Pain
Conditions
Brief 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.
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.
Interventions
DEVICEProvant Therapy System
Treatment with the Provant Therapy System
Sponsors
Regenesis Biomedical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject age is greater than or equal to 22 years. 2. Subject has pain (chronic or acute) and/or edema that the prescriber deems treatment with Provant is warranted. 3. Subject is willing and able to give written informed consent. 4. 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
1. Subject requires or anticipates the need for surgery of any type during the duration of treatment. 2. 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. 3. Subject has used systemic corticosteroids within 2 months of the Screening Visit. 4. 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. 5. Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma). 6. Subject has a serious psychosocial co-morbidity. 7. Subject has a history of drug or alcohol abuse within one year prior to the Screening Visit. 8. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s). 9. Subject is currently pregnant or planning on becoming pregnant during the treatment period. 10. Subject has been previously treated with the Provant Therapy System. 11. Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Assessment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Arm Treatment with Provant Therapy System
Provant Therapy System: Treatment with the Provant Therapy System | 180 |
| Total | 180 |
Baseline characteristics
| Characteristic | Active Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 75 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants |
| Age, Continuous | 60.48 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 149 Participants |
| Region of Enrollment United States | 180 Participants |
| Sex: Female, Male Female | 124 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 180 |
| other Total, other adverse events | 0 / 180 |
| serious Total, serious adverse events | 0 / 180 |
Outcome results
Primary
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.
Time frame: Pain scores collected daily, up to 20 weeks.
Population: Subjects recording both a Baseline and End of Study score were included in the NPRS analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment Arm | Pain Intensity Assessment | -2.785 score on a scale | Standard Deviation 3.3039 |