Is Pulsed Ultrasound Treatment Effective in Knee Osteoarthritis

NCT03705039 | Completed

• 1 other identifier: DorkuzEUAli
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; ultrasonography; ultrasound treatment

Outcome Measures

Primary Outcomes (1)

• Amount of synovial fluid

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

  Change from Baseline Amount of synovial fluid at 12 weeks

Secondary Outcomes (4)

• Knee Pain: VAS

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

• Function

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

• time up and go

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

• cartilage thickness in knee

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

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

pulsed ultrasound treatment

Other: Pulsed Ultrasound Treatment

Control Group

PLACEBO COMPARATOR

sham ultrasound treatment

Other: Control group

Interventions

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.

Treatment Group

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.

Control Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Banu Dilek, MD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: randomized controlled study

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 15, 2018
• Study Start: September 15, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)