinical trial to investigate the therapeutic potential of CBD for the treatment of pain associated with thumb basal joint arthritis. METHODS: Following Food and Drug Administration and institutional approval, a phase 1 skin test was completed with 10 healthy participants monitored for 1 week after twice-daily application of 1 mL of topical CBD (6.2 mg/mL) with shea butter. After no adverse events were identified, we proceeded with a phase 2, double-blinded, randomized controlled trial. Eighteen participants with symptomatic thumb basal joint arthritis were randomized to 2 weeks of twice-daily treatment with CBD (6.2 mg/mL CBD with shea butter) or shea butter alone, followed by a 1-week washout period and then crossover for 2 weeks with the other treatment. Safety data and physical examination measurements were obtained at baseline and after completion of each treatment arm. RESULTS: Cannabidiol treatment resulted in improvements from baseline among patient-reported outcome measures, including Visual Analog Scale pain; Disabilities of the Arm, Shoulder, and Hand; and Single Assessment Numeric Evaluation scores, compared to the control arm during the study period. There were similar physical parameters identified with range of motion, grip, and pinch strength. CONCLUSIONS: In this single-center, randomized controlled trial, topical CBD treatment demonstrated significant improvements in thumb basal joint arthritis-related pain and disability without adverse events. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.

Cannabinoids and Pain for the Plastic Surgeon: What Is the Evidence?

BACKGROUND: Since the passage of the 2018 Farm Bill, practitioners have encountered more patients self-treating pain with over-the-counter topical cannabidiol (CBD) derived from hemp-Cannabis sativa with less than 0.3% delta-9-tetrahydrocannabinol-with reported improvements in pain control and activities of daily living. Cannabidiol has been touted for its capacity to improve inflammatory, arthritic, and neuropathic pain conditions, and increasing numbers of patients are exploring its use as potential replacement for opioids. However, limited rigorous clinical trials have been performed evaluating the safety and efficacy of cannabinoids for the treatment of pain. METHODS: A systematic search of PubMed was performed using the Medical Subject Headings (MeSH) terms "cannabinoid" or "CBD" or "cannabidiol" or "cannabis" or "medical marijuana" and "pain." It yielded 340 article titles. Twelve full-text primary studies of oral or topical CBD for chronic pain were selected for review, including 6 animal (2 randomized clinical trial and 4 prospective trials) and 6 human (4 randomized clinical trial and 2 prospective trials) studies. RESULTS: With respect to the safety and efficacy of oral and topical CBD for treating pain, animal and human studies have shown early positive results with limited minor side effects. However, all human studies may be underpowered with small sample sizes. CONCLUSIONS: With respect to the safety and efficacy of oral and topical CBD for treating pain, the evidence remains inconclusive in that we have a paucity of data to share with our patients who are considering the use of these products, which may be associated with significant costs.

Patient-Generated Actigraphy Data as a Novel Outcomes Instrument in Carpal Tunnel Syndrome.

BACKGROUND: Currently, we lack objective measures to quantify outcomes in carpal tunnel syndrome. Instead, surgeons rely on patient-reported outcomes measures (PROMs) to assess the effect of carpal tunnel release (CTR). We assessed the validity and reliability of wearable activity monitors to objectively characterize the functional and sleep impact of CTR. We hypothesized that actigraphy could detect changes in sleep and activity and would demonstrate short-term impairment due the operative procedure. METHODS: This pilot, prospective, cohort study compared validated PROMS with actigraphy data obtained via wearable activity monitors (ActiGraph Link; ActiGraph Corp, Pensacola, Fla). Subjects completed baseline questionnaires and wore their device for 1 week preoperatively as a baseline. Subjects then underwent open CTR, wearing actigraphy devices for 4 weeks and completing questionnaires at 2 and 4 weeks postoperatively. Preintervention and postintervention data were compared using paired-sample t test. The Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire data were analyzed in accordance with published PROMIS scoring manuals and raw scores were converted to standardized T scores. RESULTS: Twenty subjects (5 males, 15 females) with moderate or severe carpal tunnel syndrome were enrolled. The mean age was 57.7 years. The PROMIS 29 average cumulative T score was 42.9 with average change of -0.072 preoperatively versus postoperatively. Average sleep disturbance T score was 38.9 preoperatively and 41.4 postoperatively. There was no statistically significant difference in T score in any domain. The mean actigraphy activity data demonstrated near immediate return to baseline activity. Actigraphy sleep data demonstrate improvement in sleep fragmentation and decreased duration of awakenings. CONCLUSIONS: Overall, patient-generated data detected differences in sleep and activity preoperatively versus postoperatively and demonstrated only a short period of activity disruption after CTR, which may be used when counseling patients. These data support actigraphy as a viable adjunct to traditional PROMS to evaluate the impact of surgical intervention and therefore may be useful in the study of other diseases affecting the upper extremity.

Nutritional armor for the injured warfighter: omega-3 fatty acids in surgery, trauma, and intensive care.

Nutrients have traditionally been viewed as a means to provide basic energy for cellular homeostasis and amino acids for protein synthesis in all humans. Young, healthy men and women in the military today are presumed to be well nourished and mentally and physically fit to perform their duties in austere environments. Exposure to high-intensity projectiles, blast injuries, and other wounds of war, however, is an everyday occurrence during deployment that potentially challenges all homeostatic mechanisms. After sustaining such devastating injuries, critically ill, surgical, and trauma patients are in a constant dynamic state between the systemic inflammatory response syndrome (and compensatory anti-inflammatory response syndrome. Compelling evidence supports both immune and metabolic response modulation by specific nutrients, including omega-3 fatty acids, primarily eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). The concept of providing nutrients as therapeutic rather than supportive agents to meet the basic cellular caloric and metabolic demands requires a major paradigm shift. Although the exact route and dose of these metabolically active lipids has yet to be determined, data from large clinical studies of cellular ex-vivo experiments in patients support the liberal use of eicosapentaenoic acid and docosahexaenoic acid in the setting of trauma, surgery, and intensive care.