Osteoarthritis, KneeNCT03676790

Ultrasound and Exercises in Knee Osteoarthritis

A study testing Group I, Group II and Group III in people with Osteoarthritis, Knee, run by University of Sao Paulo General Hospital.

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 50 to 75 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Group I, Group II and Group III
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 1 Jan 2015to 1 Jan 2017
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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To be included in the study, participants needed to suffer knee osteoarthritis with osteoarthritis levels 2 - 4 according to Kellgren-Lawrence grade12, be aged between 50 and 75 years and suffer knee pain and functional disability for at least three months, according to the criteria of the American College for Rheumatology (ACR)13. Participants from both genders were included. The Kellgren and Lawrence grading of knee osteoarthritis is as follows: none (0), doubtful (1), minimal (2), moderate (3) and severe (4).
The ACR criteria of knee osteoarthritis are as follows:
Using history and physical examination: knee pain and three of the following - over 50 years old; less than 30 minutes of morning stiffness; bone tenderness; bone enlargement; no palpable warmth of synovial.
Using history, physical examination and radiographic findings: knee pain and one of the following - over 50 years old; less than 30 minutes of morning stiffness; crepitus on active motion; and osteophytes.
Using history, physical examination and laboratory findings: knee pain and five of the following - over 50 years old; less than 30 minutes of morning stiffness; bone tenderness; bone enlargement; no palpable warmth of synovial; crepitus on active motion; ESR <40 mm/h; rheumatoid factor <1: 40; synovial fluid sign of osteoarthritis.

Who cannot join

Participants were excluded if they had cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrollment.

About this study

Official title: Effect of Ultrasound Associated to Exercises in Patients With Knee Osteoarthritis

The aim of this investigation is to compare the effects of continuous (CUS) and pulsed (PUS) ultrasound associated with a program of exercises on pain, range of motion, muscle strength, functionality, mobility and activity in patients with knee osteoarthritis. Participants were randomized into five groups: Group I (in the first month, continuous ultrasound was applied), Group II (in the first month, pulsed ultrasound was applied), Group III (in the first and second month, the continuous ultrasound was applied), Group IV (in the first and second month, the pulsed ultrasound was applied) and Group V (patients received only exercise sessions for eight weeks).

Read the detailed description

Strong evidence suggests that joint exercises reduce pain and disability in patients with osteoarthritis. There is evidence that exercise is responsible for muscular strengthening and better flexibility, improved global function as well as better performance in activities of daily living (ADL).

There are two modes of US, continuous and pulsed. Continuous US (CUS) generates thermal effects by stimulating the process of tissue regeneration, changing cell membrane permeability and increasing intracellular calcium, while pulsed US (PUS) mainly produces non-thermal effects to increase tissue metabolism, enhance fibrous tissue extensibility and elevate pain threshold

Conditions: Osteoarthritis, Knee
Being tested: Group I, Group II, Group III, Group IV, Group V
Keywords: Osteoarthritis, Knee, Ultrasonic Therapy, Exercise Therapy, Randomized controlled trial.
Medical subject headings: Osteoarthritis, Knee

What participants receive

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

Group IOther
Group I In the first month, continuous ultrasound was applied three times a week. In the second month, patients performed only exercise sessions three times a week. In the ultrasound treatment, the following parameters were used: frequency of 1 MHz, intensity of 1.5 W/cm2 (temporal and spatial mean SATA), duty cycle of 100%, with application time of 5 minutes on the medial side and 5 minutes on lateral side of knee.
Exercises
The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
- 10 minutes warming-up (treadmill, ergometer bike or rowing machine);
- 30 minutes 2-3 sets with P-1, P-2 or P-3;
- 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).
Group IIOther
Group II In the first month, pulsed ultrasound was applied three times a week. In the second month, patients performed only exercise sessions three times a week. In the treatment with the US, the following parameters were used: 1 MHz frequency, 2.5 w / cm2 intensity (temporal and spatial mean SATA), pulsed mode (25%), 5 minutes on the medial side and 5 minutes on the lateral side of the knee.
Exercises
The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
- 10 minutes warming-up (treadmill, ergometer bike or rowing machine);
- 30 minutes 2-3 sets with P-1, P-2 or P-3;
- 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).
Group IIIOther
Group III In the first month, the continuous ultrasound was applied 3 times a week. In the second month, 3 times a week, the continuous ultrasound was applied associated with exercises. The parameters were used: frequency of 1 MHz, intensity of 1.5 w / cm2 (temporal and spatial mean SATA), continuous mode (100%), with application time of 5 minutes on the medial side and 5 minutes on lateral side of knee.
Exercises
The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
- 10 minutes warming-up (treadmill, ergometer bike or rowing machine);
- 30 minutes 2-3 sets with P-1, P-2 or P-3;
- 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).
Group IVOther
Group IV In the first month, the pulsed ultrasound was applied three times a week. In the second month, three times a week, the pulsed ultrasound associated with exercises was applied. In the treatment with the US, the following parameters were used: 1 MHz frequency, 2.5 w / cm2 intensity (temporal and spatial mean SATA), pulsed mode (25%), 5 minutes on the medial side and 5 Minutes on the lateral side of the knee.
Exercises
The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
- 10 minutes warming-up (treadmill, ergometer bike or rowing machine);
- 30 minutes 2-3 sets with P-1, P-2 or P-3;
- 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).
Group VOther
Group V Patients received only exercise sessions three times a week for two months.
Exercises
The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
- 10 minutes warming-up (treadmill, ergometer bike or rowing machine);
- 30 minutes 2-3 sets with P-1, P-2 or P-3;
- 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).

