Ultrasound and Exercises in Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Effect of Ultrasound Associated to Exercises in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676790
• Other study ID #: CAAE: 47955315.7.0000.0065
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: January 1, 2017

Study information

• Verified date: July 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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).
• 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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	eight weeks
Secondary	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).	eight weeks
Secondary	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.	eight weeks
Secondary	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.	eight weeks
Secondary	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.	eight weeks
Secondary	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.	eight weeks