Skip to main content
OpenTrials
Completed

NCT Number: NCT03676790

Ultrasound and Exercises in 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group I

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

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

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

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

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functionality Measure

    Time frame: eight weeks

    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).

  2. Range of motion

    Time frame: eight weeks

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

  3. Muscular strength

    Time frame: eight weeks

    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.

  4. Activity

    Time frame: eight weeks

    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.

  5. Mobility and balance

    Time frame: eight weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Effect of Ultrasound Associated to Exercises in Patients With Knee Osteoarthritis

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 19, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.