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

NCT01312285 | Withdrawn Phase 2 DMC

• 1 other identifier: 10276-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Osteoarthritis of the Hip

Keywords

osteoarthritis; painful hips

Outcome Measures

Primary Outcomes (1)

• The mean change from baseline to study endpoint in the 3-recording average of the subject's Daily Pain Rating on the 0-100 VAS for the study hip recorded each morning upon waking and prior to consuming any pain medication for the day.

  14 days

Secondary Outcomes (1)

• Daily morning recordings of pain intensity ratings for the study hip on the 0-100 VAS

  14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Device: Resonator device

Resonator Device

EXPERIMENTAL

Device: Resonator device

Interventions

Resonator device DEVICE

low level magnetic fields

Placebo; Resonator Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• pico-tesla Magnetic Therapies, LLC: lead

Study Sites (1)

Innovative Research

Clearwater, Florida, 33756, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: March 10, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 30, 2011

Record last verified: 2011-05

Locations

US (1)