STABILO: a randomised controlled trial of knee joint stabilisation therapy in osteoarthritis of the knee

Recruiting

• Conditions: arthrosis; 10023213; osteoarthritis

• Registration Number: NL-OMON33836
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

All potential participants* eligibility will first be assessed by a physiatrist, using the following inclusion criteria:
- diagnosis of knee OA according to the clinical ACR criteria, i.e.: knee pain and at least three of the following six: age > 50 years, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement and no palpable warmth.
- Age between 40 and 75 years
- Sufficient control of the Dutch language;Patients meeting these initial inclusion criteria will then be screened for symptoms of knee joint instability by a physical therapist. Patients are eligible for inclusion in the trial if they meet at least one of the following three criteria:
1. self-reported instability of the knee joint affecting daily functioning, as assessed with Irrgang*s knee stability questionnaire. A self-reported knee instability rating of 1 (*the symptom affects my activity slightly*) or worse is regarded to reflect knee instability affecting daily functioning
2. bodyweight-adjusted isokinetic quadriceps strength of 0.8 Nm/kg or less for men or 0.55 Nm/kg or less for women, in combination with a knee joint proprioception score of 4.3° or higher, as established with the instrumented knee proprioception test (9;28)
3. bodyweight-adjusted isokinetic quadriceps strength of 0.8 Nm/kg or less for men or 0.55 Nm/kg or less for women, in combination with a knee joint laxity score of 4.6° or higher for men or 7.7° or higher for women, as established with the instrumented knee laxity test (8;27)}

Exclusion Criteria

Co-morbidity which affects functional ability

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure in this RCT is self-reported physical functioning<br /><br>as assessed with the Western Ontario and McMaster Universities Osteoarthritis<br /><br>Index (WOMAC). The WOMAC-pf is a commonly used questionnaire to assess the<br /><br>physical functioning of patients with OA, and has been shown to be reliable,<br /><br>valid and sensitive to change.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A number of secondary outcome measures are included in the study, reflecting<br /><br>both the assessment of disabilities in specific daily activities, the patient<br /><br>perspective, and relevant biomechanical factors. These measures are: perceived<br /><br>global effect (7-point Likert scale), pain intensity (0-10 NRS), stiffness<br /><br>(WOMAC), fatigue (0-10 NRS), Irrgang*s and Felson*s self-reported knee joint<br /><br>instability scales, questionnaires on rising and sitting down, walking and<br /><br>stair climbing, proprioception, laxity, isokinetic muscle strength of the upper<br /><br>leg (BioDex) and frontal plane alignment of the knee (goniometer). Body length<br /><br>and weight will be collected at all time points to assess changes in Body Mass<br /><br>Index</p><br>