r-ESWT in Moderate Knee Osteoarthritis

Mustafa Kemal University

Status: Completed

Conditions: Orthopedic Disorder

Treatments: Device: ESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT04243135

Protocol Code: 2017/166

Details and patient eligibility

About

This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis.

Full description

Extracorporeal shock wave therapy (ESWT) has been increasingly used to help relieve pain and to remedy musculoskeletal disorders in recent years. ESWT seems to be an effective treatment modality many different musculoskeletal conditions, including rotator cuff tendinopathies, calcifying tendinopathy of the shoulder, lateral epicondylitis, greater trochanteric pain syndrome, patellar tendinopathy, achilles tendinopathy, plantar fasciitis, and bone disorders. ESWT seems to have chondroprotective, anti-inflammatory, neovascularization, anti-apoptotic, and tissue regeneration effect on tissues which could be relevant in the treatment of OA.

Enrollment: 110 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Knee OA according to American College of Rheumatology (ACR) diagnostic criteria with Kellgren - Lawrence (K-L) grade 2 or 3.

Exclusion criteria

• Patients with secondary OA,
• severe chronic illness,
• poor general health status (heart failure, chronic bronchitis, etc.),
• chronic inflammatory diseases,
• knee replacement surgery,
• prior malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

ESWT group

Active Comparator group

Description:

All patients in both groups were applied with a hot pack for 40-minutes, transcutaneous electrical nerve stimulation for 30-minutes (100 Hz frequency and 60 milliseconds pulse duration), and a home-based exercise program around the knee for 30-minutes per day for three weeks. Also, each patient in group 1 received shockwaves of continuous frequency and intensity (2000 shocks, 10 Hz, 2.0 to 3.0 bar), while the second group of patients received sham-ESWT. In group 1, for a total of 3 weeks, r-ESWT was undertaken with 2000 pulse each time at a week interval totaling 6000 pulse by using a radial shock wave therapy system (vibrolith ortho tip ESWT (ELMED Turkey)).

Treatment:

Device: ESWT

Sham-ESWT group

Sham Comparator group

Description:

The other group received sham-ESWT at 0.1 bar in the same area. The patients were placed supine with the affected knee at 90 degrees flexion at each treatment session. The shock wave probe was held stationary on painful points around the knee or at the patellofemoral and tibiofemoral borders of the target knee.

Treatment:

Device: ESWT