Clinical trial NCT02416973: Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Surgery
Lead sponsor: Regenesis Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-15
Enrollment: 41
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in Pain Scores
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AOC-Research
state: Alabama
city: Phoenix
country: United States
facility: Hope Research
state: Arizona
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Rockford
country: United States
facility: Rockford Orthopedic
state: Illinois
city: Las Vegas
country: United States
facility: Hope Research_Las Vegas
state: Nevada
city: Raliegh
country: United States
facility: Tarheel Clinical Research
state: North Carolina
city: Spartanburg
country: United States
facility: Upstate Clinical
state: South Carolina
city: Danville
country: United States
facility: Danville Orthopedic
state: Virginia
Study officials:
References: