NCT07501273

Analgesic Effect of a Biophotonic Foot Massage Cream

Analgesic Effect of a Biophotonic Foot Massage Cream: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Foot pain is a common and clinically relevant problem in adults, and musculoskeletal foot pain is frequently managed with oral and topical pharmacological treatments. However, conventional analgesic and anti-inflammatory therapies may be associated with adverse effects, which supports the investigation of potentially safer conservative alternatives. This study is designed as a randomized, placebo-controlled, parallel-group clinical trial to assess whether a biophotonic cosmetic massage cream can significantly reduce musculoskeletal foot pain in adults. Eligible participants will be adults with musculoskeletal pain in one or both feet who attend the Podiatry Clinical Area of the University of Seville. Participants will be recruited consecutively in the context of routine clinical care and will be randomly assigned in a 1:1 ratio to either an experimental group receiving the biophotonic cosmetic massage cream or a control group receiving a placebo with similar characteristics. The intervention consists of topical self-application of the assigned product to the painful area of the foot twice daily for 10 consecutive days, following instructions provided by the research team. The primary outcome will be pain intensity measured using the Numeric Pain Rating Scale (NPRS-11). Secondary outcomes will include pressure pain threshold measured with a Wagner FPK 10 pressure algometer, foot pain and function assessed with the Foot Function Index, and health-related quality of life assessed with the SF-12 questionnaire. The planned sample size is 170 participants, corresponding to 85 per group, allowing for an anticipated 20% loss to follow-up. Statistical analyses will compare changes between groups and over time, with a significance level of 0.05 and analysis preferably following the intention-to-treat principle.

Conditions

• Musculoskeletal Pain

Interventions

Type	Name	Description
OTHER	Biophotonic cosmetic massage cream	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.
OTHER	Placebo	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.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-03-30
• Last updated: 2026-04-02