Ultrasound and Exercises in Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Other: Group IVOther: Group IOther: Group VOther: Group IIOther: Group III
- Registration Number
- NCT03676790
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group IV 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 I 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 V Group V (patients received only exercise sessions three times a week for eight weeks) Group II 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 III 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)
- Primary Outcome Measures
Name Time Method Pain Intensity Measure 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 Outcome Measures
Name Time Method Functionality Measure 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).
Range of motion eight weeks Range of motion for flexion of the knees was measured with the universal goniometer (AESCULAP), according to the methods described by Marques.
Muscular strength 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.
Mobility and balance 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.
Activity 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.