Is Pulsed Ultrasound Treatment Effective in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Pulsed Ultrasound Treatment; Control group
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; ultrasonography; ultrasound treatment