Osteoarthritis, KneeBFBOANCT04197284
Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis
A study testing Biofeedback, Myomed 632, device for electrical stimulation, BTL 4000 Smart and kinesitherapy in people with Osteoarthritis, Knee, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Biofeedback, Myomed 632, device for electrical stimulation, BTL 4000 Smart and kinesitherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteCroatia
- Study dates
- 28 Aug 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- surgery on that knee
- pacemaker
- metallic foreign body in the area of stimulation
- thrombophlebitis and thrombosis
- skin infection
- malignancy,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Centre Zagreb, Department of Orthopaedic Surgery
Zagreb, 10000
Silvija Mahnik, MD, +385 (0)1 2368 911, silvija.mahnik@gmail.com
Ana Aljinović, Phd, +385 (0)1 2368 911, ana.aljinovic@gmail.com
About this study
Official title: Comparison of Efficacy of Biofeedback, Electrical Stimulation and Therapeutic Exercise in Patients With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Biofeedback, Myomed 632, device for electrical stimulation, BTL 4000 Smart, kinesitherapy
- Keywords
- osteoarthritis, knee, biofeedback, electrical stimulation, kinesitherapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback, Myomed 632Device
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 for electrical stimulation, BTL 4000 SmartDevice
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.
kinesitherapyOther
isometric exercise of the quadriceps muscle
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | In control group subjects will undergo individual kinesitherapy- isometric exercise for strengthening of the quadriceps muscle. Receives: Other: kinesitherapy |
| Biofeedback group | Active comparator | 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. Receives: Device: Biofeedback, Myomed 632; Other: kinesitherapy |
| Electrical stimulation | Active comparator | Electrical stimulation group will receive electrical stimulation of the quadriceps muscle and they will also perform isometric exercise. Receives: Device: device for electrical stimulation, BTL 4000 Smart; Other: kinesitherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 3 weeks
Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 3 months
Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 6 months
Secondary outcomes (24)
Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 3 weeks
Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 3 months
Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 6 months
Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.
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.
Measured: 3 weeks
Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.
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.
Measured: 3 months
Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.
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.
Measured: 6 months
Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 3 weeks
Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 3 months
Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 6 months
Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 3 weeks
Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 3 months
Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 6 months
Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.
Determine whether kinesitherapy for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.
Measured: 3 weeks
Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.
Determine whether kinesitherapy for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.
Measured: 3 months
Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.
Determine whether kinesitherapy for quadriceps muscle strengthening changes quadriceps muscle strength measured on EMG biofeedback device in micro volts during maximal voluntary isometric contraction.
Measured: 6 months
Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 3 weeks
Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 3 months
Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).
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.
Measured: 6 months
Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 3 weeks
Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 3 months
Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
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.
Measured: 6 months
Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.
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.
Measured: 3 weeks
Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.
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.
Measured: 3 months
Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start28 Aug 2020
- Primary completionOct 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvija Mahnik, Clinical Hospital Centre Zagreb
- Investigators
- Ivan Bojanić, Prof Phd, Study chair, Universty of Zagreb, School of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197284
- Sponsor's protocol ID
- 1505984
- Acronym
- BFBOA
- Status last verified
- Apr 2021
- First submitted
- 10 Nov 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choi YL, Kim BK, Hwang YP, Moon OK, Choi WS. Effects of isometric exercise using biofeedback on maximum voluntary isometric contraction, pain, and muscle thickness in patients with knee osteoarthritis. J Phys Ther Sci. 2015 Jan;27(1):149-53. doi: 10.1589/jpts.27.149. Epub 2015 Jan 9.
PubMed 25642061Lucca JA, Recchiuti SJ. Effect of electromyographic biofeedback on an isometric strengthening program. Phys Ther. 1983 Feb;63(2):200-3. doi: 10.1093/ptj/63.2.200.
PubMed 6823470Yilmaz OO, Senocak O, Sahin E, Baydar M, Gulbahar S, Bircan C, Alper S. Efficacy of EMG-biofeedback in knee osteoarthritis. Rheumatol Int. 2010 May;30(7):887-92. doi: 10.1007/s00296-009-1070-9. Epub 2009 Aug 20.
PubMed 19693508Akkaya N, Ardic F, Ozgen M, Akkaya S, Sahin F, Kilic A. Efficacy of electromyographic biofeedback and electrical stimulation following arthroscopic partial meniscectomy: a randomized controlled trial. Clin Rehabil. 2012 Mar;26(3):224-36. doi: 10.1177/0269215511419382. Epub 2011 Oct 4.
