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Completed

NCT Number: NCT07388199

Foot Core Intervention for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Foot Core Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat de València

Valencia, 46010, Spain

About this 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foot Core

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Universidad de León

Registry information

Official study title

Effects of a Foot Core Training Program on Foot Pain, Function, and Pressure Pain Sensitivity in Patients With Fibromyalgia: A Quasi-Experimental Study.

Acronym: FOOTCORE-FM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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