Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

Phase 4

Completed

• Conditions: Coxarthrosis

• Registration Number: NCT01279174
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Study Start: 2012-06
• Primary Completion: 2015-06
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Womac	26 weeks	The 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 Outcome Measures

Name	Time	Method
Leonardo Mechanography	26 weeks	Functional 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
SF-12	26 weeks	The 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

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Cologne, Germany