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Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Coxarthrosis: a Randomized, Controlled Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01279174
Enrollment
40
Registered
2011-01-19
Start date
2012-06-30
Completion date
2015-10-31
Last updated
2015-12-09

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

Conditions

Coxarthrosis

Keywords

Hip, arthrosis

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.

Interventions

OTHERConventional physiotherapy

Patients in this study group will attend physiotherapeutic exercise sessions of one hour three times a week for six weeks. The sessions consist of aerobic and muscle strengthening as well as coordination exercises. Patients will practice activities of daily living. The goals of these exercises are to improve joint stability, optimize knee and ankle proprioception, and advance neuromuscular innervation of the lower extremity and thereby suppress pathologic motion patterns. This should lead to optimized mobility, increased stability, and thus more endogenous analgesia of the affected joint

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Womac26 weeksThe primary outcome measure is the patients' evaluation of improvement on the visual analogue scale of the WOMAC indices for pain and activities of daily life, comparing baseline and post-treatment. The secondary outcome measures summarized in the appendices will also be assessed at baseline and after 6, 12, and 26 weeks

Secondary

MeasureTime frameDescription
SF-1226 weeksThe SF-12 score uses subjective patient responses to measure success of therapy and thereby evaluate quality of life. SF-12 is the abbreviated version of the SF-36 Health Survey and contains 12 items representing 8 dimensions of physical and mental fitness. In our study, the validated German translation will be used
Leonardo Mechanography26 weeksFunctional motion analysis, the Modified Clinical Test of Sensory Interaction in Balance, the Tandem Walk Test, and the Rhythmic Weight Shift Test will be performed using the Leonardo Mechanography Gangway (Novotec Inc., Pforzheim, Germany) and the Balance Master Analysis System (Neurocom Inc., Clackamas, USA). These will provide reliable data on essential parts of ambulation, e.g. stride length, speed of movement, shifting of balance point, force, power, and workload

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026