Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in the Foot Health Status Questionnaire (FHSQ)
研究概览
简要总结
Plantar fasciitis (PF) is one of the most common causes of heel pain in 40-60 year old people. Approximately 10% of the population is affected by the disorder and the PF prevalence is 3.6-7.0%. The risk factors include decreased ankle dorsiflexion, overweight (BMI> 27), pronated foot position, and prolonged work and activity-related weight bearing. The condition affects both active and less active people.
The typical symptoms are pain around the attachment of the foot's tendon mirror (fascia plantaris), especially the medial part. The pain is well defined and occurs during weight bearing activities or during the first steps after rest. The walking pattern is changed to relieve pain. Ultrasound scan is used to confirm the diagnosis (thickened tendon mirror> 4 mm). The condition is described as inflammatory, but the relationship between the initial inflammatory condition and the chronic tendon mirror overload injury (fasciopathy) is unknown and marked by degenerative changes.
Although the majority of people improve within 1-2 years, the long-term prognosis is unknown. People with symptoms lasting > 7 months have poor prognosis and should be offered other treatment. Non-surgical treatment is often first line of treatment followed by surgical treatment.
In this clinical trial investigators compare pain levels (FHSQ-DK) in people, who receive surgical treatment (radiofrequency microtenotomy, shoe inserts and patient education) and people who receive non-surgical treatment (strength training, shoe inserts and patient education) with a primary end-point at 6 months. The hypothesis is that surgical treatment is better than non-surgical treatment measured by FHSQ-DK (pain)
详细描述
To be completed later
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 (Investigator, Outcomes Assessor)
盲法说明
Blinding to treatment allocation of patients, physiotherapists (health care providers) will not be possible due to the nature of the interventions. However, independent data collectors will be responsible for baseline and follow-up assessments, while all self-reported outcome measures will be made available to the patients electronically, and responses entered into a database identified by identification numbers only. The data analyst will be unaware of the treatment allocation as data will be analyzed using recoded identification numbers. The recoding will be performed by an independent person.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VAS pain score > 30 within last 7 days
- •Plantar heel pain> 7 months
- •Palpation soreness fascia plantaris at heel
- •Plantar heel pain during first steps (First-step sign)
- •Read and understand Danish
排除标准
- •Systemic diseases or neuropathy
- •Previous heel surgery on same foot
- •Cortisone injections within past 3 months
- •Bilateral symptom onset within past 7 days
- •Signs of tarsal tunnel
- •Facia plantaris thickness of less than 4 mm
- •Performed message / head recovery / stretching within the past month
- •Any treatment for plantar pain within the past 3 months
- •Other reasons
结局指标
主要结局
Change in the Foot Health Status Questionnaire (FHSQ)
时间窗: Change from baseline at 6 months
Subdomain foot pain score range 0-100, low values represent worse conditions
次要结局
- The Foot Health Status Questionnaire (FHSQ)(Change from baseline at 6 months)
- Visual Analog Scale (VAS)(Change from baseline at 6 months)
- Global Percieved Effect (GPE)(1,3,6,12 months post-intervention)
- Physical Activity Questionnaire (IPAQ)(Change from baseline at 6 months)
研究者
Carsten Jensen
Associate professor
University of Southern Denmark