Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery

• ClinicalTrials.gov Identifier: NCT02416973
• Recruitment Status: Completed
• First Posted: April 15, 2015
• Results First Posted: February 9, 2017
• Last Update Posted: February 9, 2017
• Sponsor: Regenesis Biomedical, Inc.
• Information provided by (Responsible Party): Regenesis Biomedical, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Surgery	Device: Provant	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: March 2015
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Sham of Provant; Sham of Provant	Device: Provant
Active Treatment; Active Provant Treatment	Device: Provant
Active Treatment with alternative settings; Active Provant Treatment with alternative settings	Device: Provant

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Pain Scores [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Alabama

AOC-Research

Birmingham, Alabama, United States, 35209

United States, Arizona

Hope Research

Phoenix, Arizona, United States, 85018

United States, Idaho

Injury Care Research

Boise, Idaho, United States, 83713

United States, Illinois

Rockford Orthopedic

Rockford, Illinois, United States, 61114

United States, Nevada

Hope Research_Las Vegas

Las Vegas, Nevada, United States, 89106

United States, North Carolina

Tarheel Clinical Research

Raliegh, North Carolina, United States, 27612

United States, South Carolina

Upstate Clinical

Spartanburg, South Carolina, United States, 29303

United States, Virginia

Danville Orthopedic

Danville, Virginia, United States, 24541

Sponsors and Collaborators

Regenesis Biomedical, Inc.

More Information

• Responsible Party: Regenesis Biomedical, Inc.
• ClinicalTrials.gov Identifier: NCT02416973
• Other Study ID Numbers: RBI.2015.001
• First Posted: April 15, 2015
• Results First Posted: February 9, 2017
• Last Update Posted: February 9, 2017
• Last Verified: December 2016