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Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis (BFBOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197284
Recruitment Status : Suspended (Study has been postponed due to situation with corona virus and our clinic suffered sever damage after strong earthquake 22.3.2020.)
First Posted : December 13, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Silvija Mahnik, Clinical Hospital Centre Zagreb

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Biofeedback, Myomed 632 Device: device for electrical stimulation, BTL 4000 Smart Other: kinesitherapy Not Applicable

Detailed Description:

The research will be conducted in the Department of Orthopedic surgery of the Clinical Hospital Center Zagreb. The research will be prospective, randomized, single blinded. Randomization of patients will be performed before physical therapy using web site www.randomization.com, and the results of the randomization will be known to the physician who will not be directly involved in the treatment or examination of patients.

All patients will sign informed consent before the study begins. Research has been approved by the Ethics Committee of Clinical Hospital Center Zagreb and Ethics committee of the School of Medicine, University of Zagreb.

Inclusion criteria are: patients age 55 years and older who have knee OA according to the American College of Rheumatology criteria (ACR) and knee OA according to Kellgren and Lawrence Radiology Classification Grade 1 and 2, and who report knee pain for at least 3 months. Exclusion criteria are: patients who had surgery on that knee, patients with a pacemaker, and metallic foreign body in the area of muscle stimulation, patients with thrombophlebitis and deep vein thrombosis, patients with skin infection, malignancy, bleeding disorders, patients with neurological disease, patients with inflammatory rheumatological disease, with congenital and acquired knee deformities, with contractures of the hips and ankles, with grade 3 and 4 osteoarthritis according to Kellgren and Lawrence classification, patients who received intraarticular knee injection in the last 3 months and patients with post-traumatic knee osteoarthritis and osteonecrosis.

The investigators will record: age, sex, height, weight, body mass index, leg length and use of orthopedics aids. Clinical examination will be performed on the first day, day 21, after 90 and after 180 days.

At each examination patients will complete following questionnaires: Visually Analog Scale for pain (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36) and International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set.

Quadriceps muscle strength will be measured with a Biofeedback therapy device (EMG Biofeedback, Myomed 632, United Kingdom, 2017) .

Patients will be randomisen in three groups. Patients in the first group will be treated with individual kinesitherapy. Patients in the second group will be treated with individual kinesitherapy and biofeedback therapy for strengthening of the quadriceps muscle using EMG Biofeedback device, Myomed 632, United Kingdom, 2017.

Patients in the third group will be treated with individual kinesitherapy together with electrical stimulation of the quadriceps muscle using electrostimulation device (BTL- 4000 Smart, United Kingdom, 2017).

The required sample size was calculated based on pain values data reported in the study by Choi et al. Pain was measured using VAS scale, and sample size was calculated using G Power software package (v3.1.9.4). With the parameter of statistical significance level (alpha) of 0.05 and a test power (1 - beta) of 0.90, based on the data from the Choi et al work, the required final sample size is a total of 93 subjects and 31 subjects for each of the three groups.

The investigators expect to find that kinesitherapy and biofeedback therapy are more efficient compared to kinesitherapy alone or and kinesitherapy and electrical stimulation in reducing pain, improving knee function and strengthening of the quadriceps muscle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The research will be single-blind. Randomization of patients will be performed immediately prior to physical therapy using web page www.randomization.com, and the results of the randomization will be known to the physician who will not be directly involved in the treatment or examination of patients.
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Biofeedback, Electrical Stimulation and Therapeutic Exercise in Patients With Knee Osteoarthritis
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Control group
In control group subjects will undergo individual kinesitherapy- isometric exercise for strengthening of the quadriceps muscle.
Other: kinesitherapy
isometric exercise of the quadriceps muscle

Active Comparator: Biofeedback group
Biofeedback group will perform physical therapy using biofeedback device for better activation control of the quadriceps muscle with audio and visual signal. They will also perform isometric exercise.
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.


Other: kinesitherapy
isometric exercise of the quadriceps muscle

Active Comparator: Electrical stimulation
Electrical stimulation group will receive electrical stimulation of the quadriceps muscle and they will also perform isometric exercise.
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




Primary Outcome Measures :
  1. Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 3 weeks ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening will change knee pain score measured on Visual Analogue Scale (VAS). Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  2. Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 3 months ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening will change knee pain score measured on Visual Analogue Scale (VAS). Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  3. Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 6 months ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening will change knee pain score measured on Visual Analogue Scale (VAS). Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.


