N/A
N=41
Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery
Lumbar Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02416973 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Percent Change From Baseline in Pain Scores — -25.6; -40.2; -18.6 Percent Difference
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Provant (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Regenesis Biomedical, Inc.
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Pain Scores |
-25.6; -40.2; -18.6 | — |
Summary
To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to sham treatment in patients with persistent pain following lumbar surgery when treatment is administered twice daily over a 60 day period.
Eligibility Criteria
Inclusion Criteria
- Subject age is greater than or equal to 22 years.
- Subject has undergone one or two anatomically successful lumbar back surgeries for the treatment of low back pain.
- Subject has persistent pain in the low back and/or radiating pain to leg(s) for > 3 months and 30 days prior to the Screening Visit.
- Average Pain Intensity (calculated as the mean of the daily Average Pain Intensity scores for either back and/or leg) is ≥ 3 and 100 mg oral Morphine Sulfate equivalents per day during the 10 day run-in period.
- Standard deviation around the mean of the average pain intensity scores during the 10 day run-in period is > 2.0.
- Subject has a Body Mass Index (BMI) > 38 kg/m2.
- Subject is currently pregnant or planning on becoming pregnant prior to Day 75.
- Subject has been previously treated with the PROVANT Therapy System.
- Subject is in current litigation regarding back pain or is receiving Worker's Compensation.
- Subject is unwilling or unable to follow study instructions, comply with the treatment regimen, study visits, and ePRO assessments.
Data sourced from ClinicalTrials.gov (NCT02416973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.