Clinical trial NCT03676790: Ultrasound and Exercises in Knee Osteoarthritis
Official title: Effect of Ultrasound Associated to Exercises in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Ultrasonic Therapy
Exercise Therapy
Randomized controlled trial.
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pain Intensity Measure
timeFrame: eight weeks
Secondary outcomes:
measure: Functionality Measure
timeFrame: eight weeks
measure: Range of motion
timeFrame: eight weeks
measure: Muscular strength
timeFrame: eight weeks
measure: Activity
timeFrame: eight weeks
measure: Mobility and balance
timeFrame: eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: São Paulo University
name: Raquel A Casarotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: