Clinical trial NCT03515720: Neuroprolotherapy With Physical Therapy for Treatment of Patellar Chondromalacia
Official title: Effectiveness of Neuroprolotherapy With Home Physical Therapy Against Isolated Physical Therapy for the Treatment of Patellar Chondromalacia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chondromalacia Patellae
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2018-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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....

Exclusion Criteria:

* 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.

Primary outcomes:
measure: WOMAC Osteoarthritis Index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Médico Nacional de Occidente
state: Jalisco
Study officials:
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Cleotilde Fuentes Orozco, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Roberto Mares País, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Sandra Angélica García Triana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: María Fernanda Toro Sashida, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Francisco José Barbosa Camacho, MD
role: PRINCIPAL_INVESTIGATOR
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