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

NCT04683263 | Completed

• 1 other identifier: 07CRT_VV_323_18-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Musculoskeletal pain; Chronic pain; Joint mobility; Massage; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Average variation in pain at rest

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

  14 days (0, 7 and 14 days)

• Average variation in pain in motion

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

  14 days (0, 7 and 14 days)

Secondary Outcomes (8)

• Average variation in pain at rest

  2 hours (0, 30 minutes, 1 hour, 2 hours)

• Average variation in pain in motion

  2 hours (0, 30 minutes, 1 hour, 2 hours)

• Average variation in stiffness at rest

  2 hours (0, 30 minutes, 1 hour, 2 hours)

• Average variation in stiffness in motion

  2 hours (0, 30 minutes, 1 hour, 2 hours)

• Average variation in stiffness at rest

  14 days (0, 7 and 14 days)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Other: Fisiocrem

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

topical cream with same composition as Intervention but without active ingredients

Placebo

Fisiocrem OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uriach Consumer Healthcare: lead
• Quironsalud: collaborator

Study Sites (1)

QuironSalud Hosiptal

Barcelona, 08023, Spain

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Arthralgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases

Study Officials

• Silvia Ramon, MD, PhD

  Hospital QuiroSalud Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients were randomly assigned, using the Excel (Microsoft) RAND function, into 2 groups: treatment group and placebo group, a topical cream with similar characteristics and aspect, without active ingredients. Allocation was concealed from the recruiter and participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blinded and placebo-controlled clinical trial

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)