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Ultrasound and Exercises in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Group I

Group II

Group III

Group IV

Group V

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Ultrasonic Therapy, Exercise Therapy, Randomized controlled trial.

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group I

Group II

Group III

Group IV

Group V

Arm Description

(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)

(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)

(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)

(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)

(patients received only exercise sessions three times a week for eight weeks)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

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.

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.

Full Information

NCT ID

NCT03676790

First Posted

September 17, 2018

Last Updated

July 15, 2019

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03676790

Brief Title

Ultrasound and Exercises in Knee Osteoarthritis

Official Title

Effect of Ultrasound Associated to Exercises in Patients With Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

January 1, 2016 (Actual)

Study Completion Date

January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee, Ultrasonic Therapy, Exercise Therapy, Randomized controlled trial.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

(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)

Arm Title

Group II

Arm Type

Experimental

Arm Description

(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)

Arm Title

Group III

Arm Type

Experimental

Arm Description

(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)

Arm Title

Group IV

Arm Type

Experimental

Arm Description

(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)

Arm Title

Group V

Arm Type

Experimental

Arm Description

(patients received only exercise sessions three times a week for eight weeks)

Intervention Type

Other

Intervention Name(s)

Group I

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Group II

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Group III

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Group IV

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Group V

Intervention Description

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).

Primary Outcome Measure Information:

Title

Pain Intensity Measure

Description

Time Frame

eight weeks

Secondary Outcome Measure Information:

Title

Functionality Measure

Description

Time Frame

eight weeks

Title

Range of motion

Description

Range of motion for flexion of the knees was measured with the universal goniometer (AESCULAP), according to the methods described by Marques.

Time Frame

eight weeks

Title

Muscular strength

Description

Time Frame

eight weeks

Title

Activity

Description

Time Frame

eight weeks

Title

Mobility and balance

Description

Time Frame

eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raquel A Casarotto, PhD

Organizational Affiliation

São Paulo University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Ultrasound and Exercises in Knee Osteoarthritis

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