Ultrasound and Exercises in Knee Osteoarthritis

NCT ID: NCT03676790

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-01-01

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

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 Type: EXPERIMENTAL

Group I

Intervention Type: OTHER

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 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 Type: EXPERIMENTAL

Group II

Intervention Type: OTHER

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 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 Type: EXPERIMENTAL

Group III

Intervention Type: OTHER

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 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 Type: EXPERIMENTAL

Group IV

Intervention Type: OTHER

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 V

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

Group Type: EXPERIMENTAL

Group V

Intervention Type: OTHER

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).

Interventions

Group I

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

Group II

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

Group III

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

Group IV

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

Group V

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Raquel A. Casarotto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel A Casarotto, PhD

Role: PRINCIPAL_INVESTIGATOR

São Paulo University

Other Identifiers

CAAE: 47955315.7.0000.0065

Identifier Type: -

Identifier Source: org_study_id