Lumbar Surgery
Conditions
Brief 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.
Interventions
DEVICEProvant
Sponsors
Regenesis Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject age is greater than or equal to 22 years. 2. Subject has undergone one or two anatomically successful lumbar back surgeries for the treatment of low back pain. 3. Subject has persistent pain in the low back and/or radiating pain to leg(s) for \> 3 months and \< 36 months following the most recent surgery. If radiating leg pain is occurring in both legs, one leg, which has the worst Average Pain Intensity over the week prior to the Screening Visit, will be selected as the index leg. 4. Subject has been receiving medication for persistent post-operative low back and/or radiating leg pain, including opioid or non-opioid analgesic medication, and is on a stable analgesic dosing regimen (i.e. the same medications and dosages) for \> 30 days prior to the Screening Visit. 5. Average Pain Intensity (calculated as the mean of the daily Average Pain Intensity scores for either back and/or leg) is ≥ 3 and \< 9 as measured on Numeric Pain Rating Scale (NPRS) during the 10-day run-in period. 6. Subject has completed a minimum of 80% (8 of 10 possible) of the electronic Patient Reported Outcome (ePRO) assessments during the 10 day run-in period. 7. Subject is able to access an internet browser in the home environment. 8. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol. 9. 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 has a history of more than two lumbar spine surgeries. 2. Subject requires additional lumbar surgery or surgery of any type prior to Day 75. 3. Subject had disc fusion at any level in the most recent surgery. 4. 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. 5. Subject has undergone any local injection into the lumbar spine within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products. 6. Subject has used systemic corticosteroids within 2 months of the Screening Visit. 7. Subject has a history of any uncontrolled medical illness that in the investigator's judgment places the subject at unacceptable risk for receipt of PEMF therapy. 8. Subject has a history of malignancy within the past five years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized in situ carcinoma of the cervix. 9. Subject has an ongoing painful condition that in the opinion of the investigator might have a confounding influence on the safety or effectiveness analyses for this study. 10. Subject has a serious psychosocial co-morbidity. 11. Subject has a history of drug or alcohol abuse within one year prior to screening. 12. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s). 13. Subject consumes an average of \> 100 mg oral Morphine Sulfate equivalents per day during the 10 day run-in period. 14. Standard deviation around the mean of the average pain intensity scores during the 10 day run-in period is \> 2.0. 15. Subject has a Body Mass Index (BMI) \> 38 kg/m2. 16. Subject is currently pregnant or planning on becoming pregnant prior to Day 75. 17. Subject has been previously treated with the PROVANT Therapy System. 18. Subject is in current litigation regarding back pain or is receiving Worker's Compensation. 19. Subject is unwilling or unable to follow study instructions, comply with the treatment regimen, study visits, and ePRO assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Pain Scores | 60 days | Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham of Provant Sham of Provant
Provant | 14 |
| Active Treatment Active Provant Treatment
Provant | 13 |
| Active Treatment With Alternative Settings Active Provant Treatment with alternative settings
Provant | 14 |
| Total | 41 |
Baseline characteristics
| Characteristic | Active Treatment | Active Treatment With Alternative Settings | Sham of Provant | Total |
|---|---|---|---|---|
| Age, Continuous | 54.9 years | 50.2 years | 50.6 years | 51.83 years |
| Gender Female | 5 Participants | 7 Participants | 9 Participants | 21 Participants |
| Gender Male | 8 Participants | 7 Participants | 5 Participants | 20 Participants |
| PainDETECT Questionnaire | 14.5 units on a scale | 16.1 units on a scale | 16.6 units on a scale | 15.8 units on a scale |
| Region of Enrollment United States | 13 participants | 14 participants | 14 participants | 41 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 14 | 6 / 13 | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 14 |
Outcome results
Primary
Percent Change From Baseline in Pain Scores
Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).
Time frame: 60 days
Population: Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham of Provant | Percent Change From Baseline in Pain Scores | -25.6 Percent Difference | Standard Deviation 24.81 |
| Active Treatment | Percent Change From Baseline in Pain Scores | -40.2 Percent Difference | Standard Deviation 26.35 |
| Active Treatment With Alternative Settings | Percent Change From Baseline in Pain Scores | -18.6 Percent Difference | Standard Deviation 39.47 |