Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis
NCT ID: NCT04197284
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
93 participants
INTERVENTIONAL
2020-08-28
2022-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
In control group subjects will undergo individual kinesitherapy- isometric exercise for strengthening of the quadriceps muscle.
kinesitherapy
isometric exercise of the quadriceps muscle
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.
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.
kinesitherapy
isometric exercise of the quadriceps muscle
Electrical stimulation
Electrical stimulation group will receive electrical stimulation of the quadriceps muscle and they will also perform isometric exercise.
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.
kinesitherapy
isometric exercise of the quadriceps muscle
Interventions
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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 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.
kinesitherapy
isometric exercise of the quadriceps muscle
Eligibility Criteria
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Inclusion Criteria
* knee pain for 3 months
* knee osteoarthritis defined by American College of Rheumatology Criteria
Exclusion Criteria
* 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
55 Years
ALL
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
Responsible Party
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Silvija Mahnik
MD, Physical medicine and rehabilitation specialist
Principal Investigators
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Ivan Bojanić, Prof Phd
Role: STUDY_CHAIR
Universty of Zagreb, School of medicine
Locations
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University Hospital Centre Zagreb, Department of Orthopaedic Surgery
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Lucca 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.
Yilmaz 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.
Akkaya 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.
Raeissadat 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.
Cherian 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.
Giggins 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.
Durmus 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.
de 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.
de 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.
Zeng 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.
Lepley 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.
Eid 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.
Bellamy 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.
Grazio 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.
Maslic Sersic D, Vuletic G. Psychometric evaluation and establishing norms of Croatian SF-36 health survey: framework for subjective health research. Croat Med J. 2006 Feb;47(1):95-102.
Hurley MV, Scott DL. Improvements in quadriceps sensorimotor function and disability of patients with knee osteoarthritis following a clinically practicable exercise regime. Br J Rheumatol. 1998 Nov;37(11):1181-7. doi: 10.1093/rheumatology/37.11.1181.
Other Identifiers
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1505984
Identifier Type: -
Identifier Source: org_study_id
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