Musculoskeletal PainNo acronymNCT07501273
Analgesic Effect of a Biophotonic Foot Massage Cream
A study testing Biophotonic cosmetic massage cream in people with Musculoskeletal Pain, run by University of Seville.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Biophotonic cosmetic massage cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Effect of a Biophotonic Foot Massage Cream: A Randomized Clinical 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.
Read the 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
- Being tested
- Biophotonic cosmetic massage cream, Placebo
- Keywords
- Foot pain, Musculoskeletal pain, Biophotonic cream, Topical treatment, Placebo, Randomized clinical trial, Podiatry
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biophotonic cosmetic massage creamOther
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Biophotonic cosmetic massage cream | Experimental | Biophotonic cosmetic massage cream Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro V. Munuera-Martínez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501273
- Sponsor's protocol ID
- BEIMAN_PIE
- Acronym
- No acronym
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of a Biophotonic Foot Massage Cream: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07501273
- Acronym / sponsor ID
- No acronym / BEIMAN_PIE
- Conditions
- Musculoskeletal Pain
- Keywords
- Foot pain, Musculoskeletal pain, Biophotonic cream, Topical treatment, Placebo, Randomized clinical trial, Podiatry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biophotonic cosmetic massage cream | Experimental | Other: Biophotonic cosmetic massage creamBiophotonic cosmetic massage cream |
| Placebo | Placebo comparator | Other: PlaceboTopical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biophotonic cosmetic massage creamTopical 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 | Biophotonic cosmetic massage cream |
| PlaceboTopical 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 |
Primary outcome
Change in pain intensity measured with the Numeric Pain Rating Scale (NPRS-11)
Time frame: Baseline to Day 10
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Biophotonic cosmetic massage cream in people with Musculoskeletal Pain, run by University of Seville.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Vicente Munuera-Martínez, Ph.D (+34696437996, pmunuera@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured with the Numeric Pain Rating Scale (NPRS-11) (time frame: Baseline to Day 10). 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 2 Apr 2026.