NCT04300907

An Open-Label Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Regenesis Biomedical, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Provant Infinity Therapy System	Treatment with the Provant Infinity Therapy System, PEMF device

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2020-03-09
• Last updated: 2020-04-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study