Low Level Magnetic Fields for the Treatment of Osteoarthritis of the Hip

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Hip

In brief

The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields will help symptoms of painful hip(s)

Key facts

Study ID

NCT01312285

Run by

pico-tesla Magnetic Therapies, LLC

People needed

30

Starts

2011-09-01

Expected to finish

2012-03-01

Last updated by the study team

2011-05-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > Diagnosis of osteoarthritis of the hip for at least one hip (right or left hip, or both hips) determined by satisfaction of BOTH of the following (as outlined in the STUDY TEST BATTERY section above):
• the American College of Rheumatology (ACR) Classification Criteria for osteoarthritis of the hip, AND
• Rating of current Degree of Pain in the hip on the 0-100 Visual Analog Scale of 40 or greater.
• N.B.: If both hips satisfy both of the above criteria for diagnosis of osteoarthritis of the hip, the hip with the highest VAS pain rating will be selected for evaluation in this study. That is, only one hip per subject will be evaluated in this study.
• Hip pain was present on most days of the prior three months.
• Subject is ambulatory.
• Subject's use of pain relief medication(s) has been stable over the past 30 days, and the subject is willing and able to maintain this existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
• Subject has been on current non-pain relief medication regimen (for any indication or condition such as hypertension, pulmonary disease or cardiac disease), unchanged, or on no current non-pain relief medication regimen, for at least 30 days prior to study enrollment, and is willing and able to maintain his or her regular non-pain relief medication regimen, unchanged, throughout the course of his or her study participation unless the subject's physician states that a medication change is needed for the subject's safety and well-being, in which case the subject agrees to inform the study PI of the change(s) made ,.
• Willing and able to abstain from partaking in other/new treatments (other than the study procedures) to improve osteoarthritis of the hip pain and other symptoms during the course of participation in the study. Such treatments include new medications, dietary/herbal supplements/ minerals, weight loss programs, water or other new exercise programs, physical therapy, occupational therapy, surgical procedures, and alternative therapies such as acupuncture, massage, or hypnotherapy.
• Adequate contraceptive measures for female subjects. > 18 years of age or older.
• Male or female.

You may not qualify if…

• > Neither the right nor the left hip satisfies BOTH of the following criteria for a diagnosis of osteoarthritis of the hip (as outlined in the STUDY TEST BATTERY section):
• the American College of Rheumatology (ACR) Classification Criteria for osteoarthritis of the hip, AND
• Rating of current Degree of Pain in the hip on the 0-100 Visual Analog Scale of 40 or greater.
• Hip pain was not present on most days of the prior three months.
• Subject is non-ambulatory.
• Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device, or from attending any of the scheduled study visits during the planned study duration, or from completing any of the study measures.
• Any other significant comorbidities that might impact the ability to evaluate the subject's satisfaction of the American College of Rheumatology Classification Criteria for osteoarthritis of the hip, or for the subject to complete any of the study assessment tools.
• Subject's use of pain relief medication(s) has not been stable over the past 30 days and/or the subject is not willing and/or unable to maintain this existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
• Not willing and/or unable to abstain from partaking in new treatments (other than the study procedures) to improve osteoarthritis of the hip pain and other symptoms during the course of participation in the study. Such treatments include new medications, dietary/herbal supplements/minerals, weight loss programs, water or other new exercise programs, physical therapy, occupational therapy, surgical procedures, and alternative therapies such as acupuncture, massage, or hypnotherapy.
• An intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the prior three months.
• Known inflammatory rheumatic disease.
• Epilepsy/history of seizures/taking medication for epilepsy.
• HIV and other autoimmune disorders.
• Active cancer or treatment for cancer within last 6 months.
• Confirmed active infection(s).
• Signs of clinically important active inflammation of the hip joint including redness, warmth, swelling and/or a large, bulging effusion with the loss of normal contour.
• Acute inflammation or ischaemic necrosis.
• Inflammatory arthropathy of the hip.
• Inflammatory system diseases that could interfere with the evaluation of the study procedure.
• Hip arthropathy due to diabetes mellitus.
• Charcot's joint.
• Villous synovitis.
• Chondromatosis of the synovium.
• Rapid destructive hip.
• History of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy.

Where it is running

• Innovative Research — Clearwater, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.