Optimization of exerCise Therapy in patients with knee Osteoarthritis in a Primary care Setting (OCTOPuS-study)

Completed

Conditions: knee osteoarthritis
10023213

Registration Number: NL-OMON48786

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 408

Inclusion Criteria

- knee pain (NRS during walking * 2/10) persisting for at least 3 months, as
reason to visit the PT;
- clinical diagnosis of knee OA according to the criteria of the American
College of Rheumatology (ACR), assessed by the PT: presence of knee pain and at
least three of the following six items: age > 45 years, morning stiffness < 30
minutes, crepitations, bone sensitivity, bony enlargement of the joint margin,
no palpable warmth;
- providing informed consent.

Exclusion Criteria

- age < 40 or > 85 years;
- severe knee pain (i.e., NRS pain severity during walking * 9/10);
- physical or mental comorbidity severely affecting daily life and a
contraindication for the usage of exercise therapy;
- suspicion of chronic widespread pain (i.e., pain present for at least three
months in at least three joints including left and right side of the body,
above and below the waist and the axial skeleton);
- presence of total knee arthroplasty (TKA) or on waiting list for TKA;
- other reasons for knee pain than knee OA (e.g., rheumatoid arthritis, gout)
- received PT-treatment or intra-articular injections in past 6 months because
of knee pain;
- insufficient comprehension of Dutch language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Knee pain severity (NRS) and physical functioning (KOOS subscale daily living)<br /><br>will be primary outcome measures. Measurements will be performed at baseline,<br /><br>and 3 months (primary endpoint), 6 months and 12 months follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures includes global perceived effect (GPE), pain<br /><br>interference, fatigue, and knee instability (questionnaires), and upper leg<br /><br>muscle strength, body mass index (BMI), and waist circumference (physical<br /><br>tests). In addition, an economic evaluation (by patient-reported costs and<br /><br>quality-adjusted life years (QALYs)) and a process evaluation (by treatment<br /><br>registration forms) will be performed. Measurements will be performed at<br /><br>baseline, and 3 months (primary endpoint), 6 months (questionnaires only), 9<br /><br>months (cost questionnaires only) and 12 months follow-up.</p><br>