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临床试验/NCT05811637
NCT05811637已完成不适用

Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

Istanbul University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Functional assessment

研究概览

简要总结

This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term.

详细描述

Patellofemoral pain is a common condition characterized by pain in anterior knee, around the kneecap. It is known that exercise is beneficial in rehabilitation in general. Exercise programs applied to patients with PFP should include hip and knee-targeted combined exercises. Nowadays, Pilates is used as an effective rehabilitation tool for individuals with musculoskeletal problems, especially in reducing pain and improving function. Therefore, we believe that Pilates exercises can be effective in PFP Considering that PFP is a chronic condition and exercise therapy is one of the main strategies in the treatment. Pilates may be preferred as one of the alternative treatment method.

This randomized controlled study was designed to compare the effects of two different treatment protocols, Group-I (Supervised Rehabilitation) and Group-II (Pilates Exercises). Patients who applied to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Sports Medicine outpatient clinic and were diagnosed with PFP by a specialist physician based on the patient histories, physical examinations, and diagnostic imaging. The estimated desired sample size was at least 14 participants per group. We anticipated a dropout rate of 20%. Therefore, 34 participants were required for each group (Supervised Rehabilitation n=17, Pilates Exercises n=17) of both sexes, ages ranging from 18-45 years. A computer generated randomization list was used to divide the patients into two groups (https://www.randomizer.org/). An 'Informed Consent Form' was obtained from patients by explaining the purpose of the study, the duration of the study, the treatments to be applied, and possible side effects.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having characteristic signs of PFP (retropatellar or peripatellar pain)
  • Presence of at least 3 points of retropatellar or peripatellar pain on the Numbered Pain Rating Scale (NPRS) with squatting, climbing stairs, prolonged sitting, or functional activity that burdens the PFP
  • Presence of any of the criteria such as tenderness, small effusion in the patellar facet palpation

排除标准

  • Patellofemoral dislocation, subluxation, intra-articular knee pathology
  • Previous lower extremity surgery, and knee-related trauma
  • A history of hip pathology or neurological disorders
  • Knee trauma in the last 1 month

结局指标

主要结局

Functional assessment

时间窗: 6 weeks

Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.

Pain assessment

时间窗: 6 weeks

The numerical NPRS is used to measure and monitor the severity of pain. The patients will be asked to rate the severity of the current pain level between 0 and 10 (0 being "no pain" and 10 being the "worst imaginable pain").

次要结局

  • Muscle flexibility assessment(6 weeks)
  • Muscle strength assessment(6 weeks)
  • Quality of life assessment(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Celik

Prof.

Istanbul University

研究点 (1)

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