Immediate and Mid-term Effect of a Natural Topical Product in Patients With Musculoskeletal Pain
Immediate and Mid-term Effect of a Natural Topical Product in Patients With Musculoskeletal Pain
Musculoskeletal pain is a common affection due to ageing, sedentarism and intense exercise
 practice causing acute and chronic injuries.

 The main objective of this trial is to prove efficacy of a natural topical composition
 containing Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and
 menthol in pain management in adults with acute or chronic pain.

 This randomized, double-blinded and placebo-controlled trial will include 200 patients with
 musculoskeletal pain, 100 in the intervention group receiving the topical formula and 100 in
 the placebo group, who will receive a similar formula without active ingredients.

 The products will be applied topically twice daily for 14 days in areas with moderate or
 severe pain.

 The study objectives are immediate and long-term pain alleviation, stiffness perception joint
 mobility, and general recovery perception.
Well-being is understood as the absence of limitations or debilitating conditions that make
 impossible to enjoy a full and satisfactory life. Among these limitations, a reduced or
 impaired motility because of painful and inflammatory processes (acute and chronic), can
 greatly disturb a vital and optimistic attitude.

 Chronic pain affects between one-third and one-half of the population only in the UK, and
 around 20.4% in the US. It is likely to increase with population ageing and tends to be more
 common in women. Ageing is translated in an increase in the incidence and span of chronic
 illnesses, including osteoarthritis, fibromyalgia, lower back pain, non-arthritis joint pain
 or carpal tunnel syndrome, among others. In addition, muscular and joints pain unrelated to
 any specific disease also tends to appear with age. Beyond that, current lifestyle frequently
 involves stressful jobs, eventful agendas and non-stop activity either in professional or
 leisure time. These facts extend the prevalence of chronic pain to younger segments of the
 population and to people not affected by previous disease.

 Sedentary lifestyle and computer-based jobs represent a common cause of muscular contractures
 and pain, especially in the back and neck areas. Another important contributor to chronic
 pain is perceived stress and anxiety response systems. As an emergent antagonist phenomenon,
 increasing awareness of a healthy lifestyle has entailed a rise in the popularity of physical
 exercise in the last decades. As an example, the number of running events finishers in the
 U.S. stabilized in 2014 at almost 20 million people, with figures having been on the rise for
 the previous 25 years. The popularization of exercise programs such as CrossFit illustrate
 that the trend is directed not only towards a rise in practice, but also in intensity. Thus,
 the increase in the practice of high-intensity physical activity and the alternation between
 sedentary and exercise periods involve an increase in inflammatory and acute painful
 episodes, being tendinitis and joint lesions the major problem, followed by sprains or
 bruises.

 The pharmacological management of these conditions involves nonsteroidal anti-inflammatory
 drugs (NSAIDs), local corticosteroids, acetaminophen, chondroitin sulfate or even opioids.
 These are effective drugs but with serious side effects in some cases, especially in the
 long-term utilization. Severe drawbacks related to the prolonged utilization of these drugs
 include drug ineffectiveness, toxicity of certain agents, hypersensitivity, gastrointestinal
 hemorrhage, nauseas and even fatal outcomes including death and suicide. Importantly,
 increased abuse of painkillers has been reported in several countries, exceeding tobacco
 consumption and being considered a public health problem. Furthermore, the use of painkillers
 should be avoided in sensitive population groups including children and pregnant women, who
 are equally exposed to sustained or acute pain episodes.

 Alternative solutions of greater safety but equivalent rapid relief and recovery
 effectiveness are a necessity. In this sense, the most useful approach are natural products,
 without tolerability concerns, compatible with other interventions and providing a rapid
 effect. These generalize access to effective treatment to both patients and physiotherapy
 professionals. Considering the well-established beneficial effects of physiotherapy in
 handling chronic pain, professionals need effective and safe solutions that they can use
 without concerns of side effects or pharmacological interactions, since they may not have
 access to the full medical record of the patients. In turn, the ability of handling
 self-treatment without concern increases the quality of life in patients suffering from
 pain-involving conditions.

 This study evaluates the use of a topical cream composed by natural extracts with
 complementary and synergistic effects for pain management. Menthol reduces pain and increases
 blood flow, warming up the muscle and enhancing absorption of the rest of the extracts.
 Arnica montana reduces pain, has anti-inflammatory effects and potentiates tissue repair.
 Hypericum perforatum provides anti-inflammatory effect and drives tissue regeneration and
 scarring. Calendula officinalis reduces swelling and distension, boosts healing of mild
 injuries and prevents infection. Finally, Melaleuca alternifolia complements the
 anti-inflammatory effect and acts as a natural preservative due to its potent antimicrobial
 effect.

 The synergistic combination of these natural ingredients may provide a convenient solution
 for the management acute or chronic pain. The aim of this study is to assess the benefits of
 the topical formulation in reducing musculoskeletal pain, both as an immediate relief of pain
 and as a solution for injury recovery.
Inclusion Criteria:

 -  acute or chronic musculoskeletal pain scoring above 4 in the Visual Analogue Scale
 (VAS)

 -  diagnostic of either tendinopathy, vertebral algias, sprains or symptomatic
 osteoarthritis

 Exclusion Criteria:

 -  diagnostic in either neuropathic chronic pain, fibromyalgia or neoplasia

 -  allergy to any ingredient in the formula