Postoperative PainNCT04300907
An Open-Label Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain
A study testing Provant Infinity Therapy System in people with Postoperative Pain, run by Regenesis Biomedical, Inc. at 4 sites in United States.
Trial summary
A study of the use of the Provant Infinity Therapy System when treatment is administered 30 minutes twice daily for 8-weeks (56 days ± 3 days) at home for postoperative pain. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Provant Infinity Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2020to 24 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subject is ≥ 60 days postoperative. 2. Subject's average chronic postoperative pain over the preceding week is ≥4 and <9, based on the 11-point NPRS (0-10) at the Screening Visit.
- 3. Subject's age is greater than or equal to 22 years and less than 80 years of age.
- 4. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- 5. Female subjects must be postmenopausal, surgically sterile, abstinent, or, if of childbearing potential, practicing (or agrees 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
- 1. Subject has a history of previous solid organ transplant or severe renal disease (i.e. estimated creatinine clearance <30 mL/min).
- 2. Subject has previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection.
- 3. According to the judgment of the Investigator, subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, arrhythmia, cardiac surgery, stent placement or angioplasty, or congestive heart failure).
- 4. Subject has a history of any uncontrolled medical illness that, in the investigator's judgment, places the subject at unacceptable risk for enrollment in a research trial with pulsed electromagnetic field therapy.
- 5. Subject requires or anticipates the need for surgery (other than minor outpatient surgical procedures, such as dental or minor cosmetic procedures) or extended travel during the treatment period.
- 6. Subject has received any investigational drug or device within 30 days prior to the Screening Visit.
Show all 12Show fewer
- 7. Subject has a history of malignancy within the past 5 years in the treatment area.
- 8. Subject has severe mental health or psychiatric disorder that would interfere with study performance and/or assessments in the opinion of the Investigator.
- 9. Subject has a known history of drug or alcohol abuse within one year prior to the Screening Visit.
- 10. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
- 11. Subject is currently pregnant or planning to become pregnant prior to Week 8.
- 12. Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lake Internal Medicine Associates
Eustis, Florida, 32726
Palm Research Center
Las Vegas, Nevada, 89128
Physician's Research Group
Mesa, Arizona, 85206
Valley Clinical Research
Northridge, California, 91325
About this study
A study of the use of the Provant Infinity Therapy System when treatment is administered 30 minutes twice daily for 8-weeks (56 days ± 3 days) at home for postoperative pain.
Read the detailed description
This is an 8-week (56 days ± 3 days), multi-center, open label clinical trial conducted on subjects with chronic postoperative pain.
Eligible subjects will include those between 22 and 80 years of age with chronic postoperative pain at least 60 days following surgery.
At the Screening Visit, eligible subjects will have an average weekly pain score, over the last 7 days of ≥4 and <9 based on the 11-point NPRS (0-10) and will verbally confirm they have chronic postoperative pain from surgery ≥ 60 days prior . After signing Informed Consent and verifying subject eligibility for the trial (including a pain score assessment using the NPRS), subjects will have demographic information, medical/surgical history and medication use reviewed and recorded. An abbreviated physical examination, including height and weight, will be performed. A urine pregnancy test will be performed on women of childbearing potential.
Screening and Baseline (Day 0) / Enrollment may occur on the same day. During the Enrollment visit, subjects will receive study device training and be dispensed a study device with instructions to self-treat twice daily (morning and evening; 8am ± 2 hours and 8pm ± 2 hours) for 8 weeks (56 days ± 3 days).
If Screening and Enrollment are not on the same day, subjects returning to the clinic for Baseline (Day 0) will have an additional review of eligibility, medical history, adverse events and concomitant medications prior to device training and dispensation.
Subjects will receive a telephone call at Week 2 / Day 14 (±3 days). During the phone call subjects will have adverse events, and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use questions will be captured.
Subjects will receive a telephone call at Week 4 / Day 28 (±3 days). During the phone, call subjects will have adverse events, and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use questions will be captured.
Subjects will receive a telephone call at Week 6 / Day 42 (±3 days). During the phone, call subjects will have adverse events, and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use questions will be captured.
At the Week 8 / Day 56 (±3 days) End of Study Visit, subjects will have adverse events and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use and Feedback questions will be captured and the study device will be returned.
- Conditions
- Postoperative Pain
- Being tested
- Provant Infinity Therapy System
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provant Infinity Therapy SystemDevice
Treatment with the Provant Infinity Therapy System, PEMF device
| Study group | Role | What they receive |
|---|---|---|
| Provant Infinity Therapy | Experimental | Open-label treatment with Provant Infinity Therapy Receives: Device: Provant Infinity Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Use Questionnaire
4 question questionnaire on device usage (total of all responses will be counted at the end of the study); response will require a "Yes" or "No" answer
Measured: Week 8
Secondary outcomes (2)
Device Feedback Questionnaire
5 question questionnaire about the study device; device use questions will be open text, "Yes" or "No" answers or rated from "Extremely Easy/Extremely Comfortable" to "Extremely Difficult/Extremely Uncomfortable"
Measured: Week 8
Numeric Pain Rating Scale (NPRS)
11-point numerical rating scale for pain (0 = no pain to 10 = worst possible pain)
Measured: Weeks 2, 4, 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Mar 2020
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Model description
- open-label
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04300907
- Sponsor's protocol ID
- RBI.2020.002
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain
- ClinicalTrials.gov ID
- NCT04300907
- Acronym / sponsor ID
- RBI.2020.002
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the use of the Provant Infinity Therapy System when treatment is administered 30 minutes twice daily for 8-weeks (56 days ± 3 days) at home for postoperative pain.
Detailed description
This is an 8-week (56 days ± 3 days), multi-center, open label clinical trial conducted on subjects with chronic postoperative pain.
Eligible subjects will include those between 22 and 80 years of age with chronic postoperative pain at least 60 days following surgery.
At the Screening Visit, eligible subjects will have an average weekly pain score, over the last 7 days of ≥4 and <9 based on the 11-point NPRS (0-10) and will verbally confirm they have chronic postoperative pain from surgery ≥ 60 days prior . After signing Informed Consent and verifying subject eligibility for the trial (including a pain score assessment using the NPRS), subjects will have demographic information, medical/surgical history and medication use reviewed and recorded. An abbreviated physical examination, including height and weight, will be performed. A urine pregnancy test will be performed on women of childbearing potential.
Screening and Baseline (Day 0) / Enrollment may occur on the same day. During the Enrollment visit, subjects will receive study device training and be dispensed a study device with instructions to self-treat twice daily (morning and evening; 8am ± 2 hours and 8pm ± 2 hours) for 8 weeks (56 days ± 3 days).
If Screening and Enrollment are not on the same day, subjects returning to the clinic for Baseline (Day 0) will have an additional review of eligibility, medical history, adverse events and concomitant medications prior to device training and dispensation.
Subjects will receive a telephone call at Week 2 / Day 14 (±3 days). During the phone call subjects will have adverse events, and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use questions will be captured.
Subjects will receive a telephone call at Week 4 / Day 28 (±3 days). During the phone, call subjects will have adverse events, and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use questions will be captured.
Subjects will receive a telephone call at Week 6 / Day 42 (±3 days). During the phone, call subjects will have adverse events, and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use questions will be captured.
At the Week 8 / Day 56 (±3 days) End of Study Visit, subjects will have adverse events and concomitant medications reviewed. Average weekly pain score (using the NPRS), Patient Global Impression (PGI), Treatment Satisfaction and Device Use and Feedback questions will be captured and the study device will be returned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label
| Arm | Type | Receives |
|---|---|---|
| Provant Infinity Therapy | Experimental | Device: Provant Infinity Therapy SystemOpen-label treatment with Provant Infinity Therapy |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Subject is ≥ 60 days postoperative. 2. Subject's average chronic postoperative pain over the preceding week is ≥4 and <9, based on the 11-point NPRS (0-10) at the Screening Visit.
- 3. Subject's age is greater than or equal to 22 years and less than 80 years of age.
- 4. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
- 5. Female subjects must be postmenopausal, surgically sterile, abstinent, or, if of childbearing potential, practicing (or agrees 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 (12 listed)
- 1. Subject has a history of previous solid organ transplant or severe renal disease (i.e. estimated creatinine clearance <30 mL/min).
- 2. Subject has previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection.
- 3. According to the judgment of the Investigator, subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, arrhythmia, cardiac surgery, stent placement or angioplasty, or congestive heart failure).
- 4. Subject has a history of any uncontrolled medical illness that, in the investigator's judgment, places the subject at unacceptable risk for enrollment in a research trial with pulsed electromagnetic field therapy.
- 5. Subject requires or anticipates the need for surgery (other than minor outpatient surgical procedures, such as dental or minor cosmetic procedures) or extended travel during the treatment period.
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 Infinity Therapy SystemTreatment with the Provant Infinity Therapy System, PEMF device | Device | Provant Infinity Therapy |
Primary outcome
Device Use Questionnaire
Time frame: Week 8
4 question questionnaire on device usage (total of all responses will be counted at the end of the study); response will require a "Yes" or "No" answer
2 secondary outcomes
Device Feedback Questionnaire
Time frame: Week 8
Numeric Pain Rating Scale (NPRS)
Time frame: Weeks 2, 4, 6 and 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provant Infinity Therapy System in people with Postoperative Pain, run by Regenesis Biomedical, Inc. at 4 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 12 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: withdrawn, 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 4 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Device Use Questionnaire (time frame: Week 8). 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.