Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy: A Randomized Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Pain Level
研究概览
简要总结
This clinical study aims to evaluate the effectiveness of infiltrations in the treatment of plantar fasciopathy, a painful condition that affects the sole of the foot and is common in active people. Plantar fasciopathy is caused by inflammation or damage to the plantar fascia, the tissue that connects the heel to the toes. Participants in this study will be randomly assigned to receive one of two treatments: corticosteroid infiltrations or conservative treatment without infiltrations. Infiltrations will be guided by ultrasound to ensure accuracy. The study will evaluate pain reduction and improvement in foot function over a six-month period. The objective of the study is to determine if infiltrations provide a significant improvement compared to other non-invasive treatments. The results will help doctors and patients make informed decisions about the best treatment options for plantar fasciopathy.
详细描述
This clinical study, titled "Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy", will be carried out at the University of Seville and its main objective is to evaluate the impact of corticosteroid infiltrations on pain reduction and functional improvement in patients diagnosed with plantar fasciopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
In this study, a double-blind design is implemented to ensure data integrity and reduce bias. The following roles are masked:
Participants: Participants are not informed to which treatment group they have been assigned (corticosteroid infiltrations or conservative treatment).
Investigators: Investigators evaluating clinical outcomes, including pain measurement and foot function, are blinded to the treatment group assignment of participants.
Healthcare Providers: The professionals administering the infiltrations are masked regarding treatment assignment, as a third party, not involved in the study, will be responsible for performing the infiltrations.
Data Monitors: Data monitors monitoring the safety and integrity of the study are also blinded to treatment assignments until final analysis of the results is completed.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Participants aged 18 to 50 years. Diagnosis: Confirmed diagnosis of plantar fasciopathy based on clinical evaluation and imaging (if applicable).
- •Duration of Symptoms: Symptoms persisting for at least 6 weeks prior to enrollment.
- •Pain Level: Reported pain level of at least 4 on the Visual Analog Scale (VAS) at baseline.
- •Ability to Comply: Participants must be able to follow study protocols and attend follow-up appointments.
- •Informed Consent: Participants must provide written informed consent to participate in the study.
排除标准
- •Other Foot Pathologies: Presence of other significant foot conditions (e.g., fractures, arthritis, tarsal tunnel syndrome) that could interfere with the study results.
- •Pregnancy or Breastfeeding: Pregnant or breastfeeding individuals will be excluded from the study.
- •Neurological Disorders: History of significant neurological disorders affecting lower limb function.
- •Systemic Conditions: Patients with systemic conditions (e.g., diabetes, autoimmune diseases) that could affect healing or response to treatment.
- •Allergy to Corticosteroids: Known allergy or adverse reaction to corticosteroids or local anesthetics.
- •Psychiatric Disorders: Individuals with severe psychiatric disorders that may impair their ability to provide informed consent or adhere to the study protocol.
研究组 & 干预措施
Corticoesteroid Infiltrations
In this group, participants will receive infiltrations directly into the affected plantar fascia. This intervention aims to reduce the inflammation and pain associated with plantar fasciopathy.
干预措施: Infiltration (Drug)
Conservative treatment
Participants in this group will receive conservative treatment that does not include infiltrations. This approach is based on non-invasive methods that are commonly used to manage plantar fasciopathy.
干预措施: Conservative treatment (Other)
结局指标
主要结局
Change in Pain Level
时间窗: Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.
Pain level will be assessed using the Visual Analogue Scale 0 to 10 points (VAS), where participants will mark their pain level on a 10 cm line, from \"no pain\" (0) to \"unbearable pain\" (10).
次要结局
- Functional Improvement(Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.)
研究者
ANA MARIA RAYO PEREZ
Principal Investigator
University of Seville