N/A
Completed N=180
A Registry Study to Evaluate Outcomes of PEMF Therapy in Subjects With Various Pain Etiologies
Source: ClinicalTrials.gov NCT02881112 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Pain Intensity Assessment — -2.785 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Assessment |
-2.785 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02881112). 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. Informational only — not medical advice.