In Brazil, 27 million people suffer from chronic back pain — and clinical study with cannabis extract shows pain reduction, improved sleep, and physical function

Chronic back pain is one of the most prevalent health conditions affecting adults in Brazil, impacting approximately 27 million individuals aged 18 and older, according to the National Health Survey (PNS). The survey indicates that 18.5% of the population in this age group has received a medical diagnosis of chronic back issues — with a higher incidence among women, the elderly, and individuals with lower levels of education.

The condition is associated with functional limitations, mobility impact, and difficulties in sleeping, ranking among the main causes of disability and work absenteeism in the country. In many cases, the available pharmacological treatments have limited efficacy and adverse effects with prolonged use.

In this scenario, results from a phase 3 clinical trial with a standardized cannabis extract suggest a potential therapeutic alternative for patients with chronic low back pain.

Clinical Study

German pharmaceutical company Vertanical conducted a multicenter, randomized, double-blind, placebo-controlled study to evaluate the experimental product VER-01, a standardized extract of Cannabis sativa with a defined content of tetrahydrocannabinol (THC), in adults with chronic low back pain. The results were published in the scientific journal Nature Medicine.

The study included 820 participants in the 12-week phase, with additional follow-up in long-term open-label phases, totaling up to 12 months of clinical observation.

Significant Pain Reduction

The trial achieved its primary outcome by demonstrating that patients treated with Vertanical's extract showed a greater reduction in pain intensity compared to the placebo group. The difference was statistically significant at the end of the double-blind period.

The analgesic effects were observed over the initial 12 weeks and persisted in subsequent phases, with an increase in the proportion of patients achieving clinically relevant pain reduction.

Impact on Sleep, Physical Function, and Neuropathic Symptoms

Among the secondary outcomes assessed, patients treated with the cannabis extract reported improvements in sleep quality and functional capacity for daily activities, measured by disability scales related to low back pain.

In participants with a neuropathic component, there was a more pronounced reduction in symptoms, including burning, tingling, and shock-like pain, compared to the placebo group.

Patients in the active group also used less rescue medication throughout the study.

Safety and Tolerability Profile

Vertanical's experimental product was well tolerated by the majority of participants. The reported adverse events were generally mild to moderate and occurred more frequently at the beginning of the titration period.

The most common effects included dizziness, drowsiness, and fatigue. There were no signs of dependence, abuse, or withdrawal symptoms during the follow-up. Additionally, there were no clinically relevant changes in laboratory tests or cardiovascular parameters.

Scientific Publication

The clinical study conducted by Vertanical was published in the journal Nature Medicine and is available HERE.