跳至主要内容
临床试验/NCT03515720
NCT03515720已完成不适用

Effectiveness of Neuroprolotherapy With Home Physical Therapy Against Isolated Physical Therapy for the Treatment of Patellar Chondromalacia

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月1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
50
试验地点
2
主要终点
WOMAC Osteoarthritis Index

研究概览

简要总结

Patellar chondromalacia is the degeneration of articular cartilage located on the posterior face of the patella and may suggest the onset of an osteoarthrosis. It predominates in sedentary people who overload the joint, as well as people with insufficiency in the extensor muscles of the knee. It is often seen between 30 and 40 years. Conservative management is the main treatment option and surgical intervention is considered as a last option in a small number of patients. A new treatment option is neuroprolotherapy where the approach is directed at the subcutaneous nerves as the source of pathology, which can lead to neurogenic inflammation and pain.

详细描述

Introduction

Patellar chondromalacia is the degeneration of articular cartilage located on the posterior face of the patella and may suggest the onset of an osteoarthrosis. It predominates in sedentary people who overload the joint, as well as people with insufficiency in the extensor muscles of the knee. It is often seen between 30 and 40 years. Conservative management is the main treatment option and surgical intervention is considered as a last option in a small number of patients. A new treatment option is neuroprolotherapy where the approach is directed at the subcutaneous nerves as the source of pathology, which can lead to neurogenic inflammation and pain.

Objective

To evaluate the efficacy of neuroprolotherapy combined with a home physical therapy program in patients with a diagnosis of patellar chondromalacia against a control group receiving only physical therapy at home.

Methodology: Randomized clinical trial. We studied patients from the Rehabilitation Service with clinical and radiographic diagnosis of patellar chondromalacia. Two groups were studied: the first group received treatment with neuroprolotherapy combined with home physical therapy and the second group was managed with physical therapy alone, measuring the results by the WOMAC test at baseline and at 6 weeks thereafter.

Statistic analysis: The statistical analysis will be carried out in two stages, descriptive and analytical. In the first, the variables are presented as raw numbers, proportions and means of central tendency and dispersion. The analytical stage between the groups will be done by means of the Chi square test, or Fisher's exact test if any of the values of the tetra-table is equal or less than 5, for qualitative variables. For the quantitative variables an analysis of equality of variance of Levene will be made, and if the results have a normal behavior, the Student's T test will be performed, otherwise it will be analyzed with the Man Withney U test. For the intra-group analysis, the response variables before and after the treatment assigned by randomization will be included, and for the analysis of the quantitative variables, the Student's T test for related samples and the Chi-square test or Fisher's Exact test will be used for the qualitative. Any P value less than 0.05 will be considered statistically significant. The results will be captured in a database in Excel for Windows. For the statistical analysis, the SPSS program for Windows version 23 will be used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated in the rehabilitation medicine service of the Specialties Hospital National Medical Center of the West.
  • Men and women with clinical and radiographic diagnosis of chondromalacia patellae with or without gonarthrosis.
  • Age over 25 years
  • Patients expressed their signed consent to participate in the study....

排除标准

  • Patients who have been infiltrated with corticosteroids in the knee during the last year.
  • Septic arthritis.
  • Systemic infection or cutaneous infection at the site of infiltration.
  • Systemic inflammatory disease.
  • Joint instability (ligament injuries).
  • Meniscopathies
  • Intra-articular fracture
  • Coagulation disorder or treatment with anticoagulants.
  • Diabetes mellitus poorly controlled (> 130mg / dL).
  • Badly controlled systemic arterial hypertension (> 140 / 90mmHg).
  • Hemarthrosis
  • Pregnancy.
  • Patients with cognitive disorders that prevent the follow-up of indications or carry out the program.
  • Patients who do not accept to sign informed consent.

结局指标

主要结局

WOMAC Osteoarthritis Index

时间窗: 6 weeks

The WOMAC Osteoarthritis Index is a specific instrument for osteoarthrosis. It was developed to have a standard and internationally valid measuring instrument to evaluate the results in clinical trials of knee and hip osteoarthritis treatments preferably. It selects three important concepts for the patient and independent of the observer: pain, rigidity and functional capacity. The WOMAC Osteoarthritis Index is obtained from a questionnaire that uses a visual analogical scale for the evaluation of pain (6 questions), rigidity (2 questions) and physical function (17 questions). The best score for each item is 0, using an analog visual scale of 10 centimeters.

次要结局

未报告次要终点

研究者

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

GONZALEZ-OJEDA ALEJANDRO

Full time surgical researcher

Instituto Mexicano del Seguro Social

研究点 (2)

Loading locations...

相似试验