Ultrasound and Exercises in Knee Osteoarthritis

NCT03676790 | Completed

• 1 other identifier: CAAE: 47955315.7.0000.0065
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Ultrasonic Therapy; Exercise Therapy; Randomized controlled trial.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functionality Measure

  eight weeks

• Range of motion

  eight weeks

• Muscular strength

  eight weeks

• Activity

  eight weeks

• Mobility and balance

  eight weeks

Study Arms (5)

Group I

EXPERIMENTAL

(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)

Other: Group I

Group II

EXPERIMENTAL

(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)

Other: Group II

Group III

EXPERIMENTAL

(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)

Other: Group III

Group IV

EXPERIMENTAL

(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)

Other: Group IV

Group V

EXPERIMENTAL

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

Other: Group V

Interventions

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 I

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 II

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 III

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 IV

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).

Group V

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Raquel A Casarotto, PhD

  São Paulo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share