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| Name | Class |
|---|---|
| Universidad de León | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roi Painceira Villar, Phd | Universidad de León | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat de València | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33024295 | Background | 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. | |
| 33918736 | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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.
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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.
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| 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. | 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. | Baseline (Week 0) and Post-intervention (Week 8) |
| 35647877 | 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. |
| 21905019 | 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. |
| 36728497 | 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. |
| 23001756 | 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. |
| 9770933 | 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. |
| D009422 |
| Nervous System Diseases |