Study groups in NCT03676790
Study group	Role	What they receive
Group I	Experimental	(in the first month, continuous ultrasound was applied three times a week and in the second month patients performed only exercise sessions three times a week) Receives: Other: Group I
Group II	Experimental	(in the first month, pulsed ultrasound was applied three times a week and in the second month patients performed only exercise sessions three times a week) Receives: Other: Group II
Group III	Experimental	(in the first month, the continuous ultrasound was applied three times a week and in the second month, three times a week, the continuous ultrasound associated with exercises was applied) Receives: Other: Group III
Group IV	Experimental	(in the first month, the pulsed ultrasound was applied three times a week and in the second month, three times a week, the pulsed ultrasound associated with exercises was applied) Receives: Other: Group IV
Group V	Experimental	(patients received only exercise sessions three times a week for eight weeks) Receives: Other: Group V

What is being measured

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

Pain Intensity Measure
Pain was assessed using a visual analogue scale (VAS)14 consisting of a 10 cm rule (without numbers). At the left side, 'no pain' is written, while on the right side, 'unbearable pain'. Patients were instructed to mark on the rule what their level of pain was.
Measured: eight weeks

Secondary outcomes (5)

Functionality Measure
Functionality was measured using the Lequesne questionnaire,14 which consists of 11 questions about pain, discomfort and function. Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).
Measured: eight weeks
Range of motion
Range of motion for flexion of the knees was measured with the universal goniometer (AESCULAP), according to the methods described by Marques.
Measured: eight weeks
Muscular strength
Muscular strength was estimated at maximal isometric force for the quadriceps, using a portable dynamometer (Lafayette, USA). Under stabilized conditions, patients, sitting with knees flexed at 10o, 60o and 90o (measured by a goniometer),16 were asked to extend the legs as far as they could. Three trials were conducted and the mean value was obtained.
Measured: eight weeks
Activity
Activity was measured using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire,17 which is self-administered and measures pain, frozen joints and physical activity. Increased scores indicate decreased activity.
Measured: eight weeks
Mobility and balance
Mobility and balance are evaluated by Timed Get Up and Go (TGUG)18 and 8 meters Test19. The TGUG quantifies in seconds the functional mobility through the time that the individual needs to perform the task of getting up from a chair, walking three meters, turning back towards the chair and sitting again. The 8-meter test measures the time and number of steps required for a person to walk for 8 meters.
Measured: eight weeks

Timeline

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

1 Jan 20151 Jan 2017

First posted19 Sep 2018
Study start1 Jan 2015
Primary completion1 Jan 2016
Study completion1 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03676790
Sponsor's protocol ID: CAAE: 47955315.7.0000.0065
Status last verified: Jul 2019
First submitted: 17 Sep 2018
Last updated: 18 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

Official record

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Ultrasound Associated to Exercises in Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT03676790
Acronym / sponsor ID: CAAE: 47955315.7.0000.0065
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee, Ultrasonic Therapy, Exercise Therapy, Randomized controlled trial.
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of Sao Paulo General HospitalUniversity, hospital or other
Study start: 1 Jan 2015 (actual)
Primary completion: 1 Jan 2016 (actual)
Study completion: 1 Jan 2017 (actual)
First posted: 19 Sep 2018 (actual)
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.

Detailed description

Study design

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

Arm	Type	Receives
Group I	Experimental	Other: Group I(in the first month, continuous ultrasound was applied three times a week and in the second month patients performed only exercise sessions three times a week)
Group II	Experimental	Other: Group II(in the first month, pulsed ultrasound was applied three times a week and in the second month patients performed only exercise sessions three times a week)
Group III	Experimental	Other: Group III(in the first month, the continuous ultrasound was applied three times a week and in the second month, three times a week, the continuous ultrasound associated with exercises was applied)
Group IV	Experimental	Other: Group IV(in the first month, the pulsed ultrasound was applied three times a week and in the second month, three times a week, the pulsed ultrasound associated with exercises was applied)
Group V	Experimental	Other: Group V(patients received only exercise sessions three times a week for eight weeks)

