Structured Non-operative Treatment of Knee Osteoarthritis

NCT01535001 | Completed Results

• 1 other identifier: N-20110085
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis. 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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee; Treatment Outcome; Time Factors; Rehabilitation; Combined Modality Therapy; Middle Aged; Aged; Aged, 80 and over; Male; Female; Humans; Analysis of Variance

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)

  The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.

  Primary: 12months.

Secondary Outcomes (7)

• Change From Baseline in EQ-5D

  Primary: 12months.

• Change From Baseline in 20-meter Walk

  Primary: 12months.

• Change in the Five KOOS Subscale Scores From Baseline

  Primary: 12 months.

• Weight Change in kg From Baseline

  Primary: 12months.

• Proportion of Users of Pain Medication

  Baseline and 12months.

Other Outcomes (1)

• Exploratory Outcomes

  Baseline, 3months, 6months, 12months and 24months

Study Arms (2)

MEDIC

ACTIVE COMPARATOR

Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.

Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazole; Behavioral: Dietary counseling; Behavioral: Patient education; Other: Insoles

Standard treatment

ACTIVE COMPARATOR

Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.

Behavioral: Information

Interventions

Neuromuscular training (NEMEX-TJR) OTHER

60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.

Also known as: No other

MEDIC

Information BEHAVIORAL

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.

Also known as: No other

Standard treatment

Paracetamol DRUG

1 g x 4/day

Also known as: No other

MEDIC

Burana DRUG

400 mg x 3/day for three weeks

Also known as: No other

MEDIC

Pantoprazole DRUG

20mg x 1/day for three weeks

Also known as: No other

MEDIC

Dietary counseling BEHAVIORAL

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.

Also known as: No other

MEDIC

Patient education BEHAVIORAL

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.

Also known as: No other

MEDIC

Insoles OTHER

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.

Also known as: No other

MEDIC

Eligibility Criteria

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

You may qualify if:

• Knee-OA detected by x-ray (Kellgren \& Lawrence grade 1 or greater)
• 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.

You may not qualify if:

• Prior TKA ipsilateral
• 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.

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead
• The Danish Rheumatism Association: collaborator
• Association of Danish Physiotherapists: collaborator

Study Sites (3)

Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital

Aalborg, 9000, Denmark

Location

Farsoe Hospital

Farsø, 9640, Denmark

Location

Vendsyssel Hospital, Frederikshavn

Frederikshavn, 9900, Denmark

Location

Related Publications (14)

• 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.

  PMID: 14644851 BACKGROUND

• 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.

  PMID: 20170770 BACKGROUND

• 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.

  PMID: 18279766 BACKGROUND

• 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.

  PMID: 12483739 BACKGROUND

• 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.

  PMID: 19968215 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25937024 BACKGROUND

• 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.

  PMID: 36428014 DERIVED

• 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.

  PMID: 32243994 DERIVED

• 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.

  PMID: 29723634 DERIVED

• 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.

  PMID: 29369450 DERIVED

• 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.

  PMID: 26304646 DERIVED

• 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.

  PMID: 26241775 DERIVED

• 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.

  PMID: 23151395 DERIVED

Related Links

• Link to the published statistical analysis plan

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acetaminophen; Pantoprazole; Nutrition Assessment; Patient Education as Topic; Foot Orthoses

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Søren T. Skou
• Organization: Aalborg University Hospital

sots@rn.dk

+4523708640

Study Officials

• Søren T. Skou, PhD-student

  Orthopaedic Research Unit, Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Ewa M. Roos, PhD

  Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark

  STUDY CHAIR

• Lars Arendt-Nielsen, Dr.Sci.Med.

  Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University

  STUDY CHAIR

• Mogens B. Laursen, PhD

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Sten Rasmussen, M.D.

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Michael S. Rathleff, PhD-student

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Ole H. Simonsen, Dr.Sci.Med.

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 17, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 16, 2017
• Results First Posted: January 27, 2016

Record last verified: 2017-09

Locations

DK (3)