NCT01535001

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

Completed NA Results posted Last updated 14 September 2017

What this trial tests

NA trial testing Neuromuscular training (NEMEX-TJR) in Osteoarthritis of the Knee in 100 participants. Completed in 1 September 2014.

Timeline

1 February 2012

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Northern Orthopaedic Division, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 February 2012
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	3 locations across Denmark

Drugs / interventions tested

• Neuromuscular training (NEMEX-TJR)
• Information
• Paracetamol (Paracetamol) — full drug profile →
• Burana — full drug profile →
• Pantoprazole (pantoprazole) — full drug profile →
• Dietary counseling
• Patient education — full drug profile →
• Insoles

Conditions studied

• Osteoarthritis of the Knee — all drugs for Osteoarthritis of the Knee →

Sponsor

Northern Orthopaedic Division, Denmark — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)
  Time frame: Primary: 12months.
  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 analysi

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Total knee replacement and non-surgical treatment of knee osteoarthritis: 2-year outcome from two parallel randomized controlled trials.
   Skou ST, Roos EM, Laursen MB, Rathleff MS, et al · · 2018 · cited 123× · PMID 29723634 · DOI 10.1016/j.joca.2018.04.014
2. 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.
   Skou ST, Rasmussen S, Laursen MB, Rathleff MS, et al · · 2015 · cited 60× · PMID 25937024 · DOI 10.1016/j.joca.2015.04.021
3. 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.
   Skou ST, Roos EM, Simonsen O, Laursen MB, et al · · 2016 · cited 23× · PMID 26241775 · DOI 10.1016/j.joca.2015.07.013
4. 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.
   Skou ST, Roos EM, Laursen MB, Rathleff MS, et al · · 2012 · cited 16× · PMID 23151395 · DOI 10.1136/bmjopen-2012-002168
5. 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.
   Skou ST, Roos EM, Laursen M, Arendt-Nielsen L, et al · · 2020 · cited 15× · PMID 32243994 · DOI 10.1016/j.joca.2020.03.009
6. Knee Confidence as It Relates to Self-reported and Objective Correlates of Knee Osteoarthritis: A Cross-sectional Study of 220 Patients.
   Skou ST, Rasmussen S, Simonsen O, Roos EM. · · 2015 · cited 12× · PMID 26304646 · DOI 10.2519/jospt.2015.5864
7. Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial.
   Larsen JB, Roos EM, Laursen M, Holden S, et al · · 2022 · cited 8× · PMID 36428014 · DOI 10.1136/bmjopen-2021-060169