Efficacy of an Early Intervention Programme Using Therapeutic Exercise in Patients With Plantar Fasciopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The aim of this project is to evaluate the efficacy of a therapeutic exercise programme in patients with plantar fasciitis applied early and aimed at strengthening the hip and foot musculature.
详细描述
All patients will be informed about the study to be carried out and will give their prior informed consent. The programme has a first part of teaching directed to patients by physiotherapists, and a second part of application at home, with a duration of 12 weeks. An experimental study will be designed with random assignment of patients with similar characteristics to two groups. The non-experimental group will receive their usual treatment (medication and recommnendations as stretching) and the experimental group will follow their usual treatment and also participate in the therapeutic programe.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with referred pain in the medial plantar area of the heel, accentuated with initial steps after a period of inactivity but also worsening after prolonged body weight bearing, of at least 3 months evolution prior to inclusion in the study.
- •Reproduction of the pain referred by the patient with palpation at the proximal insertion of the plantar fascia.
排除标准
- •Pregnancy.
- •Injection of corticoids in the area in the 6 months prior to recruitment.
- •Previous illnesses that may alter gait (central or peripheral neurological pathology, degenerative and inflammatory arthropathies, systemic illnesses).
- •Existence of concomitant foot pathology (metatarsalgia, stress fractures, neuropathies due to entrapment, tendinitis, history of foot/ankle surgery, etc.).
- •People who do not have the capacity to understand and follow an exercise programme.
研究组 & 干预措施
Experimental group
People with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician and will also participate in the therapeutic exercise programme.
干预措施: Muscle strengthening (Other)
Non-experimental group
Individuals with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician
干预措施: Standard treatment (oral analgesic/anti-inflammatory drug) (Drug)
结局指标
主要结局
Pain intensity
时间窗: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
For its estimation a numerical pain rating scale will be used, where 0 represents no pain (at all) and 10, the worst pain imaginable. Using this instrument the patient should rate the intensity of pain at the start of walking in the morning (the first step), the worst time of the day and the average level of pain the participant has experienced in the last week. This is an easy to complete, quick and simple scale. A 2-point change on this scale is a clinically important difference in people with chronic pain.
Disability
时间窗: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
To be estimated using the Spanish version of the foot function index. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability and activity limitation.
General health and health-related quality of life:
时间窗: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
Is a generic instrument for measuring health-related quality of life. It has 5 health dimensions: mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression. Each of these has three levels of severity
Overall perception of clinical change
时间窗: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
The overall rating of change will be obtained using an 11-point scale. It measures the overall perceived change in the condition of their heel pain from the time they started the study to the present as "worse", "no change" or "better".
Physical activity
时间窗: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
t will be measured through the International Physical Activity Questionnaire (IPAQ). This questionnaire consists of 7 items. The aim of this instrument is to record the degree of physical activity, sitting hours and walking time of the subjects who complete it.
次要结局
未报告次要终点
研究者
Javier Marco Lledó
Universidad Miguel Hernández
Universidad Miguel Hernandez de Elche