A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:22 - Any
Updated:12/17/2017
Start Date:March 2016
End Date:December 14, 2017

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An Open-Label, Non-Controlled Study to Evaluate Outcomes of Pulsed Electromagnetic Field (PEMF) Therapy in Subjects With Various Pain Etiologies

The study is an open-label, non-controlled study of the safety and effectiveness of
investigator determined Provant therapy in subjects with pain and/or edema from various pain
etiologies. Information collected in the study will be entered into a registry database.

This is an open-label, non-controlled trial in subjects with various pain etiologies at
multiple centers in the US. Eligible subjects will include those ≥ 22 years of age that have
been deemed appropriate for treatment with Provant by the study investigator (prescriber).
Subjects will treat based on the treatment prescribed (location, frequency, duration) by the
study investigator.

Data from assessments administered as part of standard of practice will be obtained at
baseline and, at a minimum, at the end of treatment. If the investigator administers
additional assessments during the course of treatment, the data will be collected.

Safety will be assessed during office visits and through review of AE reports and concomitant
treatments and medications. All concomitant drug or non-drug treatments used during the study
will be recorded.

Information collected in the study will be entered into a registry database.

Inclusion Criteria:

1. Subject age is greater than or equal to 22 years.

2. Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment
with Provant is warranted.

3. Subject is willing and able to give written informed consent.

4. Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing
(or agree to practice) an effective method of birth control if they are sexually
active for the duration of the study. (Effective methods of birth control include
prescription hormonal contraceptives, intrauterine devices, double-barrier methods,
and/or male partner sterilization).

Exclusion Criteria:

1. Subject requires or anticipates the need for surgery of any type during the duration
of treatment.

2. Subject has received any investigational drug or device within 30 days or 5 half-lives
of the drug, whichever is longer, prior to the Screening Visit or is enrolled in
another clinical trial.

3. Subject has used systemic corticosteroids within 2 months of the Screening Visit.

4. Subject has a history of a solid tumor that is not in complete remission for greater
than 2 years other than successfully treated non-metastatic basal cell or squamous
cell carcinomas of the skin in the treatment area.

5. Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).

6. Subject has a serious psychosocial co-morbidity.

7. Subject has a history of drug or alcohol abuse within one year prior to the Screening
Visit.

8. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord
stimulator, bone stimulator, cochlear implant, or other implanted device with an
implanted metal lead(s).

9. Subject is currently pregnant or planning on becoming pregnant during the treatment
period.

10. Subject has been previously treated with the Provant Therapy System.

11. Subject is unwilling or unable to follow study instructions, or comply with the
treatment regimen and study visits.
We found this trial at
8
sites
Boise, Idaho 83713
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Boise, ID
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Birmingham, Alabama 35209
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Birmingham, AL
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Bradenton, Florida 34209
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Bradenton, FL
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Meridian, Idaho 83642
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Meridian, ID
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6900 East Camelback Road
Scottsdale, Arizona 85251
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Scottsdale, AZ
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8415 North Pima Road
Scottsdale, Arizona 85258
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Scottsdale, AZ
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Spokane, Washington 99218
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Spokane, WA
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1947 Whittaker Road
Ypsilanti, Michigan 48197
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Ypsilanti, MI
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