Foot Core Intervention for Fibromyalgia (FOOTCORE-FM)

January 30, 2026 updated by: CARMEN GARCÍA GOMARIZ, University of Valencia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Universitat de València

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Footcore
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.
Other: Foot Core
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0) and Post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Sensitivity (Pressure Pain Thresholds by Algometry)
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)

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.
Baseline (Week 0) and Post-intervention (Week 8)
Vigor and General Health (FHSQ Domains)
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)

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.
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)

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.
Baseline (Week 0) and Post-intervention (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Universidad de León

Investigators

  • Principal Investigator: Roi Painceira Villar, Phd, Universidad de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 22, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOOTFIBRO_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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