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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881112
• Other study ID #: RBI.2015.005
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: April 2020
• Source: Regenesis Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Provant Therapy System
Treatment with the Provant Therapy System

Locations

Country	Name	City	State
United States	AOC-Research, LLC	Birmingham	Alabama
United States	Injury Care Research, LLC	Boise	Idaho
United States	Coastal Orthopedics & Sports Medicine	Bradenton	Florida
United States	Exodus Pain Clinic	Meridian	Idaho
United States	Coolbody Contours	Scottsdale	Arizona
United States	Scottsdale Center for Women's Health	Scottsdale	Arizona
United States	Spokane Joint Replacement Center	Spokane	Washington
United States	Biogenesis Group, LLC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Regenesis Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Assessment	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.	Pain scores collected daily, up to 20 weeks.