PainNCT02881112
A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies
A study testing Provant Therapy System in people with Pain, run by Regenesis Biomedical, Inc. at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Provant Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2016to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age is greater than or equal to 22 years.
- Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment with Provant is warranted.
- Subject is willing and able to give written informed consent.
- 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).
Who cannot join
- Subject requires or anticipates the need for surgery of any type during the duration of treatment.
- 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.
- Subject has used systemic corticosteroids within 2 months of the Screening Visit.
- 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.
- Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
- Subject has a serious psychosocial co-morbidity.
Show all 11Show fewer
- Subject has a history of drug or alcohol abuse within one year prior to the Screening Visit.
- Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- Subject is currently pregnant or planning on becoming pregnant during the treatment period.
- Subject has been previously treated with the Provant Therapy System.
- Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
AOC-Research, LLC
Birmingham, Alabama, 35209
Injury Care Research, LLC
Boise, Idaho, 83713
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209
Exodus Pain Clinic
Meridian, Idaho, 83642
Coolbody Contours
Scottsdale, Arizona, 85251
Scottsdale Center for Women's Health
Scottsdale, Arizona, 85258
Spokane Joint Replacement Center
Spokane, Washington, 99218
Biogenesis Group, LLC
Ypsilanti, Michigan, 48197
About this study
Official title: 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.
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.
- Conditions
- Pain
- Being tested
- Provant Therapy System
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provant Therapy SystemDevice
Treatment with the Provant Therapy System
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Arm | Experimental | Treatment with Provant Therapy System Receives: Device: Provant Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pain scores collected daily, up to 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMar 2016
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenesis Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881112
- Sponsor's protocol ID
- RBI.2015.005
- Status last verified
- Apr 2020
- First submitted
- 30 Jun 2016
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Controlled Study to Evaluate Outcomes of Pulsed Electromagnetic Field (PEMF) Therapy in Subjects With Various Pain Etiologies
- ClinicalTrials.gov ID
- NCT02881112
- Acronym / sponsor ID
- RBI.2015.005
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm | Experimental | Device: Provant Therapy SystemTreatment with Provant Therapy System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject age is greater than or equal to 22 years.
- Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment with Provant is warranted.
- Subject is willing and able to give written informed consent.
- 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).
Key exclusion criteria (11 listed)
- Subject requires or anticipates the need for surgery of any type during the duration of treatment.
- 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.
- Subject has used systemic corticosteroids within 2 months of the Screening Visit.
- 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.
- Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provant Therapy SystemTreatment with the Provant Therapy System | Device | Active Treatment Arm |
Primary outcome
Pain Intensity Assessment
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provant Therapy System in people with Pain, run by Regenesis Biomedical, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessment (time frame: Pain scores collected daily, up to 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.