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Neuroprolotherapy With Physical Therapy for Treatment of Patellar Chondromalacia

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ClinicalTrials.gov Identifier: NCT03515720
Recruitment Status : Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social

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.

Condition or disease Intervention/treatment Phase
Chondromalacia Patellae Procedure: Prolotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Neuroprolotherapy With Home Physical Therapy Against Isolated Physical Therapy for the Treatment of Patellar Chondromalacia
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : March 1, 2020

Arm Intervention/treatment
Experimental: Study group
Painful points will be located in the path of the sensory nerves of the knee in which asepsis and antisepsis will be performed, and then 0.5-1 ml of 5% dextrose solution will be applied subcutaneously at a 45º angle along the way. of the nerve with a 27 gauge needle of ½ inch. The number of injections will vary according to the symptoms to be treated. The application will be made once a week for 6 weeks. After the first application of neuroprolotherapy, the patient will be trained to perform a rehabilitation therapy program based on thermotherapy, kinesitherapy and knee strengthening exercises. At the end of the 6 sessions, a new assessment will be made with the WOMAC, EVA and measurement of movement arcs to assess the evolution after treatment.
Procedure: Prolotherapy
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 Name: Neural prolotherapy

No Intervention: Control group
Physical therapy consisting of 10 sessions based on thermotherapy, kinesitherapy and muscle strengthening exercises to the knee. Subsequently, the patient will perform this therapy home until completing 6 weeks. At the end a new assessment will be made with measurement of movement arcs, WOMAC scale and EVA to assess the evolution after treatment.



Primary Outcome Measures :
  1. WOMAC Osteoarthritis Index [ Time Frame: 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.



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515720


Contacts
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Contact: Alejandro González Ojeda, PhD,MD,FACS 36170060 ext 31384 avygail5@yahoo.com.mx

Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: Cleotilde Fuentes Orozco, PhD, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Roberto Mares País, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Sandra Angélica García Triana, MD Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: María Fernanda Toro Sashida, MD Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Francisco José Barbosa Camacho, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

Publications of Results:
Other Publications:
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Responsible Party: Alejandro Gonzalez-Ojeda, Full time surgical researcher, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03515720     History of Changes
Other Study ID Numbers: Neuroproloterapia_2018
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cartilage Diseases
Chondromalacia Patellae
Musculoskeletal Diseases
Connective Tissue Diseases