PubMed 21971752Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, Mollayi F. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. J Pain Res. 2018 Nov 8;11:2781-2789. doi: 10.2147/JPR.S169613. eCollection 2018.
PubMed 30519081Cherian JJ, McElroy MJ, Kapadia BH, Bhave A, Mont MA. Prospective Case Series of NMES for Quadriceps Weakness and Decrease Function in Patients with Osteoarthritis of the Knee. J Long Term Eff Med Implants. 2015;25(4):301-6. doi: 10.1615/jlongtermeffmedimplants.2015012620.
PubMed 26852638Giggins O, Fullen B, Coughlan G. Neuromuscular electrical stimulation in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Clin Rehabil. 2012 Oct;26(10):867-81. doi: 10.1177/0269215511431902. Epub 2012 Feb 9.
PubMed 22324059Durmus D, Alayli G, Canturk F. Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis. Clin Rheumatol. 2007 May;26(5):674-8. doi: 10.1007/s10067-006-0358-3. Epub 2006 Aug 1.
PubMed 16897119de Oliveira Melo M, Aragao FA, Vaz MA. Neuromuscular electrical stimulation for muscle strengthening in elderly with knee osteoarthritis - a systematic review. Complement Ther Clin Pract. 2013 Feb;19(1):27-31. doi: 10.1016/j.ctcp.2012.09.002. Epub 2012 Oct 18.
PubMed 23337561de Oliveira Melo M, Pompeo KD, Baroni BM, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on neuromuscular parameters and health status in elderly women with knee osteoarthritis: A randomized trial. J Rehabil Med. 2016 Mar;48(3):293-9. doi: 10.2340/16501977-2062.
PubMed 26871692Zeng C, Li H, Yang T, Deng ZH, Yang Y, Zhang Y, Lei GH. Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage. 2015 Feb;23(2):189-202. doi: 10.1016/j.joca.2014.11.014. Epub 2014 Nov 26.
PubMed 25497083Lepley AS, Gribble PA, Pietrosimone BG. Effects of electromyographic biofeedback on quadriceps strength: a systematic review. J Strength Cond Res. 2012 Mar;26(3):873-82. doi: 10.1519/JSC.0b013e318225ff75.
PubMed 22289696Eid MA, Aly SM, El-Shamy SM. Effect of Electromyographic Biofeedback Training on Pain, Quadriceps Muscle Strength, and Functional Ability in Juvenile Rheumatoid Arthritis. Am J Phys Med Rehabil. 2016 Dec;95(12):921-930. doi: 10.1097/PHM.0000000000000524.
PubMed 27149595Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
PubMed 3068365Grazio S. [International Classification of Functioning, Disability and Health (ICF) in the most important diseases and conditions of rheumatology practice]. Reumatizam. 2011;58(1):27-43. Croatian.
PubMed 21751573
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Biofeedback, Electrical Stimulation and Therapeutic Exercise in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04197284
- Acronym / sponsor ID
- BFBOA / 1505984
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, biofeedback, electrical stimulation, kinesitherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: kinesitherapyIn control group subjects will undergo individual kinesitherapy- isometric exercise for strengthening of the quadriceps muscle. |
| Biofeedback group | Active comparator | Device: Biofeedback, Myomed 632, Other: kinesitherapyBiofeedback 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. |
| Electrical stimulation | Active comparator | Device: device for electrical stimulation, BTL 4000 Smart, Other: kinesitherapyElectrical stimulation group will receive electrical stimulation of the quadriceps muscle and they will also perform isometric exercise. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- surgery on that knee
- pacemaker
- metallic foreign body in the area of stimulation
- thrombophlebitis and thrombosis
- skin infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback, Myomed 632Biofeedback 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 | Biofeedback group |
| device for electrical stimulation, BTL 4000 SmartElectrical 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. | Device | Electrical stimulation |
| kinesitherapyisometric exercise of the quadriceps muscle | Other | Biofeedback group, Control group, Electrical stimulation |
Primary outcome
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.
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.
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.
24 secondary outcomes
Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 3 weeks
Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 3 months
Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 6 months
Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.
Time frame: 3 weeks
Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.
Time frame: 3 months
Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.
Time frame: 6 months
Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).
Time frame: 3 weeks
Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).
Time frame: 3 months
Impact of kinesitherapy on knee pain measured on Visual Analogue Scale (VAS).
Time frame: 6 months
Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 3 weeks
Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 3 months
Impact of kinesitherpay on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 6 months
Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.
Time frame: 3 weeks
Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.
Time frame: 3 months
Impact of kinesiotherapy on quadriceps muscle strength measured by EMG biofeedback device.
