Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04683263 |
Other study ID # |
07CRT_VV_323_18-003 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2019 |
Est. completion date |
December 20, 2019 |
Study information
Verified date |
February 2021 |
Source |
Uriach Consumer Healthcare |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.