Osteoarthritis Clinical Study Information


The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease.

 

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STUDY TEST BATTERY (Part 4)

  • Lequesne Index of Severity for Osteoarthritis of the Hip, Lequesne et al.
    Lequesne et al developed an index of severity for hip osteoarthritis that is in the form of a self-administered questionnaire that assesses pain, function, and stiffness in the hip of osteoarthritis patients. The Lequesne Index was driven by physician judgment and has been extensively validated in osteoarthritis and used to assess the effectiveness of therapeutic interventions.

    There are three sections to the index:
    1. pain or discomfort
    2. maximum distance walked
    3. activities of daily living

    References:
    • Lequesne M Mery C et al. Indexes of severity for osteoarthritis of the hip and knee. Scand J Rheumatology. 1987; Supplement 65: 85-89.
    • Lequesne M. Indices of severity and disease activity for osteoarthritis. Seminars in Arthritis and Rheumatism. 1991; 20 (supplement 2): 48-54.
    • Lequesne MG. The algofunctional indices for hip and knee osteoarthritis. J Rheumatol. 1997; 24: 779-781.The Lequesne Index is contained in Appendix B.
  • Range of Motion
  • Physician‘s assessment of range of motion of the affected hip joint will be recorded as follows:

  • Rescue Pain Medication Diary
  • Pain medication used in this study to relieve hip pain will be standardized within a subject. Subjects will record their use of this rescue pain rescue medication, as applicable, in a daily subject diary. The subject daily diary is contained in Appendix D of this protocol, within the case report forms.
  • Body Pain Diary
  • Subjects will maintain a body pain diary, as follows:
    • Pain level will be recorded for the following body locations, right and left sides separately, as applicable: neck, shoulders, upper back, lower back, hips, thighs, knees, calves, ankles, feet, arms, elbows, and hands.
    • Pain level for each area will be recorded numerically on a 0 to 10 scale, where "0" = "no pain" and "10" = "worst (most severe) pain."

    The Body Pain Diary is contained in Appendix D of this protocol, within the case report forms.

 


 
 

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.