Foot Core Intervention for Fibromyalgia (FOOTCORE-FM)

University of Valencia

Status: Completed

Conditions: Fibromyalgia; Foot Core

Treatments: Other: Foot Core

Study type: Interventional

Funder types: Other

Identifiers

NCT07388199

FOOTFIBRO_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Group Footcore

Experimental group

Description:

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.

Treatment:

Other: Foot Core