Analgesic Effect of a Biophotonic Foot Massage Cream
ConditionMusculoskeletal Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Seville
About this trial
This study aims to evaluate the effectiveness of a biophotonic cosmetic massage cream in reducing musculoskeletal foot pain in adults. Participants with pain in one or both feet attending the Podiatry Clinical Area of the University of Seville will be randomly assigned to receive either the investigational cream or a placebo cream with similar characteristics. The assigned product will be applied topically to the painful area twice daily for 10 consecutive days. Pain intensity, pressure pain threshold, foot function, and health-related quality of life will be assessed during the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Patients attending the Podiatry Clinical Area of the University of Seville.
Presence of musculoskeletal pain in one or both feet at the initial assessment.
Ability to understand the study information and provide written informed consent.
Disqualifiers
Foot pain of non-musculoskeletal origin, or pain mainly attributable to infectious, vascular, tumoral, severe neurological, or decompensated systemic diseases.
Wounds, ulcers, burns, dermatitis, skin infections, or any active skin disorder at the application site.
Known allergy, hypersensitivity, or previous adverse reaction to any component of the investigational cream or placebo.
Concomitant use of analgesic, anti-inflammatory, or topical treatments on the foot that may interfere with efficacy assessment, unless a washout period is established.
Trial design
Design model
Parallel
Treatments tested in this trial
Biophotonic cosmetic massage cream
Other interventionTopical self-application of the investigational cosmetic massage cream to the painful area of the foot, twice daily for 10 consecutive days, according to the instructions provided by the research team.
Placebo
Other interventionTopical self-application of the placebo cream to the painful area of the foot, twice daily for 10 consecutive days, according to the instructions provided by the research team.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Biophotonic cosmetic massage creamExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain intensity measured with the Numeric Pain Rating Scale (NPRS-11)
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS-11), which minimum value is 0 (that means no pain, the best result) and maximum value is 10 (that means the worst pain the participant could withstand). The primary endpoint will be the change in pain score from baseline to the end of the 10-day intervention period.
Time frame
Baseline to Day 10Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: