FibromyalgiaFOOTCORE-FMNCT07388199
Foot Core Intervention for Fibromyalgia
A study testing Foot Core in people with Fibromyalgia and Foot Core, run by University of Valencia at 1 site in Spain.
Trial summary
This quasi-experimental study was designed to evaluate the effects of an eight-week foot core training program on foot pain, foot function, and pressure pain sensitivity in individuals with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Foot Core
- What is being tested?
- Foot Core
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Medical diagnosis of fibromyalgia according to the current American College of - Rheumatology (ACR) criteria and the AAPT criteria.
- Ability to understand instructions and complete all assessment procedures.
- Capacity to perform the exercise program without severe motor impairments that would limit participation.
- Voluntary agreement to participate and signed informed consent.
Who cannot join
- Severe comorbidities (e.g., cardiovascular, neurological, or systemic conditions) that could interfere with participation.
- Relevant pre-existing podiatric pathologies that may alter foot mechanics or confound outcomes.
- Pregnancy.
- Severe psychiatric disorders that could interfere with adherence or accurate outcome assessment.
- Inability to attend sessions or comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Foot Core Training Program on Foot Pain, Function, and Pressure Pain Sensitivity in Patients With Fibromyalgia: A Quasi-Experimental Study.
This quasi-experimental study was designed to evaluate the effects of an eight-week foot core training program on foot pain, foot function, and pressure pain sensitivity in individuals with fibromyalgia. Participants were recruited among individuals diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) and the American Pain Society-American Academy of Pain Medicine (AAPT) criteria.
The intervention consisted of a structured foot core training program focused on strengthening the intrinsic foot musculature. Assessments were conducted before and after the intervention period. Outcome measures included foot pain and foot function assessed using the Foot Health Status Questionnaire (FHSQ), as well as pressure pain thresholds measured using mechanical algometry at six predefined rearfoot anatomical points.
Read the detailed description
This quasi-experimental study was designed to evaluate the effects of an eight-week foot core training program on foot pain, foot function, and pressure pain sensitivity in individuals with fibromyalgia. Participants were recruited from individuals diagnosed with fibromyalgia in accordance with the criteria established by the American College of Rheumatology (ACR) and the American Pain Society-American Academy of Pain Medicine (AAPT).
The intervention consisted of a structured foot core training program aimed at strengthening the intrinsic musculature of the foot and was implemented over an eight-week period. The program was designed to be delivered in a systematic and progressive manner.
Assessments were performed prior to the initiation of the intervention and at the end of the eight-week training period. Outcome measures included foot pain and foot function, assessed using the Foot Health Status Questionnaire (FHSQ). Pressure pain sensitivity was evaluated using mechanical algometry, with pressure pain thresholds recorded at six predefined anatomical points of the rearfoot.
All measurements were conducted following standardized procedures and by trained personnel. The data collected were intended to examine changes in foot-related outcomes and pressure pain sensitivity following completion of the intervention.
- Conditions
- Fibromyalgia, Foot Core
- Being tested
- Foot Core
- Keywords
- Foot pain, Foot function, Pressure pain sensitivity, Quality of life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot CoreOther
Eight-week supervised foot core training (2×/week, 45 min) including mobility, intrinsic foot muscle strengthening, and progressive balance tasks. Exercises progressed from basic activation to standing and single-leg control. Load was individualized to prevent symptom exacerbation and ensure safe participation.
| Study group | Role | What they receive |
|---|---|---|
| Group Footcore | Experimental | The experimental group consisted of adults with medically diagnosed fibromyalgia who completed an eight-week supervised foot core training program (2 sessions/week, 45 minutes), including intrinsic foot strengthening and progressive balance tasks. All participants received the same intervention, with individualized load adjustment to ensure safety and prevent symptom exacerbation. Receives: Other: Foot Core |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Pain (FHSQ Foot Pain Domain)
Change in foot pain as measured by the Foot Health Status Questionnaire (Foot Pain domain).
The Foot Health Status Questionnaire (FHSQ) is a validated, foot-specific patient-reported outcome measure. Scores range from 0 to 100, where higher scores indicate better foot health and less pain, and lower scores indicate worse foot pain. A score of 0 represents the worst possible foot pain, and a score of 100 represents no foot pain / best possible foot health.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Secondary outcomes (3)
Pressure Pain Sensitivity (Pressure Pain Thresholds by Algometry)
Change in pressure pain thresholds measured with a mechanical algometer (Fischer FDK/FDN).
Pressure pain thresholds were assessed using a mechanical algometer (Fischer FDK/FDN). Pressure was applied gradually at a rate of 1 kg/s at six anatomical sites of the rearfoot (right and left sinus tarsi, medial malleolus, and lateral malleolus). Measurements were recorded in kilograms per square centimeter (kg/cm²). The measurement range was 0 to 11 kg/cm², where higher values indicate higher pressure pain thresholds and reduced mechanosensitivity, and lower values indicate greater pain sensitivity.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Vigor and General Health (FHSQ Domains)
Change in vitality and general health as measured by the Foot Health Status Questionnaire (FHSQ).
Vitality and general health were assessed using the corresponding domains of the Foot Health Status Questionnaire (FHSQ), a validated foot-specific patient-reported outcome measure. Each domain is scored on a scale ranging from 0 to 100, where higher scores indicate better vitality and better perceived general health, and lower scores indicate worse vitality and poorer perceived general health. A score of 0 represents the worst possible status, and a score of 100 represents the best possible status for each domain.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Physical Activity and Social Capacity (FHSQ Domains)
Change in physical activity levels and social participation as measured by the Foot Health Status Questionnaire (FHSQ).
Physical activity and social participation related to foot health were assessed using the corresponding domains of the Foot Health Status Questionnaire (FHSQ), a validated foot-specific patient-reported outcome measure. Each domain is scored on a scale ranging from 0 to 100, where higher scores indicate better physical activity levels and greater social participation, and lower scores indicate worse functional capacity. A score of 0 represents the worst possible status, and a score of 100 represents the best possible status for each domain.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2025
- Primary completion15 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-group, pre-post quasi-experimental design, in which all participants receive the same intervention and outcomes are measured before and after the program. There is no control group or randomization.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de León
- Responsible party
- Principal investigator, CARMEN GARCÍA GOMARIZ, University of Valencia
- Investigators
- Roi Painceira Villar, Phd, Principal investigator, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388199
- Sponsor's protocol ID
- FOOTFIBRO_01
- Acronym
- FOOTCORE-FM
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
PubMed 33024295Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.
PubMed 33918736Hoegh M. Pain Science in Practice (Part 3): Peripheral Sensitization. J Orthop Sports Phys Ther. 2022 Jun;52(6):303-306. doi: 10.2519/jospt.2022.11202.
PubMed 35647877Smith SB, Maixner DW, Fillingim RB, Slade G, Gracely RH, Ambrose K, Zaykin DV, Hyde C, John S, Tan K, Maixner W, Diatchenko L. Large candidate gene association study reveals genetic risk factors and therapeutic targets for fibromyalgia. Arthritis Rheum. 2012 Feb;64(2):584-93. doi: 10.1002/art.33338.
PubMed 21905019Beiner E, Lucas V, Reichert J, Buhai DV, Jesinghaus M, Vock S, Drusko A, Baumeister D, Eich W, Friederich HC, Tesarz J. Stress biomarkers in individuals with fibromyalgia syndrome: a systematic review with meta-analysis. Pain. 2023 Jul 1;164(7):1416-1427. doi: 10.1097/j.pain.0000000000002857. Epub 2023 Jan 5.
PubMed 36728497Sun N, Hartmann R, Lecher J, Stoldt M, Funke SA, Gremer L, Ludwig HH, Demuth HU, Kleinschmidt M, Willbold D. Structural analysis of the pyroglutamate-modified isoform of the Alzheimer's disease-related amyloid-beta using NMR spectroscopy. J Pept Sci. 2012 Nov;18(11):691-5. doi: 10.1002/psc.2456. Epub 2012 Sep 24.
PubMed 23001756Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
PubMed 9770933
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Foot Core Training Program on Foot Pain, Function, and Pressure Pain Sensitivity in Patients With Fibromyalgia: A Quasi-Experimental Study.
- ClinicalTrials.gov ID
- NCT07388199
- Acronym / sponsor ID
- FOOTCORE-FM / FOOTFIBRO_01
- Conditions
- Fibromyalgia, Foot Core
- Keywords
- Foot pain, Foot function, Pressure pain sensitivity, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Universidad de León
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 4 Feb 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 quasi-experimental study was designed to evaluate the effects of an eight-week foot core training program on foot pain, foot function, and pressure pain sensitivity in individuals with fibromyalgia. Participants were recruited among individuals diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) and the American Pain Society-American Academy of Pain Medicine (AAPT) criteria.
The intervention consisted of a structured foot core training program focused on strengthening the intrinsic foot musculature. Assessments were conducted before and after the intervention period. Outcome measures included foot pain and foot function assessed using the Foot Health Status Questionnaire (FHSQ), as well as pressure pain thresholds measured using mechanical algometry at six predefined rearfoot anatomical points.
Detailed description
This quasi-experimental study was designed to evaluate the effects of an eight-week foot core training program on foot pain, foot function, and pressure pain sensitivity in individuals with fibromyalgia. Participants were recruited from individuals diagnosed with fibromyalgia in accordance with the criteria established by the American College of Rheumatology (ACR) and the American Pain Society-American Academy of Pain Medicine (AAPT).
The intervention consisted of a structured foot core training program aimed at strengthening the intrinsic musculature of the foot and was implemented over an eight-week period. The program was designed to be delivered in a systematic and progressive manner.
Assessments were performed prior to the initiation of the intervention and at the end of the eight-week training period. Outcome measures included foot pain and foot function, assessed using the Foot Health Status Questionnaire (FHSQ). Pressure pain sensitivity was evaluated using mechanical algometry, with pressure pain thresholds recorded at six predefined anatomical points of the rearfoot.
All measurements were conducted following standardized procedures and by trained personnel. The data collected were intended to examine changes in foot-related outcomes and pressure pain sensitivity following completion of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-group, pre-post quasi-experimental design, in which all participants receive the same intervention and outcomes are measured before and after the program. There is no control group or randomization.
| Arm | Type | Receives |
|---|---|---|
| Group Footcore | Experimental | Other: Foot CoreThe experimental group consisted of adults with medically diagnosed fibromyalgia who completed an eight-week supervised foot core training program (2 sessions/week, 45 minutes), including intrinsic foot strengthening and progressive balance tasks. All participants received the same intervention, with individualized load adjustment to ensure safety and prevent symptom exacerbation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years.
- Medical diagnosis of fibromyalgia according to the current American College of - Rheumatology (ACR) criteria and the AAPT criteria.
- Ability to understand instructions and complete all assessment procedures.
- Capacity to perform the exercise program without severe motor impairments that would limit participation.
- Voluntary agreement to participate and signed informed consent.
Key exclusion criteria (5 listed)
- Severe comorbidities (e.g., cardiovascular, neurological, or systemic conditions) that could interfere with participation.
- Relevant pre-existing podiatric pathologies that may alter foot mechanics or confound outcomes.
- Pregnancy.
- Severe psychiatric disorders that could interfere with adherence or accurate outcome assessment.
- Inability to attend sessions or comply with study procedures.
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 |
|---|---|---|
| Foot CoreEight-week supervised foot core training (2×/week, 45 min) including mobility, intrinsic foot muscle strengthening, and progressive balance tasks. Exercises progressed from basic activation to standing and single-leg control. Load was individualized to prevent symptom exacerbation and ensure safe participation. | Other | Group Footcore |
Primary outcome
Foot Pain (FHSQ Foot Pain Domain)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Change in foot pain as measured by the Foot Health Status Questionnaire (Foot Pain domain). The Foot Health Status Questionnaire (FHSQ) is a validated, foot-specific patient-reported outcome measure. Scores range from 0 to 100, where higher scores indicate better foot health and less pain, and lower scores indicate worse foot pain. A score of 0 represents the worst possible foot pain, and a score of 100 represents no foot pain / best possible foot health.
3 secondary outcomes
Pressure Pain Sensitivity (Pressure Pain Thresholds by Algometry)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Vigor and General Health (FHSQ Domains)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Physical Activity and Social Capacity (FHSQ Domains)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 33024295Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
- Background: PubMed 33918736Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.
- Background: PubMed 35647877Hoegh M. Pain Science in Practice (Part 3): Peripheral Sensitization. J Orthop Sports Phys Ther. 2022 Jun;52(6):303-306. doi: 10.2519/jospt.2022.11202.
- Background: PubMed 21905019Smith SB, Maixner DW, Fillingim RB, Slade G, Gracely RH, Ambrose K, Zaykin DV, Hyde C, John S, Tan K, Maixner W, Diatchenko L. Large candidate gene association study reveals genetic risk factors and therapeutic targets for fibromyalgia. Arthritis Rheum. 2012 Feb;64(2):584-93. doi: 10.1002/art.33338.
- Background: PubMed 36728497Beiner E, Lucas V, Reichert J, Buhai DV, Jesinghaus M, Vock S, Drusko A, Baumeister D, Eich W, Friederich HC, Tesarz J. Stress biomarkers in individuals with fibromyalgia syndrome: a systematic review with meta-analysis. Pain. 2023 Jul 1;164(7):1416-1427. doi: 10.1097/j.pain.0000000000002857. Epub 2023 Jan 5.
- Background: PubMed 23001756Sun N, Hartmann R, Lecher J, Stoldt M, Funke SA, Gremer L, Ludwig HH, Demuth HU, Kleinschmidt M, Willbold D. Structural analysis of the pyroglutamate-modified isoform of the Alzheimer's disease-related amyloid-beta using NMR spectroscopy. J Pept Sci. 2012 Nov;18(11):691-5. doi: 10.1002/psc.2456. Epub 2012 Sep 24.
- Background: PubMed 9770933Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
- 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. This study is not recruiting at the moment.
Roi Painceira Villar, Phd principal investigator
Universidad de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Core in people with Fibromyalgia and Foot Core, run by University of Valencia at 1 site in Spain.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Pain (FHSQ Foot Pain Domain) (time frame: Baseline (Week 0) and Post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07388199, which also lists 7 linked publications.
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 4 Feb 2026.