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Neuroprolotherapy With Physical Therapy for Treatment of Patellar Chondromalacia

Primary Purpose

Chondromalacia Patellae

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Prolotherapy
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chondromalacia Patellae

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Médico Nacional de Occidente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

WOMAC Osteoarthritis Index
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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2018
Last Updated
September 29, 2023
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT03515720
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondromalacia Patellae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prolotherapy
Other Intervention Name(s)
Neural prolotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
WOMAC Osteoarthritis Index
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cleotilde Fuentes Orozco, PhD, MD
Organizational Affiliation
High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Mares País, MD
Organizational Affiliation
High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Angélica García Triana, MD
Organizational Affiliation
Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Fernanda Toro Sashida, MD
Organizational Affiliation
Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco José Barbosa Camacho, MD
Organizational Affiliation
High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Médico Nacional de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44329
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23269956
Citation
Kim YM, Joo YB. Patellofemoral osteoarthritis. Knee Surg Relat Res. 2012 Dec;24(4):193-200. doi: 10.5792/ksrr.2012.24.4.193. Epub 2012 Nov 29.
Results Reference
background
Citation
Weglein A. Neural prolotherapy Wonder Why? Journal of Prolotherapy. May 2011; 3(2): 639-643.
Results Reference
background
Citation
Hauser R, Maddela H, Alderman D, Baehnisch G, Banner R, Blakemore P et al. Journal of Prolotherapy International Medical Editorial Board Consensus Statement on the Use of Prolotherapy for Musculoskeletal Pain. Dec 2011;3(4):744.
Results Reference
background
PubMed Identifier
10710805
Citation
Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80.
Results Reference
background
PubMed Identifier
24596471
Citation
Hauser RA, Sprague IS. Outcomes of prolotherapy in chondromalacia patella patients: improvements in pain level and function. Clin Med Insights Arthritis Musculoskelet Disord. 2014 Feb 17;7:13-20. doi: 10.4137/CMAMD.S13098. eCollection 2014.
Results Reference
background
PubMed Identifier
11831127
Citation
Haspl M, Dubravcic-Simunjak S, Bojanic I, Pecina M. [Anterior knee pain associated with sports and work]. Arh Hig Rada Toksikol. 2001 Dec;52(4):441-9. Croatian.
Results Reference
background
PubMed Identifier
28553139
Citation
Rezasoltani Z, Taheri M, Mofrad MK, Mohajerani SA. Periarticular dextrose prolotherapy instead of intra-articular injection for pain and functional improvement in knee osteoarthritis. J Pain Res. 2017 May 17;10:1179-1187. doi: 10.2147/JPR.S127633. eCollection 2017.
Results Reference
background
PubMed Identifier
28920043
Citation
Maniquis-Smigel L, Dean Reeves K, Jeffrey Rosen H, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Anesth Pain Med. 2016 Dec 6;7(1):e42550. doi: 10.5812/aapm.42550. eCollection 2017 Feb.
Results Reference
result
PubMed Identifier
19549615
Citation
Yelland MJ, Sweeting KR, Lyftogt JA, Ng SK, Scuffham PA, Evans KA. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med. 2011 Apr;45(5):421-8. doi: 10.1136/bjsm.2009.057968. Epub 2009 Jun 22.
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Citation
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Citation
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Citation
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Citation
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Results Reference
derived

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Neuroprolotherapy With Physical Therapy for Treatment of Patellar Chondromalacia

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