Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields
Primary Purpose
Knee Osteoarthritis, Knee Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercises
Electromagnetic field therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- diagnosis of knee OA grade II and III
- Body mass index (BMI) of less than 40 kg / m²
- knee pain for at least six months
Exclusion Criteria:
- Severe OA above grade 3
- previous physical therapy for at least 6 months,
- any other affection of the lower limbs (LLL) and lumbar spine,
- obesity (BMI> 40),
- patients with cardiovascular, metabolic, neurological, oncological or history of knee surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Group A - Intervention
Group B - exercises
Group C - Placebo
Group D - Apparatus
Arm Description
Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique
Performed exercises to strengthen the hip and knee muscles
Performed hip and knee strengthening exercises and electromagnetic field therapy with the coplanar Magnetron® technique, but with the device switched off
Only use electromagnetic field therapy with the coplanar Magnetron® technique
Outcomes
Primary Outcome Measures
Pain
Visual Analog Pain Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03421249
First Posted
January 8, 2018
Last Updated
January 29, 2018
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03421249
Brief Title
Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields
Official Title
Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields: Blinded and Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a randomized controlled clinical trial using a blind evaluator. Fifty-one volunteers were selected from 50 years to 70 years, obeying the following criteria: diagnosis of knee OA grade II and III through the radiographic classification of Kellgreen and Lawrence 1955, Body mass index (BMI) less than 40 kg / m², volunteers should have had knee pain for at least six months. All are from the Rehabilitation Sector of Santa Casa de Misericórdia de São Paulo (ISCMSP). The subjects were evaluated through a questionnaire developed by the authors of the study (Annex I), the Visual Analogue Scale (EVA) (Annex II), then applied to the Lower Extremity Functional Scale LEFS (Appendix III) and the Activities of daily living scale ADLs (Annex IV). In addition, the evaluation of muscular strength was through dynamometry using the Lafayete dynamometer model 01163, which was performed by a blind evaluator regarding the group that will belong to each candidate. The muscles tested were: quadriceps, ischiostibial and gluteus maximus. The randomization was through 60 brown envelopes divided into A, B, C and D, designating the randomness of the sample.
In addition to the initial evaluation, an evaluation was performed at the end of the tenth session and after 3 months of treatment.
The volunteers underwent a five-week treatment program, totaling 10 sessions, divided into four groups, group A - Intervention (INT) underwent knee and hip muscle strengthening exercises and electromagnetic field therapy with (Meditea - ARG) using the coplanar technique, group B - Exercises (EXE) carried out exercises to strengthen the hip and knee muscles in the C - Placebo group (PLA). hip and knee and electromagnetic field therapy with the Magnetron® coplanar technique, but with the device switched off and group D - Apparatus (APA) only use electromagnetic field therapy with the magnetron® coplanar technique. In the present study, there were no significant differences between groups regarding pain, function and muscle strength. However, group A obtained better results in the evaluated criteria, tending that the combination PEMF and exercises, is an indicated treatment for OA knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A - Intervention
Arm Type
Active Comparator
Arm Description
Submitted to knee and hip muscle strengthening exercises and electromagnetic field therapy with Magnetron ® (Meditea - ARG) using the coplanar technique
Arm Title
Group B - exercises
Arm Type
Active Comparator
Arm Description
Performed exercises to strengthen the hip and knee muscles
Arm Title
Group C - Placebo
Arm Type
Placebo Comparator
Arm Description
Performed hip and knee strengthening exercises and electromagnetic field therapy with the coplanar Magnetron® technique, but with the device switched off
Arm Title
Group D - Apparatus
Arm Type
Active Comparator
Arm Description
Only use electromagnetic field therapy with the coplanar Magnetron® technique
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
Muscle strengthening exercises of the hip and knee muscles
Intervention Type
Other
Intervention Name(s)
Electromagnetic field therapy
Intervention Description
Electromagnetic field therapy with Magnetron®
Primary Outcome Measure Information:
Title
Pain
Description
Visual Analog Pain Scale
Time Frame
The visual analog pain scale was performed without onset and after 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of knee OA grade II and III
Body mass index (BMI) of less than 40 kg / m²
knee pain for at least six months
Exclusion Criteria:
Severe OA above grade 3
previous physical therapy for at least 6 months,
any other affection of the lower limbs (LLL) and lumbar spine,
obesity (BMI> 40),
patients with cardiovascular, metabolic, neurological, oncological or history of knee surgery.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28770628
Citation
Added MAN, Added C, Kasawara KT, Rotta VP, de Freitas DG. Effects of a Knee Brace With a Patellar Hole Versus Without a Patellar Hole in Patients With Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial. Eval Health Prof. 2018 Dec;41(4):512-523. doi: 10.1177/0163278717714307. Epub 2017 Jun 30.
Results Reference
result
Learn more about this trial
Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields
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