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Musculoskeletal PainNCT04683263

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

A study testing Fisiocrem in people with Musculoskeletal Pain and Chronic Pain, run by Uriach Consumer Healthcare at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Pain, Chronic Pain, Joint Pain
What is being tested?
Fisiocrem
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteSpain
Study dates
1 Jun 2019to 20 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • acute or chronic musculoskeletal pain scoring above 4 in the Visual Analogue Scale (VAS)
  • diagnostic of either tendinopathy, vertebral algias, sprains or symptomatic osteoarthritis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • QuironSalud Hosiptal

    Barcelona, 08023

Other trials in Spain

About this study

Official title: Immediate and Mid-term Effect of a Natural Topical Product in Patients With Musculoskeletal Pain: a Randomized, Double-blinded, and Placebo-controlled Clinical Trial.

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.

Read more

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.

Being tested
Placebo, Fisiocrem
Keywords
Musculoskeletal pain, Chronic pain, Joint mobility, Massage, Rehabilitation
Medical subject headings
Musculoskeletal Pain, Chronic Pain, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    topical cream with same composition as Intervention but without active ingredients

  • FisiocremOther

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

Study groups in NCT04683263
Study groupRoleWhat they receive
InterventionActive comparatorFisiocrem®, a topical cream composed of the natural ingredients Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and menthol
Receives: Other: Fisiocrem
PlaceboPlacebo comparatortopical cream with similar characteristics and aspect, without active ingredients.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: 14 days (0, 7 and 14 days)

Secondary outcomes (8)
  1. Average variation in pain at rest

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

    Measured: 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)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.)

    Measured: 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

    Measured: 14 days (0, 7 and 14 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start1 Jun 2019
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, double-blinded and placebo-controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683263
Sponsor's protocol ID
07CRT_VV_323_18-003
Status last verified
Feb 2021
First submitted
20 Dec 2020
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fisiocrem in people with Musculoskeletal Pain and Chronic Pain, run by Uriach Consumer Healthcare at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average variation in pain at rest (time frame: 14 days (0, 7 and 14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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