Influence of Using Physical Therapy Resources for Knee Osteoarthritis

NCT ID: NCT02636764

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Physical Therapy Modalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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exercise group

An 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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

exercise group + Ultrasound therapy

Apart from intervening in the exercise group, an ultrasound device is used .

Group Type PLACEBO_COMPARATOR

exercise

Intervention Type OTHER

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Ultrasound therapy

Intervention Type DEVICE

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.

exercise group + interferential current

Besides 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.

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

interferential current

Intervention Type DEVICE

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

exercise group + short-wave diathermy

Besides 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.

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

short-wave diathermy

Intervention Type DEVICE

Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy

exercise group + Low level laser therapy

Apart 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.

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Low level laser therapy

Intervention Type DEVICE

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.

Interventions

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exercise

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Intervention Type OTHER

interferential current

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

Intervention Type DEVICE

short-wave diathermy

Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy

Intervention Type DEVICE

Low level laser therapy

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.

Intervention Type DEVICE

Ultrasound therapy

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Cid André Fidelis de Paula Gomes

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cid André Fidelis de Paula Gomes, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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University of Nove de Julho

São Paulo, São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 32312265 (View on PubMed)

Related Links

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Other Identifiers

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51391715.1.0000.5511

Identifier Type: -

Identifier Source: org_study_id

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