Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

NCT01279174 | Completed Phase 4

• 2 other identifiers: Ortho-Koeln-1-2011Version V1.55
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coxarthrosis

Keywords

Hip, arthrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• SF-12

  26 weeks

• Leonardo Mechanography

  26 weeks

Study Arms (2)

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

Other: Conventional physiotherapy

Whole-body-vibration exercises

EXPERIMENTAL

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

Interventions

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

Conventional physiotherapy; Whole-body-vibration exercises

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital

Cologne, 50924, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Peter Knöll

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

DE (1)