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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Provant Therapy System

• Registration Number: NCT02881112
• Lead Sponsor: Regenesis Biomedical, Inc.

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14
• Results First Submitted: 2019-09-23
• Results First Submitted QC: 2019-11-04
• Results First Posted: 2019-11-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Treatment Arm	Provant Therapy System	Treatment with Provant Therapy System

Primary Outcome Measures

Name	Time	Method
Pain Intensity Assessment	Pain scores collected daily, up to 20 weeks.	Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.

Trial Locations

Locations (8)

AOC-Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Scottsdale Center for Women's Health; 🇺🇸 Scottsdale, Arizona, United States

Coolbody Contours; 🇺🇸 Scottsdale, Arizona, United States

Exodus Pain Clinic; 🇺🇸 Meridian, Idaho, United States

Spokane Joint Replacement Center; 🇺🇸 Spokane, Washington, United States

Biogenesis Group, LLC; 🇺🇸 Ypsilanti, Michigan, United States

Coastal Orthopedics & Sports Medicine; 🇺🇸 Bradenton, Florida, United States

Injury Care Research, LLC; 🇺🇸 Boise, Idaho, United States