Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

Coxarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279174
• Other study ID #: Ortho-Koeln-1-2011
• Secondary ID: Version V1.55
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2011
• Last updated: December 8, 2015
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Other:
• Conventional 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

Locations

Country	Name	City	State
Germany	University Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Womac	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	26 weeks	No
Secondary	SF-12	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	26 weeks	No
Secondary	Leonardo Mechanography	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	26 weeks	No