Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Kourosh Zarghooni, University of Cologne
ClinicalTrials.gov Identifier:
NCT01279174
First received: January 18, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Coxarthrosis
Other: Conventional physiotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Whole Body Vibration Compared to Conventional Physiotherapy in Patients With Coxarthrosis: a Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Changes in Womac [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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:
  • SF-12 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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

  • Leonardo Mechanography [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: Whole-body-vibration exercises
Patients in this study group will attend whole body vibration exercise sessions of one hour three times a week for six weeks, using the Galileo® Fitness device. Initial training sessions will focus on patient acclimatization, and afterwards improved on muscular capacity and body coordination. During exercise sessions, patients will do 6 training cycles of 3 minutes each. The goals of this treatment are improved proprioception of the ankle and knee joints, as well as optimization of neuronal reactivation of the muscles and thereby improved joint stability. This should also increase endogenous analgesia
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

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279174

Contacts
Contact: Peter Knöll +49(0)221-478-87294 peter.knoell@uk-koeln.de

Locations
Germany
University Hospital Recruiting
Cologne, Germany, 50924
Contact: Peter Knöll    +49(0)221-478-87294    studienzentrum-ortho-unfall@uk-koeln.de   
Principal Investigator: Kourosh Zarghooni         
Sub-Investigator: Peter Knöll         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Peter Knöll University Hospital of Cologne
  More Information

No publications provided

Responsible Party: Kourosh Zarghooni, Dr.med., University of Cologne
ClinicalTrials.gov Identifier: NCT01279174     History of Changes
Other Study ID Numbers: Ortho-Koeln-1-2011, Version V1.55
Study First Received: January 18, 2011
Last Updated: May 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hip, arthrosis

Additional relevant MeSH terms:
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014