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Walking ALteration for Knee osteoarthritis.

Walking ALteration for Knee osteoarthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26376
Enrollment
144
Registered
2017-03-03
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis Knee extension deficit Conservative treatment Physiotherapy protocol

Interventions

Patients will be randomized in a group (a) control group: physiotherapy with a standardised treatment protocol based on the KNGF (royal Dutch association of physiotherapists) guidelines. (b) index

Sponsors

Raad van bestuur Máxima Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Symptomatic knee OA according to the clinical ACR criteria. Radiographic OA, according to Kellgren and Lawrence grade 1, 2 or 3 Flexion contracture of 5 degrees or more.

Exclusion criteria

Exclusion criteria: - Medial or lateral instability of the knee, - Symptomatic bilateral knee OA - Intra-articular injection of the knee, in the previous 3 months - Previous peri-articular osteotomy of the affected knee - Symptomatic OA of hip or ankle - Co morbidity which disables the function of the lower extremity - Rheumatoid Arthritis or other inflammatory joint disease - Physical therapy for current complaints during last 3 months - Insufficient command of the Dutch language - Legally incompetent adults

Design outcomes

Primary

MeasureTime frame
Between group difference in change in pain score of the KOOS between baseline and 3 months follow-up.

Secondary

MeasureTime frame
- Comparison of percentage of responders according to the OMERACT/OARSI set of responder criteria, during 12 months follow up, in the control and index group. To measure pain and function, the Number Rating Scale for knee pain (NRS) and KOOS physical function will be used, while for global assessment a Likert scale will be used. These outcomes will be assessed during the first 3 months of the study: weekly, and thereafter: at 6, 9 and 12 months after baseline measurement. After 3 and 12 months of follow-up groups will be compared concerning change since baseline of: - Number Rating Scale for knee pain (NRS) - EQ-5D; Intermittent and Constant OsteoArthritis Pain (ICOAP); - treatment failure (TKA during follow-up; or in “need for TKA” OARSI-criteria after 12 months; or other surgical interventions of the knee during follow-up (osteotomy of high tibia or low femur; arthroscopic intervention; UKA)); - Range of motion of the knee (ROM) - gait parameters as assessed by gait analyses - medication use. To get more insight in which specific patients will respond on the current intervention also the HADS, Central Sensitization Inventory, pain drawing form and pain cognition list will be evaluated.

Contacts

Public ContactJ.J. Tolk
The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)