CClinicalTrials.gg
CompletedNCT04683263Updated Feb 8, 2021

Immediate and Mid-term Effect of a Natural Topical Product in Patients With Musculoskeletal Pain

An interventional study of Placebo and Fisiocrem in Musculoskeletal Pain, Chronic Pain and Joint Pain, sponsored by Uriach Consumer Healthcare. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.

Sponsored by Uriach Consumer Healthcare · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jun 2019, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Musculoskeletal Pain
  • Chronic Pain
  • Joint Pain
  • Stiffness of Unspecified Joint, Not Elsewhere Classified

Keywords

  • Musculoskeletal pain
  • Chronic pain
  • Joint mobility
  • Massage
  • Rehabilitation
03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 114 are open to participants now.

This study's enrollment of 200 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Uriach Consumer Healthcare is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • diagnostic in either neuropathic chronic pain, fibromyalgia or neoplasia
  • allergy to any ingredient in the formula
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Intervention

    Fisiocrem®, a topical cream composed of the natural ingredients Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and menthol

    Other: Fisiocrem

  • Placebo comparator
    Placebo

    topical cream with similar characteristics and aspect, without active ingredients.

    Other: Placebo

Interventions

  • OtherPlacebo

    topical cream with same composition as Intervention but without active ingredients

  • OtherFisiocrem

    a natural topical composition containing Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and menthol

06

What researchers measure

Primary outcomes

  1. Average variation in pain at rest

    pain reduction after intervention measured as per a Visual Analog Scale (1 - 10, higher values indicating more pain)

    Time frame: 14 days (0, 7 and 14 days)

  2. Average variation in pain in motion

    pain reduction after intervention measured as per a Visual Analog Scale (1 - 10, higher values indicating more pain)

    Time frame: 14 days (0, 7 and 14 days)

Secondary outcomes

  1. Average variation in pain at rest

    pain reduction after intervention measured as per a Faces Scale (1 - 10, higher values indicating more pain)

    Time frame: 2 hours (0, 30 minutes, 1 hour, 2 hours)

  2. Average variation in pain in motion

    pain reduction after intervention measured as per a Faces Scale (1 - 10, higher values indicating more pain)

    Time frame: 2 hours (0, 30 minutes, 1 hour, 2 hours)

  3. Average variation in stiffness at rest

    stifness reduction after intervention measured as per a Stifness scale - (0) no stiffness, (1) slight stiffness, (2) moderate stiffness and (3) severe stiffness.

    Time frame: 2 hours (0, 30 minutes, 1 hour, 2 hours)

  4. Average variation in stiffness in motion

    stifness reduction after intervention measured as per a Stifness scale - (0) no stiffness, (1) slight stiffness, (2) moderate stiffness and (3) severe stiffness.

    Time frame: 2 hours (0, 30 minutes, 1 hour, 2 hours)

  5. Average variation in stiffness at rest

    stifness reduction after intervention measured as per a Stifness scale -- (0) no stiffness, (1) slight stiffness, (2) moderate stiffness and (3) severe stiffness.

    Time frame: 14 days (0, 7 and 14 days)

  6. Average variation in stiffness in motion

    stifness reduction after intervention measured as per a Stifness scale - (0) no stiffness, (1) slight stiffness, (2) moderate stiffness and (3) severe stiffness.

    Time frame: 14 days (0, 7 and 14 days)

  7. Recovery perception

    Subjective perception of recovery as per a Likert scale ((1) meant fully recovered, (2) much better, (3) better, (4) same as before and (5) worse than before.)

    Time frame: 14 days (0, 7 and 14 days)

  8. Joint mobility

    Joint mobility evaluation as per passive joint balance ((1) free mobility, (2) partial limitation, (3) moderate limitation and (4) severe limitation

    Time frame: 14 days (0, 7 and 14 days)

07

Study locations

1 site
  • QuironSalud Hosiptal
    Barcelona, 08023, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04683263
Lead sponsor
Uriach Consumer Healthcare
Collaborators
Quironsalud
Responsible party
Sponsor
First posted
Dec 24, 2020
Start date
Jun 1, 2019
Primary completion
Dec 20, 2019
Completion
Dec 20, 2019
Last update
Feb 8, 2021

Study contacts

Silvia Ramon, MD, PhD
principal investigator · Hospital QuiroSalud Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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