Analysis of the Efficacy in the Lomg Term (Six Months Follow up) of the Combination of Radiofrecuency and Therapeutic Exercise Versus Therapeutic Exercise Alone in the Treatment of Patellofemoral Pain Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- The perception of pain through the Visual Analogue Scale (EVA).
研究概览
简要总结
The present study aims to promote research in the field of Physiotherapy, focusing on a health problem of maximum relevance, such as patellofemoral pain syndrome.
Although these treatments seem to be based on theoretical reasoning, the evidence for the efficacy of these interventions is not well established. Therefore, we select from among all the therapeutic tools available in physiotherapy, a procedure of therapeutic physical exercise.
Main objectives:
To know the efficacy of a therapeutic physical exercise protocol in the reduction of pain and the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS).
Secondary objectives:
- Quantify the reduction of pain in the anterior aspect of the knee in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
- To evaluate the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
Study hypothesis:
The treatment of patellofemoral pain syndrome (PFPS) with a therapeutic physical exercise protocol produces statistically significant changes in the reduction of pain and functional disability and the normalization of the anthropometric values of the joint balance of the knee
详细描述
At first, a meeting will be held with the patients under study where they will be informed and any doubts that may arise in relation to the investigation will be resolved. In addition, the correct adaptation of these to the inclusion and exclusion criteria of our study will be verified. Subsequently, they will be given individually the informed consent prepared expressly for the present study, the doubts arising with respect to this one will be resolved and their signature will proceed. At this time, and individually again, we will proceed to the development of the Clinical History of Physiotherapy where only the information necessary for our study will be collected.
To emphasize in this point that the participants will grant their consent for the treatment of the data obtained for scientific purposes, according to the legal norms.
Next, the patients will be randomly assigned to two groups: control group and experimental group. The randomization of the sample was done through the EPIDAR software in version 3.1 between the Experimental Group and the Control Group Subsequently, the evaluations and measurements of the study variables will be carried out by the research team.
CONTROL GROUP: You will be provided exclusively therapeutic exercises protocol to develop supervised by Physical Therapist that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate.
EXPERIMENTAL GROUP: After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar capacitive diathermy with radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with a therapeutic exercise program supervised by a Physiotherapist.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any contraindication for the use of MDR.
- •Present cognitive alterations.
- •Have undergone conservative or surgical treatment of the knee in less than 6 months.
- •Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.
结局指标
主要结局
The perception of pain through the Visual Analogue Scale (EVA).
时间窗: Time point 3: six months later the initial evaluation.
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain.
Kujala Score.
时间窗: Time point 3: six months later the initial evaluation.
The functional disability, quantified by means of the tests: Kujala Score.
次要结局
- Active and Pasive Knee's Range of Movement(Time point 3: six months later the initial evaluation.)
研究者
Manuel Albornoz Cabello
Clinical Professor
University of Seville