Clinical trial NCT02881112: A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies
Official title: An Open-Label, Non-Controlled Study to Evaluate Outcomes of Pulsed Electromagnetic Field (PEMF) Therapy in Subjects With Various Pain Etiologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Regenesis Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 180
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity Assessment
timeFrame: Pain scores collected daily, up to 20 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AOC-Research, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Coolbody Contours
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Center for Women's Health
state: Arizona
city: Bradenton
country: United States
facility: Coastal Orthopedics & Sports Medicine
state: Florida
city: Boise
country: United States
facility: Injury Care Research, LLC
state: Idaho
city: Meridian
country: United States
facility: Exodus Pain Clinic
state: Idaho
city: Ypsilanti
country: United States
facility: Biogenesis Group, LLC
state: Michigan
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References: