Comparison of Responsiveness of Different Pain and Disability Measurements in Patients With Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Heel Tenderness Index
研究概览
简要总结
The aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the Physical Medicine and Rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave therapy (ESWT) treatment.
详细描述
The study was designed as prospective observational research. Between December 2019 and May 2020, 90 patients who were admitted to the Physical Therapy and Rehabilitation outpatient clinic for ESWT were planned to be included in the study. Pre-treatment pain values of patients with 3 different examination methods (visual analog scale, numerical pain scale and heel sensitivity index), 3 different disability index Foot function index, Foot and Ankle Outcome Score, The American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score will be used.
These methods will be evaluated before and after ESWT treatment and the responsiveness and minimal clinically important difference of the questionnaires will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older
- •Patients with chronic heel complaints for more than 1 month
- •Patients queued for ESWT
排除标准
- •Patients under the age of 18
- •Patients who do not want to participate in the study voluntarily
- •Patient undergone physical therapy for the same heel in the last 6 months
- •Patients treated for heel pain
- •Rheumatologic diseases that cause heel pain (ankylosing spondylitis, Behçet's disease)
- •Neurological diseases (such as diabetic polyneuropathy, postpolio syndrome)
- •Patients with malignancy
- •Illiterate patients with speech pathology
结局指标
主要结局
Heel Tenderness Index
时间窗: 15 days
0-3 points according to the palpation of the heel. "0" means no pain, "1" = painful, "2" = painful and winces and "3"= painful,winces and withdraws.
Numeric Rating Scale
时间窗: 15 days
11 points scale as 0 means no pain and 10 points means worst pain ever.
Foot Function Index
时间窗: 15 days
A Foot Function Index was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Higher scores show higher disability and worst outcomes.
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
时间窗: 15 days
The questionnaire includes nine items that can be divided into three subscales (pain, function and alignment). Each of the nine items is scored, accumulating to a total score ranging from 0 points (indicating severe pain and impairment) to 100 points (no symptoms or impairment).
Visual Analog Scale
时间窗: 15 days
Pain severity assessment on a line from 0 to 10 points. As "0" means no pain and "10" points is the worst pain ever.
Foot and Ankle Outcome Score
时间窗: 15 days
The Foot and Ankle Outcome Score is an adaption of Knee injury and Osteoarthritis Outcome Score that assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
次要结局
未报告次要终点
研究者
Mehmet Akif GÜLER
Principal Investigator
Gaziosmanpasa Research and Education Hospital