Clinical trial NCT01279174: Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
Official title: Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Coxarthrosis: a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coxarthrosis
Keywords: Hip, arthrosis
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is generally higher than that of coxarthrosis.

Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through either mobility or medication. Non-pharmacologic treatment is the first step, followed by the addition of analgesic medication, and ultimately by surgery.

The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function, which in turn both prevents formation of and delays progression of OA. A modification of conventional physiotherapy, whole body vibration has been successfully employed for several years. Since its introduction, this therapy is in wide use at our facility not only for gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.

Detailed description: This study is a randomized, therapy-controlled trial in a primary care setting at a university hospital. Patients presenting to our outpatient clinic with initial symptoms of coxarthrosis will be assessed against inclusion and exclusion criteria. After patient consent, 6 weeks of treatment will ensue. During the six weeks of treatment, patients will receive one of two treatments, conventional physiotherapy or whole-body-vibration exercises of one hour three times a week. Follow-up examinations will be performed immediately after treatment and after another 6 and 20 weeks, for a total study duration of 6 months. 20 patients will be included in each therapy group.

Eligibility criteria: Inclusion Criteria:

* Age 30 - 80 years
* Body weight less than or equal to 160 kg
* Body-Mass-Index less than 40 kg/m²
* Outpatient
* Legal competence
* Signed informed consent
* Uni- or bilateral Coxarthrosis according to ACR criteria
* WOMAC-pain index (visual analogue scale) of 30-70 mm
* Coxarthrosis stage II-III according to Kellgren and Lawrence

Exclusion Criteria:

* Participation in parallel interventional studies
* Bilateral Coxarthrosis with WOMAC Pain index more than 70 mm
* Previous surgery during the past 6 months at the Index Joint
* Injury of the study joint during the last 6 months
* Secondary rheumatoid or septic arthrosis or systemic diseases affecting the study joint
* Activated coxarthrosis with intraarticular effusion
* Body weight \> 160 kg or body mass index \> 40 kg/m²
* Analgesic therapy with steroidal drugs
* Physiotherapy of the lower extremities during the past 6 weeks
* Existing endoprosthetics in the lower extremities

Primary outcomes:
measure: Changes in Womac
timeFrame: 26 weeks
Secondary outcomes:
measure: SF-12
timeFrame: 26 weeks
measure: Leonardo Mechanography
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital
Study officials:
affiliation: University Hospital of Cologne
name: Peter Knöll
role: PRINCIPAL_INVESTIGATOR
References: