Randomized Pilot Feasibility Trial on the Clinical Effects of Custom and Prefabricated Foot Orthoses in Patients With Painful Hallux Valgus.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This randomized pilot feasibility trial will evaluate the feasibility of conducting a full-scale randomized controlled trial comparing custom-made, prefabricated, and sham foot orthoses in people with painful hallux valgus. All participants will also receive a standardized program of foot exercises and education. Thirty-six participants will be randomized to one of the three intervention groups and assessed at baseline, 6 weeks, and 12 weeks. The primary outcomes will assess the feasibility of recruitment, retention, treatment adherence, intervention credibility and expectancy, and use of cointerventions. Secondary outcomes will assess foot pain and function, perceived clinical improvement, and health-related quality of life. The findings will inform the design and conduct of a future full-scale randomized controlled trial.
详细描述
Background: Hallux valgus is a common foot deformity that causes significant pain, limits function and negatively impacts health-related quality of life. Foot orthoses (FOs), whether custom-made or prefabricated, are often prescribed to alleviate symptoms and improve function. However, their clinical effectiveness in individuals with painful hallux valgus remains unclear. The primary objective of this trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial comparing three multifaceted interventions combining foot exercises and education with custom FOs, prefabricated FOs, or sham FOs in patients with painful hallux valgus.
Methods/design: This participant-blinded, superiority, randomized pilot feasibility trial with three parallel groups will be conducted in Trois-Rivières, Canada. Thirty-six participants with painful hallux valgus will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and through social media advertisements. Participants will be randomized to receive custom, prefabricated, or sham FOs. All groups will also receive a program of foot exercises and education about their condition. Participants will be evaluated at baseline and at 6- and 12-weeks time points. The primary feasibility outcomes will include recruitment rate, conversion rate, retention rate, adherence to treatment, intervention credibility and expectancy, and use of cointerventions. Secondary efficacy outcomes will include foot pain and limitations (Foot Function Index; average and maximal daily pain), self-assessed clinical progress (Global Rating of Change), and health-related quality of life (EQ-5D-5L).
Discussion: This trial will determine the feasibility of conducting a full-scale randomized controlled trial comparing the efficacy of custom and prefabricated FOs in reducing pain and improving function in patients with a painful hallux valgus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 74 years;
- •Have unilateral or bilateral hallux valgus (Manchester scale ≥ 2) with pain for at least 3 months (average pain score ≥ 3 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities. If participants have bilateral hallux valgus, the most painful foot will be used for data collection. Participants with pain secondary to friction between the first metatarsophalangeal joint and the shoe will be excluded unless the intra-articular or plantar pain is more significant;
- •Can walk without assistive devices (e.g., cane, walker);
- •Are willing to wear shoes that accommodate their foot orthoses daily;
- •Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.
排除标准
- •Inflammatory conditions (e.g., arthritis, gout), neurological diseases and other sources of mechanical foot pain;
- •History of orthopedic foot surgery;
- •Prior use of custom or prefabricated foot orthoses in the past 12 weeks;
- •Cognitive impairment;
- •Currently pregnant or breastfeeding;
- •Participation in foot exercises within the past 12 weeks;
- •Less than 10 degrees range of motion at the first metatarsophalangeal joint.
结局指标
主要结局
Recruitment rate
时间窗: Baseline
The number of participants recruited per month.
Conversion rate
时间窗: Baseline
The proportion of individuals providing consent to participate from those who met the selection criteria.
Foot orthoses average wear time
时间窗: From baseline to end of treatment at 12 weeks
Average number of hours the FOs are worn per day.
Adherence to the exercise program
时间窗: From allocation to end of treatment at 12 weeks
The average number of days the exercise program was performed weekly.
Adverse events
时间窗: From allocation to end of treatment at 12 weeks
Participants will be asked to report adverse events they encounter, body location and severity. Adverse events will be classified as unrelated, probably related or definitely related to their participation in the trial.
Credibility and Expectancy of the Intervention questionnaire
时间窗: Baseline
The Credibility and Expectancy of the Intervention questionnaire (CEQ) is a widely used, valid, and reliable self-administered questionnaire designed to assess participants' perceptions of the credibility of an intervention and their expectations regarding its potential effectiveness (23). It consists of 6 items divided into two domains: treatment credibility (3 items) and expectancy of improvement (3 items). The credibility subscale evaluates how logical and convincing participants perceive the intervention to be, while the expectancy subscale assesses the degree to which participants believe the intervention will improve their condition. Scores from both subscales will be analyzed to evaluate participants' perceptions of the intervention.
次要结局
- Foot Function Index(At baseline and after 6 and 12 weeks of treatment)
- Mean and maximal pain during walking during the past week(At baseline and after 6 and 12 weeks of treatment)
- Global rating of change(After 6 and 12 weeks of treatment)
- Health-related quality of life(At baseline and after 6 and 12 weeks of treatment)