Time frame: 6 months
Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).
Time frame: 3 weeks
Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).
Time frame: 3 months
Impact of electrical stimulation of the quadriceps muscle on knee pain measured on Visual Analogue Scale (VAS).
Time frame: 6 months
Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 3 weeks
Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 3 months
Impact of electrical stimulation on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 6 months
Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.
Time frame: 3 weeks
Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.
Time frame: 3 months
Impact of electrical stimulation on quadriceps muscle strength measured by EMG biofeedback device.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 25642061Choi YL, Kim BK, Hwang YP, Moon OK, Choi WS. Effects of isometric exercise using biofeedback on maximum voluntary isometric contraction, pain, and muscle thickness in patients with knee osteoarthritis. J Phys Ther Sci. 2015 Jan;27(1):149-53. doi: 10.1589/jpts.27.149. Epub 2015 Jan 9.
- Background: PubMed 6823470Lucca JA, Recchiuti SJ. Effect of electromyographic biofeedback on an isometric strengthening program. Phys Ther. 1983 Feb;63(2):200-3. doi: 10.1093/ptj/63.2.200.
- Background: PubMed 19693508Yilmaz OO, Senocak O, Sahin E, Baydar M, Gulbahar S, Bircan C, Alper S. Efficacy of EMG-biofeedback in knee osteoarthritis. Rheumatol Int. 2010 May;30(7):887-92. doi: 10.1007/s00296-009-1070-9. Epub 2009 Aug 20.
- Background: PubMed 21971752Akkaya N, Ardic F, Ozgen M, Akkaya S, Sahin F, Kilic A. Efficacy of electromyographic biofeedback and electrical stimulation following arthroscopic partial meniscectomy: a randomized controlled trial. Clin Rehabil. 2012 Mar;26(3):224-36. doi: 10.1177/0269215511419382. Epub 2011 Oct 4.
- Background: PubMed 30519081Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, Mollayi F. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. J Pain Res. 2018 Nov 8;11:2781-2789. doi: 10.2147/JPR.S169613. eCollection 2018.
- Background: PubMed 26852638Cherian JJ, McElroy MJ, Kapadia BH, Bhave A, Mont MA. Prospective Case Series of NMES for Quadriceps Weakness and Decrease Function in Patients with Osteoarthritis of the Knee. J Long Term Eff Med Implants. 2015;25(4):301-6. doi: 10.1615/jlongtermeffmedimplants.2015012620.
- Background: PubMed 22324059Giggins O, Fullen B, Coughlan G. Neuromuscular electrical stimulation in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Clin Rehabil. 2012 Oct;26(10):867-81. doi: 10.1177/0269215511431902. Epub 2012 Feb 9.
- Background: PubMed 16897119Durmus D, Alayli G, Canturk F. Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis. Clin Rheumatol. 2007 May;26(5):674-8. doi: 10.1007/s10067-006-0358-3. Epub 2006 Aug 1.
- Background: PubMed 23337561de Oliveira Melo M, Aragao FA, Vaz MA. Neuromuscular electrical stimulation for muscle strengthening in elderly with knee osteoarthritis - a systematic review. Complement Ther Clin Pract. 2013 Feb;19(1):27-31. doi: 10.1016/j.ctcp.2012.09.002. Epub 2012 Oct 18.
- Background: PubMed 26871692de Oliveira Melo M, Pompeo KD, Baroni BM, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on neuromuscular parameters and health status in elderly women with knee osteoarthritis: A randomized trial. J Rehabil Med. 2016 Mar;48(3):293-9. doi: 10.2340/16501977-2062.
- Background: PubMed 25497083Zeng C, Li H, Yang T, Deng ZH, Yang Y, Zhang Y, Lei GH. Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage. 2015 Feb;23(2):189-202. doi: 10.1016/j.joca.2014.11.014. Epub 2014 Nov 26.
- Background: PubMed 22289696Lepley AS, Gribble PA, Pietrosimone BG. Effects of electromyographic biofeedback on quadriceps strength: a systematic review. J Strength Cond Res. 2012 Mar;26(3):873-82. doi: 10.1519/JSC.0b013e318225ff75.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Bojanić, Prof Phd study chair
Universty of Zagreb, School of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback, Myomed 632, device for electrical stimulation, BTL 4000 Smart and kinesitherapy in people with Osteoarthritis, Knee, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvija Mahnik, MD (+385 (0)1 2368 911, silvija.mahnik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of biofeedback therapy on change in knee pain measured on Visual Analogue Scale (VAS). (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197284, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.