Structured Non-operative Treatment of Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official title:

Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535001
• Other study ID #: N-20110085
• Status: Completed
• Phase: N/A
• First received: February 9, 2012
• Last updated: September 14, 2017
• Start date: February 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2017
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• 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.

Behavioral:
• 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.

Drug:
• Paracetamol
1 g x 4/day
• Burana
400 mg x 3/day for three weeks
• Pantoprazole
20mg x 1/day for three weeks

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital	Aalborg
Denmark	Farsoe Hospital	Farsø
Denmark	Vendsyssel Hospital, Frederikshavn	Frederikshavn

Sponsors (3)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Association of Danish Physiotherapists, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Fortin PR, Penrod JR, Clarke AE, St-Pierre Y, Joseph L, Bélisle 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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcomes	Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.; Number of sites with pain in the previous 24 hours shaded on a region-divided body chart; Pain location and type assessed using the Knee Pain Map.; Maximum isometric muscle strength measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander).; Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II) at five sites at the knee and the m. tibialis anterior muscle and the m. extensor carpi radialis longus.; Postural balance assessed using an instrumented force platform (Good Balance), measuring the centre of pressure excursion.; Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.	Baseline, 3months, 6months, 12months and 24months
Primary	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	Change From Baseline in EQ-5D	Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under "Links").; Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best).	Primary: 12months.
Secondary	Change From Baseline in 20-meter Walk		Primary: 12months.
Secondary	Change in the Five KOOS Subscale Scores From Baseline	Range of all subscales are 0 to 100 (worst to best).	Primary: 12 months.
Secondary	Weight Change in kg From Baseline	Weight change in kg measured without shoes at the same time of day and on the same scale	Primary: 12months.
Secondary	Proportion of Users of Pain Medication	With possible answers being yes and no	Baseline and 12months.
Secondary	Number of Serious Adverse Events Reported at Index Knee	Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants.	Primary: 12months.
Secondary	Change From Baseline in Time From the Timed Up and Go		Primary: 12 months.

External Links

•   Link to the published statistical analysis plan