Analgesic Effect of a Biophotonic Foot Massage Cream

NCT07501273 | Not Yet Recruiting

• 1 other identifier: BEIMAN_PIE
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Musculoskeletal Pain

Keywords

Foot pain; Musculoskeletal pain; Biophotonic cream; Topical treatment; Placebo; Randomized clinical trial; Podiatry

Outcome Measures

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.

  Baseline to Day 10

Study Arms (2)

Biophotonic cosmetic massage cream

EXPERIMENTAL

Biophotonic cosmetic massage cream

Other: Biophotonic cosmetic massage cream

Placebo

PLACEBO COMPARATOR

Topical 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.

Other: Placebo

Interventions

Placebo OTHER

Topical 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.

Placebo

Biophotonic cosmetic massage cream OTHER

Topical 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.

Biophotonic cosmetic massage cream

Eligibility Criteria

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

You may qualify if:

• 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.
• Ability to follow study instructions and complete study assessments.
• Intact skin at the application site.

You may not qualify if:

• 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.
• Recent infiltrations, surgery, or invasive treatment on the foot or ankle that may alter pain evolution during the study.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pedro Vicente Munuera-Martínez, Ph.D

CONTACT

+34696437996; pmunuera@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share