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Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis

NCT04197284 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-04-28

No results posted yet for this study

Summary

Osteoarthritis (OA) is a chronic joint disease that involves the entire joint, causing cartilage damage, bone remodeling, osteophyte formation and loss of normal joint function. Knee OA is one of the leading causes of disability in the world and thus represents a major public health problem. Knee OA treatment can be operative and non-operative. Non-operative treatment includes pharmacological treatment, changing life style and physical therapy. The goal of physical therapy in knee OA is to reduce pain and improve knee function through therapeutic exercise, especially by strengthening the quadriceps muscle. In addition to therapeutic exercise, muscle electrical stimulation is often used, and in the literature there is evidence of biofeedback therapy efficacy.

Goal of the study is to investigate whether there is a difference in pain reduction, increase in quadriceps muscle strength, and improvement in knee function in patients who had only kinesitherapy, from those who underwent kinesitherapy and biofeedback, and in patients who received electrical stimulation of quadriceps muscle with kinesitherapy. 93 patients with knee OA according to ACR criteria and Kellgren and Lawrence radiological classification grades 1 and 2 will be included in study. Subjects will complete: Visually Analogous Pain Scale (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36), International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set, and quadriceps muscle strength will be measured by EMG biofeedback device.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Biofeedback, Myomed 632

Biofeedback is a mind-body technique that involves using visual or auditory feedback to gain control over involuntary bodily functions. Electrical stimulation is a technique used to elicit a muscle contraction using electrical impulses.

DEVICE

device for electrical stimulation, BTL 4000 Smart

Electrical stimulation is a technique used to elicit a muscle contraction using electrical impulses. Electrodes, controlled by a unit, are placed on the skin over a predetermined area. Electrical current is then sent from the unit to the electrodes and delivered into the muscle causing a contraction.

OTHER

kinesitherapy

isometric exercise of the quadriceps muscle

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    lead OTHER

Principal Investigators

  • Ivan Bojanić, Prof Phd · Universty of Zagreb, School of medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2021-10-31
Completion
2022-06-30

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197284 on ClinicalTrials.gov