Foot Core Intervention for Fibromyalgia

NCT07388199 | Completed

• 1 other identifier: FOOTFIBRO_01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fibromyalgia; Foot Core

Keywords

Foot pain; Foot function; Pressure pain sensitivity; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Pressure Pain Sensitivity (Pressure Pain Thresholds by Algometry)

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

• Vigor and General Health (FHSQ Domains)

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

• Physical Activity and Social Capacity (FHSQ Domains)

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

Study Arms (1)

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.

Other: Foot Core

Interventions

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.

Group Footcore

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Universidad de León: collaborator

Study Sites (1)

Universitat de València

Valencia, 46010, Spain

Location

Related Publications (7)

• 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.

  PMID: 33024295 BACKGROUND

• Siracusa 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.

  PMID: 33918736 BACKGROUND

• Hoegh 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.

  PMID: 35647877 BACKGROUND

• Smith 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.

  PMID: 21905019 BACKGROUND

• Beiner 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.

  PMID: 36728497 BACKGROUND

• Sun 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.

  PMID: 23001756 BACKGROUND

• Bennett 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.

  PMID: 9770933 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Roi Painceira Villar, Phd

  Universidad de León

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study uses partial masking. Participants were not blinded, as they were aware of their participation in an exercise-based intervention and the nature of the foot core training program. However, the outcome assessor was blinded to the study objectives and to the timing of the evaluations (baseline vs. post-intervention) to minimize assessment bias. The assessor responsible for collecting FHSQ scores and pressure pain threshold measurements did not have access to participant allocation information, intervention details, or previous results. This single-blind approach ensures that outcome measurements are performed objectively, reducing potential expectancy or observational bias typically associated with non-blinded participants in exercise studies.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 22, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)