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CompletedNCT02636764osteoarthritisUpdated Feb 19, 2018

Influence of Using Physical Therapy Resources for Knee Osteoarthritis

An interventional study of exercise and interferential current in Osteoarthritis and Physical Therapy Modalities, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis
  • Physical Therapy Modalities

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03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    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.

    Other: exercise

  • Placebo comparator
    exercise group + Ultrasound therapy

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

    Other: exercise · Device: Ultrasound therapy

  • Experimental
    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.

    Other: exercise · Device: interferential current

  • Experimental
    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.

    Other: exercise · Device: short-wave diathermy

  • Experimental
    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.

    Other: exercise · Device: Low level laser therapy

Interventions

  • Otherexercise

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

  • Deviceinterferential 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

  • Deviceshort-wave diathermy

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

  • DeviceLow 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.

  • DeviceUltrasound 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.

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What researchers measure

Primary outcomes

  1. pain

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

    Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks

  2. stiffness

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

    Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks

  3. physical functional

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

    Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks

Secondary outcomes

  1. intensity of pain

    The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.

    Time frame: Change from Baseline in The Numerical rating pain scale at 8 weeks

  2. Self-perceived fatigue

    a visual analog scale (VAS-F).

    Time frame: Change from Baseline in the self-perceived fatigue at 8 weeks

  3. Functional capacity for sitting and standing

    sitting-rising test

    Time frame: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks

  4. level of pressure pain

    Pressure Pain Threshold in the knee with algometer dynamometer.

    Time frame: Change from Baseline in ThePressure Pain Threshold at 8 weeks

  5. Self-perceived fatigue

    The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).

    Time frame: Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks

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Study locations

1 site
  • University of Nove de Julho
    São Paulo, São Paulo, São Paulo 01504-001, Brazil
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References and documents

Publications

  • 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. PubMed 32312265 ↗

Related links

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2016, a primary completion of Sep 2017 and a completion of Feb 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2015
First posted
Dec 22, 2015
Start
Dec 2016
Primary completionActual
Sep 2017
CompletionActual
Feb 2018
Last update
Feb 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02636764
Responsible party
Cid André Fidelis de Paula Gomes (Phd, University of Nove de Julho) — Principal investigator
First posted
Dec 22, 2015
Start date
Dec 2016
Primary completion
Sep 2017
Completion
Feb 2018
Last update
Feb 19, 2018

Study contacts

Cid André Fidelis de Paula Gomes, Phd
principal investigator · University of Nove de Julho

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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