Secondary Outcome Measures :
  1. Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 weeks ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  2. Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 months ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  3. Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 6 months ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  4. Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device. [ Time Frame: 3 weeks ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  5. Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device. [ Time Frame: 3 months ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  6. Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device. [ Time Frame: 6 months ]
    Determine whether the use of biofeedback for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  7. Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 3 weeks ]
    Determine whether kinesitherapy for quadriceps muscle strengthening will change knee pain score measured on VAS scale. Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  8. Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 3 months ]
    Determine whether kinesitherapy for quadriceps muscle strengthening will change knee pain score measured on VAS scale. Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  9. Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 6 months ]
    Determine whether kinesitherapy for quadriceps muscle strengthening will change knee pain score measured on VAS scale. Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  10. Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 weeks ]
    Determine whether kinesitherapy for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  11. Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 months ]
    Determine whether kinesitherapy for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  12. Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 6 months ]
    Determine whether kinesitherapy for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  13. Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device. [ Time Frame: 3 weeks ]
    Determine whether kinesitherapy for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  14. Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device. [ Time Frame: 3 months ]
    Determine whether kinesitherapy for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  15. Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device. [ Time Frame: 6 months ]
    Determine whether kinesitherapy for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  16. Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 3 weeks ]
    Determine whether electrical stimulation for quadriceps muscle strengthening will change knee pain score measured on VAS scale. Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  17. Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 3 months ]
    Determine whether electrical stimulation for quadriceps muscle strengthening will change knee pain score measured on VAS scale. Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  18. Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS). [ Time Frame: 6 months ]
    Determine whether electrical stimulation for quadriceps muscle strengthening will change knee pain score measured on VAS scale. Change will be measured on VAS scale in millimeters, from 0 to 100 mm, a higher score indicates greater pain intensity.

  19. Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 weeks ]
    Determine whether the use of electrical stimulation for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  20. Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 3 months ]
    Determine whether the use of electrical stimulation for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  21. Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC). [ Time Frame: 6 months ]
    Determine whether the use of electrical stimulation for quadriceps muscle strengthening changes knee function score measured by WOMAC questionnaire. Questionnaire consists 24 items divided into 3 subscales: Pain, Stifness and Physical Functioning. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.The test questions are scored on a scale of 0-4 , from best to worse. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  22. Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device. [ Time Frame: 3 weeks ]
    Determine whether the use of electrical stimulation for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  23. Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device. [ Time Frame: 3 months ]
    Determine whether the use of electrical stimulation for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.

  24. Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device. [ Time Frame: 6 months ]
    Determine whether the use of electrical stimulation for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • radiological evidence of primary OA with Grade 1 and 2 on the Kellgren-Lawrence Scale
  • knee pain for 3 months
  • knee osteoarthritis defined by American College of Rheumatology Criteria

Exclusion Criteria:

  • surgery on that knee
  • pacemaker
  • metallic foreign body in the area of stimulation
  • thrombophlebitis and thrombosis
  • skin infection
  • malignancy,
  • bleeding disorders
  • neurological disease
  • inflammatory rheumatology disease
  • congenital and acquired knee deformities
  • contracture of the hips and ankles
  • grade 3 and 4 osteoarthritis om the Kellgren and Lawrence classification
  • intraarticular injection in the last 3 months
  • post-traumatic knee osteoarthritis and osteonecrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197284


Locations
Layout table for location information
Croatia
University Hospital Centre Zagreb, Department of Orthopaedic Surgery
Zagreb, Croatia, 10000
Sponsors and Collaborators
Clinical Hospital Centre Zagreb
Investigators
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Study Chair: Ivan Bojanić, Prof Phd Universty of Zagreb, School of medicine
Publications:

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Responsible Party: Silvija Mahnik, MD, Physical medicine and rehabilitation specialist, Clinical Hospital Centre Zagreb
ClinicalTrials.gov Identifier: NCT04197284    
Other Study ID Numbers: 1505984
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvija Mahnik, Clinical Hospital Centre Zagreb:
osteoarthritis
knee
biofeedback
electrical stimulation
kinesitherapy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases