Influence of Using Physical Therapy Resources for Knee Osteoarthritis
osteoarthritis
1 other identifier
interventional
100
1 country
1
Brief Summary
Osteoarthritis is a chronic, multifactorial characterization, which changes in bone alignment, cartilage and structures that provide joint stability appear to be strongly correlated with the origin of this disease.This project will aim to verify the effectiveness of interferential current, short wave and low level laser therapy on an exercise program for mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups: exercise group, exercise group + Ultrasound therapy, exercise group + interferential current, exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and after the trial protocol by the following instruments: Western Ontario and McMaster Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical agents in an exercise program will provide an improvement in pain, mobility and knee function in individuals diagnosed with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFebruary 19, 2018
February 1, 2018
9 months
December 10, 2015
February 15, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
pain
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
stiffness
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
physical functional
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Secondary Outcomes (5)
intensity of pain
Change from Baseline in The Numerical rating pain scale at 8 weeks
Self-perceived fatigue
Change from Baseline in the self-perceived fatigue at 8 weeks
Functional capacity for sitting and standing
Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
level of pressure pain
Change from Baseline in ThePressure Pain Threshold at 8 weeks
Self-perceived fatigue
Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks
Study Arms (5)
exercise group
ACTIVE COMPARATORAn exercise protocol drawn up with the objective will be held to strengthen the musculature: flexor and extensor of the knee; extension, abduction, hip side rotator, using the weight and the elastic band.
exercise group + Ultrasound therapy
PLACEBO COMPARATORApart from intervening in the exercise group, an ultrasound device is used .
exercise group + interferential current
EXPERIMENTALBesides the intervention of the exercise group after the exercises will be applied to interferential current through the device. Will be positioned 4 electrodes (8x5 cm), two upper and two lower (forming a square) around the center of the knee.
exercise group + short-wave diathermy
EXPERIMENTALBesides the intervention of the exercise group after the exercises will be applied diathermies short wave in continuous mode. For that will be used apparatus, 27.12 megahertz, by means of vulcanized rubber electrodes (12x17 cm) with gentle warming for 30 minutes.
exercise group + Low level laser therapy
EXPERIMENTALApart from intervening in the exercise group, will be applied to Low level laser therapy, through the laser unit, Class 3b, gallium-aluminum-arsenide, continuous mode, wavelength: 830 nanometer, power: 30 watts.
Interventions
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
The basic principle of Interferential Therapy (IFT) is to utilise the significant physiological effects of low frequency (\<250pps) electrical stimulation of nerves without the associated painful and somewhat unpleasant side effects sometimes associated with low frequency stimulation
Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
Laser treatment in which the energy output is low enough so that the temperature of the treated tissue does not rise above 98.6°F (36.5° C) or normal body temperature.
Ultrasound (US) is a form of mechanical energy, not electrical energy and therefore strictly speaking, not really electrotherapy at all but does fall into the Electro Physical Agents grouping.
Eligibility Criteria
You may qualify if:
- knee pain to at least six months and minimum of 4 points in pain scale
- Diagnosed with osteoarthritis in unilateral knee according to the criteria established by the American College of Rheumatology and confirmed by radiographic examination for identification Kellgren-Lawrence grade 2 or 3 (Kellgren \& Lawrence, 1957).
You may not qualify if:
- Any type of physical therapy
- therapy with intra-articular corticosteroids or therapeutic chondroprotective drugs last year, before the start of the study.
- history of trauma on his knees, cognitive disorder or psychological disorder,
- neurological (sensory or motor)
- cancer
- diabetes,
- or any state of adverse acute health osteoarthritis signs of hip
- cardiopulmonary disease that prevents the conducting exercises
- require auxiliary device for performing gait.
- Yet who undertake physical activity in the last two months. Physical activity is defined as strength training and / or more than 20 minutes of aerobic activity twice a week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nove de Julho
São Paulo, São Paulo, São Paulo, 01504-001, Brazil
Related Publications (1)
de Paula Gomes CAF, Politti F, de Souza Bacelar Pereira C, da Silva ACB, Dibai-Filho AV, de Oliveira AR, Biasotto-Gonzalez DA. Exercise program combined with electrophysical modalities in subjects with knee osteoarthritis: a randomised, placebo-controlled clinical trial. BMC Musculoskelet Disord. 2020 Apr 20;21(1):258. doi: 10.1186/s12891-020-03293-3.
PMID: 32312265DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cid André Fidelis de Paula Gomes, Phd
University of Nove de Julho
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phd
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 22, 2015
Study Start
December 1, 2016
Primary Completion
September 1, 2017
Study Completion
February 1, 2018
Last Updated
February 19, 2018
Record last verified: 2018-02