The present project aims to evaluate the effectiveness and cost-effectiveness of stratified exercise therapy, compared to usual care, in patients with knee OA treated by PTs in primary care.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Knee pain severity (NRS) and physical functioning (KOOS subscale daily living)
will be primary outcome measures. Measurements will be performed at baseline,
and 3 months (primary endpoint), 6 months and 12 months follow-up.
Secondary outcome
Secondary outcome measures includes global perceived effect (GPE), pain
interference, fatigue, and knee instability (questionnaires), and upper leg
muscle strength, body mass index (BMI), and waist circumference (physical
tests). In addition, an economic evaluation (by patient-reported costs and
quality-adjusted life years (QALYs)) and a process evaluation (by treatment
registration forms) will be performed. Measurements will be performed at
baseline, and 3 months (primary endpoint), 6 months (questionnaires only), 9
months (cost questionnaires only) and 12 months follow-up.
Background summary
Knee osteoarthritis (OA) is a highly heterogeneous disease, in which exercise
therapy by a physical therapist (PT) is recommended as a first-step,
conservative treatment. Nonetheless, the clinical effects of exercise therapy
are only modest, which may be attributed to a generic, *one-size-fits-all*
approach. Because of the large heterogeneity of knee OA with large differences
between patients, a stratified approach in exercise therapy, meaning that
patients are allocated to subgroups and receive a subgroup-specific
intervention, may be superior over usual exercise therapy. Recently, we were
able to identify clinically relevant subgroups of knee OA patients, developed a
model of stratified exercise therapy based on these subgroups, and tested its
feasibility in a pilot-study. Therefore, it is timely to evaluate the
effectiveness and cost-effectiveness of stratified exercise therapy compared to
usual (*non-stratified*) care by PTs in a large-scale cluster randomized
controlled trial (CRCT).
Study objective
The present project aims to evaluate the effectiveness and cost-effectiveness
of stratified exercise therapy, compared to usual care, in patients with knee
OA treated by PTs in primary care.
Study design
A pragmatic, cluster randomized controlled trial (CRCT) with an economic and a
process evaluation, comparing stratified exercise therapy with usual care by
PTs in primary care. Approximately 120 PTs from 60 PT practices in a primary
care setting (at least 2 participating PTs per practice) will be randomized on
the level of PT practice in a 1:2 ratio to provide the experimental
intervention (stratified exercise therapy for 204 patients; by 40 PTs/20
practices) or control intervention (usual care for 204 patients; by 80 PTs/40
practices), respectively.
Intervention
The model of stratified exercise therapy for PTs consists of a stratification
tool and subgroup-specific, protocolized exercise therapy. Based on the
stratification tool, patients will be allocated to a *high muscle strength
subgroup*, *low muscle strength subgroup*, or *obesity subgroup*. For the
*obesity subgroup*, a dietary treatment by a dietician in primary care will be
provided, in addition to the exercise therapy. The control intervention will be
usual care from the PT.
Study burden and risks
All patients (from both treatment arms) will be treated by their PT, with
clinical effects and minimal risks to be expected. In the pilot-study (n=50),
no adverse events occurred. The burden of the patients will be minimized to the
time necessary for completing the questionnaires and tests.
De Boelelaan 1105
Amsterdam 1081 HV
NL
De Boelelaan 1105
Amsterdam 1081 HV
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66769.029.18 |
| OMON | NL-OMON22196 |