OsteoarthritisosteoarthritisNCT02636764

Influence of Using Physical Therapy Resources for Knee Osteoarthritis

A study testing exercise, interferential current and short-wave diathermy in people with Osteoarthritis and Physical Therapy Modalities, run by University of Nove de Julho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis, Physical Therapy Modalities
What is being tested?: exercise, interferential current and short-wave diathermy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteBrazil
Study dates: Dec 2016to Feb 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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,

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

University of Nove de Julho
São Paulo, São Paulo, São Paulo, 01504-001

Other trials in Brazil

About this study

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.

Conditions: Osteoarthritis, Physical Therapy Modalities
Being tested: exercise, interferential current, short-wave diathermy, Low level laser therapy, Ultrasound therapy
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exerciseOther
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
interferential currentDevice
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
short-wave diathermyDevice
Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
Low level laser therapyDevice
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 therapyDevice
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.

Study groups in NCT02636764
Study group	Role	What they receive
exercise group	Active comparator	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. Receives: Other: exercise
exercise group + Ultrasound therapy	Placebo comparator	Apart from intervening in the exercise group, an ultrasound device is used . Receives: Other: exercise; Device: Ultrasound therapy
exercise group + interferential current	Experimental	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. Receives: Other: exercise; Device: interferential current
exercise group + short-wave diathermy	Experimental	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. Receives: Other: exercise; Device: short-wave diathermy
exercise group + Low level laser therapy	Experimental	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. Receives: Other: exercise; Device: Low level laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

pain
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Measured: 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.
Measured: 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.
Measured: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks

Secondary outcomes (5)

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'.
Measured: Change from Baseline in The Numerical rating pain scale at 8 weeks
Self-perceived fatigue
a visual analog scale (VAS-F).
Measured: Change from Baseline in the self-perceived fatigue at 8 weeks
Functional capacity for sitting and standing
sitting-rising test
Measured: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
level of pressure pain
Pressure Pain Threshold in the knee with algometer dynamometer.
Measured: Change from Baseline in ThePressure Pain Threshold at 8 weeks
Self-perceived fatigue
The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).
Measured: Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Feb 2018

First posted22 Dec 2015 (estimated)
Study startDec 2016
Primary completionSep 2017
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02636764
Sponsor's protocol ID: 51391715.1.0000.5511
Acronym: osteoarthritis
Status last verified: Feb 2018
First submitted: 10 Dec 2015
Last updated: 19 Feb 2018
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Using Physical Therapy Resources for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT02636764
Acronym / sponsor ID: osteoarthritis / 51391715.1.0000.5511
Conditions: Osteoarthritis, Physical Therapy Modalities
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of Nove de JulhoUniversity, hospital or other
Study start: Dec 2016
Primary completion: Sep 2017 (actual)
Study completion: Feb 2018 (actual)
First posted: 22 Dec 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
exercise group	Active comparator	Other: exerciseAn 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 comparator	Other: exercise, Device: Ultrasound therapyApart from intervening in the exercise group, an ultrasound device is used .
exercise group + interferential current	Experimental	Other: exercise, Device: interferential currentBesides 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	Experimental	Other: exercise, Device: short-wave diathermyBesides 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	Experimental	Other: exercise, Device: Low level laser therapyApart 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.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exerciseexercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.	Other	exercise group, exercise group + Low level laser therapy, exercise group + Ultrasound therapy, exercise group + interferential current, exercise group + short-wave diathermy
interferential currentThe 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	Device	exercise group + interferential current
short-wave diathermyIs a modality that produces deep heating via conversion of electromagnetic energy to thermal energy	Device	exercise group + short-wave diathermy
Low level laser therapyLaser 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.	Device	exercise group + Low level laser therapy
Ultrasound therapyUltrasound (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.	Device	exercise group + Ultrasound therapy

Primary outcome

pain
Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
stiffness
Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
physical functional
Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

5 secondary outcomes

intensity of pain
Time frame: Change from Baseline in The Numerical rating pain scale at 8 weeks
Self-perceived fatigue
Time frame: Change from Baseline in the self-perceived fatigue at 8 weeks
Functional capacity for sitting and standing
Time frame: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
level of pressure pain
Time frame: Change from Baseline in ThePressure Pain Threshold at 8 weeks
Self-perceived fatigue
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Derived from this study: PubMed 32312265de 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.
Related InfoLink provided by the sponsor.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cid André Fidelis de Paula Gomes, Phd principal investigator

University of Nove de Julho

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing exercise, interferential current and short-wave diathermy in people with Osteoarthritis and Physical Therapy Modalities, run by University of Nove de Julho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain (time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02636764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.