A new study finds that an oral tablet containing cannabidiol (CBD) effectively reduces pain after shoulder surgery with no safety concerns.
Researchers from the Department of Orthopaedic Surgery at NYU Langone Health found that the tablet ORAVEXXTM managed pain after a shoulder surgery known as rotator cuff surgery. They further found that it did not produce side effects that can be associated with CBD use, such as nausea, anxiety, and liver toxicity.
“There is an urgent need for viable alternatives for pain management, and our study presents this form of CBD as a promising tool after arthroscopic rotator cuff repair,” said lead investigator Michael J. Alaia, MD, associate professor in the Department of Orthopaedic Surgery at NYU Langone Health. “It could be a new, inexpensive approach for delivering pain relief, and without the side effects of anti-inflammatory drugs like NSAIDs and addiction risks linked to opiates. Additionally, CBD has the benefit of pain relief without the psychotropic effects associated with THC or marijuana.”
The findings were presented at the American Academy of Orthopaedic Surgeons (AAOS) 2022 Annual Meeting in Chicago.
Trialling ORAVEXXTM after shoulder surgery
The multicentre Phase 1/2 clinical trial randomly sorted 99 participants across two study sites – NYU Langone Health and Baptist Health/Jacksonville Orthopaedic Institute – between the ages of 18 and 75 into a placebo group and a group receiving oral-absorbed CBD. Participants have been prescribed a low dose of Percocet, instructed to warn off the narcotic as soon as possible and to take the placebo/CBD three times a day for 14 days after their shoulder surgery.
On the first day following the shoulder surgery, patients receiving CBD experienced on average 23% less pain according to the Visual Analog Scale (VAS) pain score compared to patients receiving the placebo. This indicated that patients with moderate pain following shoulder surgery could benefit from the CBD medication.
Further findings indicate that on the first and second days after surgery, patients in the CBD group reported a 22-25% greater satisfaction with pain control compared to the placebo group. In-depth analysis revealed that patients receiving 50mg of CBD reported lower pain and higher satisfaction with pain control compared to patients receiving the placebo.
The researcher’s results are promising however, Dr Alaia cautioned consumers against seeking out commercialised CBD products.
“Our study is examining a well-designed, carefully scrutinised product under an investigational new drug application sanctioned by the FDA. This is currently still experimental medicine and is not yet available for prescription,” he added.
NYU Langone Health has launched a second study looking at whether ORAVEXXTM can specifically treat chronic pain in patients with osteoarthritis. Multiple Phase 2 studies also are planned to evaluate the drug’s efficacy for other acute and chronic pain management issues and assess the role of CBD on inflammation.