Neuroprolotherapy With Physical Therapy for Treatment of Patellar Chondromalacia
Condition: Chondromalacia Patellae
MeSH terms: Cartilage Diseases; Chondromalacia Patellae
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Prolotherapy
Intervention type(s): Procedure
Intervention description(s): It consists of injecting 5% dextrose in sterile aqueous solution without the use of lidocaine in a subcutaneous nerve to inhibit neurogenic inflammation and the release of substance P and CGRP, decreasing neurogenic inflammation.
Other intervention name(s): Neural prolotherapy
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment