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NCT Number: NCT01279174

Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

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.

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Key information

Conditions

Coxarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Cologne, 50924, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Physiotherapy

Other

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

Primary outcomes

  1. Changes in Womac

    Time frame: 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 outcomes

  1. SF-12

    Time frame: 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

  2. Leonardo Mechanography

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2011
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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