Skip to main content
OpenTrials
Completed

NCT Number: NCT03705039

Is Pulsed Ultrasound Treatment Effective in Knee Osteoarthritis

Osteoarthritis is a progressive rheumatic disease which is the most common cause of musculoskeletal pain and functional impairment, particularly in the elderly group. The most common form is knee osteoarthritis. Pharmacological, non-pharmacological and if required surgical treatment may be applied in the osteoarthritis treatment. Non-pharmacological treatment includes patient education, joint protective measures, exercise, psychological support, diet, weight loss, physical therapy modalities, use of assistive device, hydrotherapy and balneotherapy. Ultrasound therapy is one of the most commonly used physical modalities in osteoarthritis treatment. İt has a deep heating effect and increases tissue regeneration, blood flow and metabolic effects while reducing the inflammation and relaxing the muscles. İn addition, it increases the cartilage regeneration according to certain in vivo and in vitro studies.

Decelerating the cartilage loss and decreasing the high volume of synovial fluid in early-stage knee osteoarthritis is important to preventing progression of the disease. Although there are some randomised controlled clinical trials that prove the effect of ultrasound treatment on pain and functionality in the knee osteoarthritis, there is no study that proves the effect of ultrasound treatment on cartilage thickness and synovial fluid amount. The aim of this study is evaluating the effect of pulsed ultrasound treatment on cartilage regeneration, inflammation and quality of life in the volunteers diagnosed knee osteoarthritis. This study is unique because it is the first study that evaluates the effect of therapeutic pulsed ultrasound on synovial fluid and cartilage thickness with ultrasonography.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

About this study

The study is a randomised, controlled and parallel group study. 96 patients will be included to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of knee pain, aged between 45-75 years. Patients also have diagnosed as knee osteoarthritis according to American College of Rheumatology (ACR) diagnostic criteria and Kellgren-Lawrence grades are ≤3. These patients will be divided into two groups randomly (Treatment group n:48, control group n:48). The patients in the treatment group will receive treatment with 1 MHz probe with the intensity of 1w/cm2, pulsed at a ratio of 1:4 for 10 minutes and at an interval of 3 sessions per week for 8 weeks, a total of 24 sessions. On the other hand, sham US will be applied to control group for the same times and periods as the treatment group. A home exercise program will be given to both of two groups which contain knee range of motion and isometric strengthening exercises. The patients will be allowed to take paracetamol only when they complain of pain. All patients will be evaluated for 3 times, before and after treatment and 3 months after the treatment with ultrasonographic measurements and life quality tests. Primary aim of this study is to evaluate the effect of pulsed ultrasound on amount of synovial fluid and cartilage thickness.

For this purpose, cartilage thickness and reduction in the amount of synovial fluid will be measured via ultrasound.

Secondary aim is evaluating the effect of pulsed ultrasound on quality of life. Knee pain will be measured by VAS (Visual analogue scale) and functionality will be measured by WOMAC survey and Timed Up and Go Test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complain of knee pain
  • Aged between 45-75 years
  • Diagnosed as knee osteoarthritis according to American College of Rheumatology (ACR) diagnostic criteria and Kellgren-Lawrence grades are ≤3

Exclusion criteria

  • Infection
  • Arthritis
  • Using corticosteroids
  • Corticosteroid injections
  • Neurological deficit
  • History of knee surgery
  • Central and peripheral nerve diseases
  • Pregnancy
  • Malignancy

Treatment and study plan

Pulsed Ultrasound Treatment

Other

Patients will receive treatment with 1 MHz probe with the intensity of 1w/cm2, pulsed at a ratio of 1:4 for 10 minutes and at an interval of 3 sessions per week during 8 weeks, a total of 24 sessions.

Control Group

Other

Sham US will be applied to control group for the same times and periods as treatment group. A home exercise program will be given to both of two groups which contains knee range of motion and isometric strengthening exercises.

Primary outcomes

  1. Amount of synovial fluid

    Time frame: Change from Baseline Amount of synovial fluid at 12 weeks

    The amount of synovial fluid will be measured via ultrasonography in knee

Secondary outcomes

  1. Knee Pain: VAS

    Time frame: All patients will be evaluated for 3 times, at baseline and week 8 and week 12.

    Knee pain will be assessed with Visual Analog Scale (VAS 0-10 cm). Higher values will consider to be worse outcome.

  2. Function

    Time frame: All patients will be evaluated for 3 times at baseline and week 8 and week 12

    Functionally will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) . WOMAC subscores for pain, joint stiffness and daily living activities were calculated separately with likert scale (1 (best) -5 (worst)). Higher values will consider to be worse outcome.

  3. time up and go

    Time frame: All patients will be evaluated for 3 times at baseline and week 8 and week 12

    Functionally will be assessed with time up and go. 3 meters. The patient starts in a seated position.The patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down.The time stops when the patient is seated.Higher values will consider to be worse outcome

  4. cartilage thickness in knee

    Time frame: All patients will be evaluated for 3 times at baseline and week 8 and week 12

    cartilage thickness will be measured via ultrasonography in knee

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Assessing the Effects of Pulsed Ultrasound Treatment on Pain, Functionality, Synovial Fluid and Cartilage Thickness, in Knee Osteoarthritis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.