Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

Sponsor

University of Cologne (Other)

Overall Status

Completed

CT.gov ID

NCT01279174

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coxarthrosis	Other: Conventional physiotherapy	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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	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

Arm

Intervention/Treatment

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

Other: Conventional physiotherapy

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Cologne		Germany	50924

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator: Peter Knöll, University Hospital of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kourosh Zarghooni, Dr.med., University of Cologne

ClinicalTrials.gov Identifier:

NCT01279174

Other Study ID Numbers:

Ortho-Koeln-1-2011
Version V1.55

First Posted:

Jan 19, 2011

Last Update Posted:

Dec 9, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Kourosh Zarghooni, Dr.med., University of Cologne

Hip, arthrosis

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Dec 9, 2015