Ultrasound and Exercises in Knee Osteoarthritis

University of Sao Paulo General Hospital

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Group II; Other: Group III; Other: Group I; Other: Group IV; Other: Group V

Study type: Interventional

Funder types: Other

Identifiers

NCT03676790

CAAE: 47955315.7.0000.0065

Details and patient eligibility

About

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).

Full 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

Enrollment: 100 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 5 patient groups

Group I

Experimental group

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)

Treatment:

Other: Group I

Group II

Experimental group

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)

Treatment:

Other: Group II

Group III

Experimental group

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)

Treatment:

Other: Group III

Group IV

Experimental group

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)

Treatment:

Other: Group IV

Group V

Experimental group

Description:

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

Treatment:

Other: Group V