Is Pulsed Ultrasound Treatment Effective in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulsed Ultrasound Treatment
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, ultrasonography, ultrasound treatment
Eligibility Criteria
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
Sites / Locations
- Dokuz Eylul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment Group
Control Group
Arm Description
pulsed ultrasound treatment
sham ultrasound treatment
Outcomes
Primary Outcome Measures
Amount of synovial fluid
The amount of synovial fluid will be measured via ultrasonography in knee
Secondary Outcome Measures
Knee Pain: VAS
Knee pain will be assessed with Visual Analog Scale (VAS 0-10 cm). Higher values will consider to be worse outcome.
Function
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.
time up and go
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
cartilage thickness in knee
cartilage thickness will be measured via ultrasonography in knee
Full Information
NCT ID
NCT03705039
First Posted
September 24, 2018
Last Updated
March 1, 2020
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT03705039
Brief Title
Is Pulsed Ultrasound Treatment Effective in Knee Osteoarthritis
Official Title
Assessing the Effects of Pulsed Ultrasound Treatment on Pain, Functionality, Synovial Fluid and Cartilage Thickness, in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, ultrasonography, ultrasound treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
pulsed ultrasound treatment
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
sham ultrasound treatment
Intervention Type
Other
Intervention Name(s)
Pulsed Ultrasound Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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 Outcome Measure Information:
Title
Amount of synovial fluid
Description
The amount of synovial fluid will be measured via ultrasonography in knee
Time Frame
Change from Baseline Amount of synovial fluid at 12 weeks
Secondary Outcome Measure Information:
Title
Knee Pain: VAS
Description
Knee pain will be assessed with Visual Analog Scale (VAS 0-10 cm). Higher values will consider to be worse outcome.
Time Frame
All patients will be evaluated for 3 times, at baseline and week 8 and week 12.
Title
Function
Description
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.
Time Frame
All patients will be evaluated for 3 times at baseline and week 8 and week 12
Title
time up and go
Description
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
Time Frame
All patients will be evaluated for 3 times at baseline and week 8 and week 12
Title
cartilage thickness in knee
Description
cartilage thickness will be measured via ultrasonography in knee
Time Frame
All patients will be evaluated for 3 times at baseline and week 8 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Dilek, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Is Pulsed Ultrasound Treatment Effective in Knee Osteoarthritis
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