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CompletedNCT02881112Updated Apr 6, 2020Results posted

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

An interventional study of Provant Therapy System in Pain, sponsored by Regenesis Biomedical, Inc.. Completed at 8 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Regenesis Biomedical, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Active Treatment Arm

    Treatment with Provant Therapy System

    Device: Provant Therapy System

Interventions

  • DeviceProvant Therapy System

    Treatment with the Provant Therapy System

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pain scores collected daily, up to 20 weeks.

06

Results

Posted Nov 25, 2019

Participant flow

Participant flow — Overall Study
MilestoneActive Treatment Arm
Started180
Completed152
Not completed28

Outcome measures

PrimaryPain 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.

Time frame:
Pain scores collected daily, up to 20 weeks.
Reported as:
Mean · score on a scale
Pain Intensity Assessment
score on a scaleActive Treatment Arm
Pain Intensity Assessment-2.785 ± 3.3039

Adverse events

Collected over Through end of treatment, up to 20 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active Treatment Arm0/180 (0%)0/180 (0%)0/180 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Active Treatment Arm
<=18 years0
Between 18 and 65 years105
>=65 years75
Age, Continuous
Age, Continuous(Years)Active Treatment Arm
Mean60.48 (24 to 89)
Sex: Female, Male
Sex: Female, Male(Participants)Active Treatment Arm
Female124
Male56
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Active Treatment Arm
Hispanic or Latino8
Not Hispanic or Latino153
Unknown or Not Reported19
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Active Treatment Arm
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American15
White149
More than one race1
Unknown or Not Reported13
Region of Enrollment
Region of Enrollment(Participants)Active Treatment Arm
United States180
07

Study locations

8 sites
  • AOC-Research, LLC
    Birmingham, Alabama 35209, United States
  • Coolbody Contours
    Scottsdale, Arizona 85251, United States
  • Scottsdale Center for Women's Health
    Scottsdale, Arizona 85258, United States
  • Coastal Orthopedics & Sports Medicine
    Bradenton, Florida 34209, United States
  • Injury Care Research, LLC
    Boise, Idaho 83713, United States
  • Exodus Pain Clinic
    Meridian, Idaho 83642, United States
  • Biogenesis Group, LLC
    Ypsilanti, Michigan 48197, United States
  • Spokane Joint Replacement Center
    Spokane, Washington 99218, United States
08

References and documents

Study documents

  • Study protocol · Jan 18, 2017
  • Statistical analysis plan · Aug 30, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT02881112
Lead sponsor
Regenesis Biomedical, Inc.
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
Mar 2016
Primary completion
Dec 14, 2017
Completion
Dec 14, 2017
Results posted
Nov 25, 2019
Last update
Apr 6, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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