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According to the latest Global Burden of Disease Study (2017), musculoskeletal conditions are a major cause of disability worldwide and is the primary cause of disability among members of the economically productive age group (ages 20 to 64 years) (IHME, 2018). Pain as a result of these musculoskeletal conditions causes diminished quality of life and increased demands on healthcare (Vos et al., 2013; Wool & Pfleger, 2003).
The management of musculoskeletal pain includes a wide range of treatment modalities, such as non-pharmacological treatments, complementary therapies, and pharmacological interventions (Babatunde et al., 2017; Cameron & Chrubasik, 2013). The latter could include analgesics, non-steroidal anti-inflammatory drugs, corticosteroid injections, and topical therapies. Topical therapies, in particular, may include topical analgesics, capsaicin, and liniments, embrocations, and other counterstimulants (Derry et al., 2014; Mason et al., 2004). These agents can be used to treat pain in a wide variety of clinical scenarios, such as first-line treatment for localized and/or non-serious pain, as adjuvants to other therapies (e.g., oral analgesics, support bandages, rest, ice and compression), and for patients who dislike or cannot tolerate oral analgesics (Mason et al., 2004).
A number of systematic reviews have evaluated the efficacy and safety of topical counterstimulants in the treatment of musculoskeletal pain. A Cochrane review analyzed data from six placebo‐ and one active‐controlled studies (n=560 and 137, respectively) on acute pain, and seven placebo‐ and three active‐controlled studies (n=489 and 182, respectively) on chronic pain. In this review, salicylate-containing topical compounds had higher clinical success rates at 7 days for acute pain compared with placebo (RR 1.9; 95% CI 1.5 to 2.5; NNT 3.2; 95% CI 2.4 to 4.9) for salicylates compared with placebo (Derry et al., 2014). The respective RR for chronic pain was 1.6 (95% CI 1.2 to 2.0), with an NNT of 6.2 (95% CI 4.0 to 13). However, local adverse events at the application site were more common with active topical therapy compared with placebo).
the Study Treatment (Study Treatment) is a topical treatment in gel (Study Gel) or spray (Study Spray) format which contains a proprietary combination of menthol and herbal extracts of Pinus sylvestris, Citrus aurantium dulcis, Gaultheria procumbens, Citrus aurantium bergamia, Citrus medica limonum, Rosmarinus officinalis and Lavandula angustifolia. This combination produces a warming/cooling sensation, which may be beneficial in the management of musculoskeletal pain through counterstimulation and the promotion of muscle relaxation (Andrea, 2018). A randomized controlled trial that included 54 office employees found that the Study Treatment, when used in conjunction with stretching, isometric and strengthening exercises, was useful in the treatment of headache and shoulder and neck pain (Burlet & Christine 2006). In this study, patients on the Study Treatment experienced a mean reduction in pain intensity that was correlated with continued and consistent use of the Study Treatment for 3 months (r=0.502; p=0.006). The study also concluded that the Study Treatment contributed to the physiotherapeutic management of headache and shoulder and neck pain.