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

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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:
Information provided by (Responsible Party):
Regenesis Biomedical, Inc.

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 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

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



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).



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416973


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.

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