Effects of a Foot Core Training Program on Foot Pain, Function, and Pressure Pain Sensitivity in Patients With Fibromyalgia: A Quasi-Experimental Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Foot Pain (FHSQ Foot Pain Domain)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Foot Core (Other)
结局指标
主要结局
Foot Pain (FHSQ Foot Pain Domain)
时间窗: 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.
次要结局
- 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))
研究者
CARMEN GARCÍA GOMARIZ
principal investigator
University of Valencia