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

NCT04197284 | Unknown

• 1 other identifier: 1505984
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; knee; biofeedback; electrical stimulation; kinesitherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 months

Secondary Outcomes (24)

• Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).

  3 weeks

• Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).

  3 months

• Impact of biofeedback therapy on knee function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).

  6 months

• Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.

  3 weeks

• Impact of biofeedback therapy on muscle strength measured by EMG biofeedback device.

  3 months

Study Arms (3)

Control group

ACTIVE COMPARATOR

In control group subjects will undergo individual kinesitherapy- isometric exercise for strengthening of the quadriceps muscle.

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.

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.

Device: device for electrical stimulation, BTL 4000 Smart; Other: kinesitherapy

Interventions

Biofeedback, Myomed 632 DEVICE

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.

Biofeedback group

device for electrical stimulation, BTL 4000 Smart DEVICE

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.

Electrical stimulation

kinesitherapy OTHER

isometric exercise of the quadriceps muscle

Biofeedback group; Control group; Electrical stimulation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Hospital Centre Zagreb, Department of Orthopaedic Surgery

Zagreb, 10000, Croatia

RECRUITING

Related Publications (17)

• 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.

  PMID: 25642061 BACKGROUND

• 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.

  PMID: 6823470 BACKGROUND

• 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.

  PMID: 19693508 BACKGROUND

• 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.

  PMID: 21971752 BACKGROUND

• 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.

  PMID: 30519081 BACKGROUND

• 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.

  PMID: 26852638 BACKGROUND

• 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.

  PMID: 22324059 BACKGROUND

• 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.

  PMID: 16897119 BACKGROUND

• 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.

  PMID: 23337561 BACKGROUND

• 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.

  PMID: 26871692 BACKGROUND

• 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.

  PMID: 25497083 BACKGROUND

• 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.

  PMID: 22289696 BACKGROUND

• 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.

  PMID: 27149595 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 16489702 BACKGROUND

• 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.

  PMID: 9851266 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Biofeedback, Psychology; Electric Stimulation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Physical Stimulation; Investigative Techniques

Study Officials

• Ivan Bojanić, Prof Phd

  Universty of Zagreb, School of medicine

  STUDY CHAIR

Central Study Contacts

Silvija Mahnik, MD

CONTACT

+385 (0)1 2368 911; silvija.mahnik@gmail.com

Ana Aljinovic, MD, Phd

CONTACT

+385 (0)1 2368 911; ana.aljinovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Physical medicine and rehabilitation specialist

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: December 13, 2019
• Study Start: August 28, 2020
• Primary Completion: October 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CR (1)