Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

NCT ID: NCT01279174

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-10-31

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.

Conditions

Coxarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Conventional physiotherapy

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Conventional physiotherapy

Intervention Type: 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

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Kourosh Zarghooni

Dr.med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Knöll

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Locations

University Hospital

Cologne, , Germany

Countries

Germany

Other Identifiers

Version V1.55

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Ortho-Koeln-1-2011

Identifier Type: -

Identifier Source: org_study_id