Structured Non-operative Treatment of Knee Osteoarthritis
NCT ID: NCT01535001
Last Updated: 2017-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-02-29
2014-09-30
Brief Summary
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The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study.
Detailed Description
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It is recommended both nationally and internationally that the treatment of knee osteoarthritis should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement.
However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.
The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Neuromuscular training (NEMEX-TJR)
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol
1 g x 4/day
Burana
400 mg x 3/day for three weeks
Pantoprazole
20mg x 1/day for three weeks
Dietary counseling
For participants with a BMI equal to or \>25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.
Patient education
The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden.
Insoles
The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes.
Standard treatment
Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information
Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet.
Interventions
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Neuromuscular training (NEMEX-TJR)
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Information
Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Information will be given in a leaflet.
Paracetamol
1 g x 4/day
Burana
400 mg x 3/day for three weeks
Pantoprazole
20mg x 1/day for three weeks
Dietary counseling
For participants with a BMI equal to or \>25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.
Patient education
The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden.
Insoles
The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
The participants will be advised to use the insoles in all shoes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* KOOS4 of ≤ 75
* Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
* The participant is \> 18 years of age.
* The participant can provide relevant and adequate, informed consent.
Exclusion Criteria
* Rheumatoid arthritis
* Mean VAS \> 60mm the last week on a 0-100mm scale
* Possible pregnancy or planning pregnancy;
* Inability to comply with the protocol;
* Inadequacy in written and spoken Danish.
18 Years
ALL
No
Sponsors
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The Danish Rheumatism Association
OTHER
Association of Danish Physiotherapists
OTHER
Northern Orthopaedic Division, Denmark
OTHER
Responsible Party
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Principal Investigators
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Søren T. Skou, PhD-student
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Ewa M. Roos, PhD
Role: STUDY_CHAIR
Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
Lars Arendt-Nielsen, Dr.Sci.Med.
Role: STUDY_CHAIR
Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University
Mogens B. Laursen, PhD
Role: STUDY_CHAIR
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Sten Rasmussen, M.D.
Role: STUDY_CHAIR
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Michael S. Rathleff, PhD-student
Role: STUDY_CHAIR
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Ole H. Simonsen, Dr.Sci.Med.
Role: STUDY_CHAIR
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Locations
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Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital
Aalborg, , Denmark
Farsoe Hospital
Farsø, , Denmark
Vendsyssel Hospital, Frederikshavn
Frederikshavn, , Denmark
Countries
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References
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Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
Fortin PR, Penrod JR, Clarke AE, St-Pierre Y, Joseph L, Belisle P, Liang MH, Ferland D, Phillips CB, Mahomed N, Tanzer M, Sledge C, Fossel AH, Katz JN. Timing of total joint replacement affects clinical outcomes among patients with osteoarthritis of the hip or knee. Arthritis Rheum. 2002 Dec;46(12):3327-30. doi: 10.1002/art.10631.
Rossi MD, Eberle T, Roche M, Waggoner M, Blake R, Burwell B, Baxter A. Delaying knee replacement and implications on early postoperative outcomes: a pilot study. Orthopedics. 2009 Dec;32(12):885. doi: 10.3928/01477447-20091020-06.
National Board of Health, Denmark. Referenceprogram for knæartrose. Copenhagen: National Board of Health, Denmark; 2007. [22.02.2010] found at: http://www.sst.dk/publ/Publ2007/PLAN/SfR/Refprg_knaeartrose.pdf
Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Roos EM. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage. 2015 Sep;23(9):1465-75. doi: 10.1016/j.joca.2015.04.021. Epub 2015 Apr 30.
Larsen JB, Roos EM, Laursen M, Holden S, Johansen MN, Rathleff MS, Arendt-Nielsen L, Rasmussen S, Skou ST. Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial. BMJ Open. 2022 Nov 25;12(11):e060169. doi: 10.1136/bmjopen-2021-060169.
Skou ST, Roos EM, Laursen M, Arendt-Nielsen L, Rasmussen S, Simonsen O, Ibsen R, Larsen AT, Kjellberg J. Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial. Osteoarthritis Cartilage. 2020 Jul;28(7):907-916. doi: 10.1016/j.joca.2020.03.009. Epub 2020 Mar 31.
Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S, Simonsen O. Total knee replacement and non-surgical treatment of knee osteoarthritis: 2-year outcome from two parallel randomized controlled trials. Osteoarthritis Cartilage. 2018 Sep;26(9):1170-1180. doi: 10.1016/j.joca.2018.04.014. Epub 2018 May 1.
Arendt-Nielsen L, Simonsen O, Laursen MB, Roos EM, Rathleff MS, Rasmussen S, Skou ST. Pain and sensitization after total knee replacement or nonsurgical treatment in patients with knee osteoarthritis: Identifying potential predictors of outcome at 12 months. Eur J Pain. 2018 Jul;22(6):1088-1102. doi: 10.1002/ejp.1193. Epub 2018 Feb 15.
Skou ST, Rasmussen S, Simonsen O, Roos EM. Knee Confidence as It Relates to Self-reported and Objective Correlates of Knee Osteoarthritis: A Cross-sectional Study of 220 Patients. J Orthop Sports Phys Ther. 2015 Oct;45(10):765-71. doi: 10.2519/jospt.2015.5864. Epub 2015 Aug 24.
Skou ST, Roos EM, Simonsen O, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S. The efficacy of non-surgical treatment on pain and sensitization in patients with knee osteoarthritis: a pre-defined ancillary analysis from a randomized controlled trial. Osteoarthritis Cartilage. 2016 Jan;24(1):108-16. doi: 10.1016/j.joca.2015.07.013. Epub 2015 Aug 1.
Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. Efficacy of multimodal, systematic non-surgical treatment of knee osteoarthritis for patients not eligible for a total knee replacement: a study protocol of a randomised controlled trial. BMJ Open. 2012 Nov 14;2(6):e002168. doi: 10.1136/bmjopen-2012-002168. Print 2012.
Related Links
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Link to the published statistical analysis plan
Other Identifiers
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N-20110085
Identifier Type: -
Identifier Source: org_study_id