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

To be included in the study, participants needed to suffer knee osteoarthritis with osteoarthritis levels 2 - 4 according to Kellgren-Lawrence grade12, be aged between 50 and 75 years and suffer knee pain and functional disability for at least three months, according to the criteria of the American College for Rheumatology (ACR)13. Participants from both genders were included. The Kellgren and Lawrence grading of knee osteoarthritis is as follows: none (0), doubtful (1), minimal (2), moderate (3) and severe (4).
Using history and physical examination: knee pain and three of the following - over 50 years old; less than 30 minutes of morning stiffness; bone tenderness; bone enlargement; no palpable warmth of synovial.
Using history, physical examination and radiographic findings: knee pain and one of the following - over 50 years old; less than 30 minutes of morning stiffness; crepitus on active motion; and osteophytes.
Using history, physical examination and laboratory findings: knee pain and five of the following - over 50 years old; less than 30 minutes of morning stiffness; bone tenderness; bone enlargement; no palpable warmth of synovial; crepitus on active motion; ESR <40 mm/h; rheumatoid factor <1: 40; synovial fluid sign of osteoarthritis.

Key exclusion criteria (1 listed)

Participants were excluded if they had cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrollment.

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
Group IGroup I In the first month, continuous ultrasound was applied three times a week. In the second month, patients performed only exercise sessions three times a week. In the ultrasound treatment, the following parameters were used: frequency of 1 MHz, intensity of 1.5 W/cm2 (temporal and spatial mean SATA), duty cycle of 100%, with application time of 5 minutes on the medial side and 5 minutes on lateral side of knee. Exercises The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes: * 10 minutes warming-up (treadmill, ergometer bike or rowing machine); * 30 minutes 2-3 sets with P-1, P-2 or P-3; * 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).	Other	Group I
Group IIGroup II In the first month, pulsed ultrasound was applied three times a week. In the second month, patients performed only exercise sessions three times a week. In the treatment with the US, the following parameters were used: 1 MHz frequency, 2.5 w / cm2 intensity (temporal and spatial mean SATA), pulsed mode (25%), 5 minutes on the medial side and 5 minutes on the lateral side of the knee. Exercises The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes: * 10 minutes warming-up (treadmill, ergometer bike or rowing machine); * 30 minutes 2-3 sets with P-1, P-2 or P-3; * 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).	Other	Group II
Group IIIGroup III In the first month, the continuous ultrasound was applied 3 times a week. In the second month, 3 times a week, the continuous ultrasound was applied associated with exercises. The parameters were used: frequency of 1 MHz, intensity of 1.5 w / cm2 (temporal and spatial mean SATA), continuous mode (100%), with application time of 5 minutes on the medial side and 5 minutes on lateral side of knee. Exercises The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes: * 10 minutes warming-up (treadmill, ergometer bike or rowing machine); * 30 minutes 2-3 sets with P-1, P-2 or P-3; * 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).	Other	Group III
Group IVGroup IV In the first month, the pulsed ultrasound was applied three times a week. In the second month, three times a week, the pulsed ultrasound associated with exercises was applied. In the treatment with the US, the following parameters were used: 1 MHz frequency, 2.5 w / cm2 intensity (temporal and spatial mean SATA), pulsed mode (25%), 5 minutes on the medial side and 5 Minutes on the lateral side of the knee. Exercises The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes: * 10 minutes warming-up (treadmill, ergometer bike or rowing machine); * 30 minutes 2-3 sets with P-1, P-2 or P-3; * 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).	Other	Group IV
Group VGroup V Patients received only exercise sessions three times a week for two months. Exercises The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes: * 10 minutes warming-up (treadmill, ergometer bike or rowing machine); * 30 minutes 2-3 sets with P-1, P-2 or P-3; * 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius).	Other	Group V

Primary outcome

Pain Intensity Measure
Time frame: eight weeks
Pain was assessed using a visual analogue scale (VAS)14 consisting of a 10 cm rule (without numbers). At the left side, 'no pain' is written, while on the right side, 'unbearable pain'. Patients were instructed to mark on the rule what their level of pain was.

5 secondary outcomes

Functionality Measure
Time frame: eight weeks
Range of motion
Time frame: eight weeks
Muscular strength
Time frame: eight weeks
Activity
Time frame: eight weeks
Mobility and balance
Time frame: eight 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 18 Jul 2019.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

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Effect of Anti-inflammatory Diet in Osteoarthritis
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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.

Raquel A Casarotto, PhD principal investigator

São Paulo University

Questions about this trial

What is this clinical trial studying?

A study testing Group I, Group II and Group III in people with Osteoarthritis, Knee, run by University of Sao Paulo General Hospital.

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 5 inclusion and 1 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 Intensity Measure (time frame: eight weeks). 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 NCT03676790.

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 18 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.