NCT02416973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 9, 2017

Completed
Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

March 30, 2015

Results QC Date

October 26, 2016

Last Update Submit

December 19, 2016

Conditions

Lumbar Surgery

Outcome Measures

Primary Outcomes (1)

  • 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).

    60 days

Study Arms (3)

Sham of Provant

OTHER

Sham of Provant

Device: Provant

Active Treatment

OTHER

Active Provant Treatment

Device: Provant

Active Treatment with alternative settings

OTHER

Active Provant Treatment with alternative settings

Device: Provant

Interventions

ProvantDEVICE
Active TreatmentActive Treatment with alternative settingsSham of Provant

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject age is greater than or equal to 22 years.
  • Subject has undergone one or two anatomically successful lumbar back surgeries for the treatment of low back pain.
  • 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.
  • 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.
  • 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.
  • 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.
  • Subject is able to access an internet browser in the home environment.
  • Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
  • 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).

You may not qualify if:

  • Subject has a history of more than two lumbar spine surgeries.
  • Subject requires additional lumbar surgery or surgery of any type prior to Day 75.
  • Subject had disc fusion at any level in the most recent surgery.
  • 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.
  • 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.
  • Subject has used systemic corticosteroids within 2 months of the Screening Visit.
  • 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.
  • 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.
  • 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.
  • Subject has a serious psychosocial co-morbidity.
  • Subject has a history of drug or alcohol abuse within one year prior to screening.
  • Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
  • Subject consumes an average of \> 100 mg oral Morphine Sulfate equivalents per day during the 10 day run-in period.
  • Standard deviation around the mean of the average pain intensity scores during the 10 day run-in period is \> 2.0.
  • Subject has a Body Mass Index (BMI) \> 38 kg/m2.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

AOC-Research

Birmingham, Alabama, 35209, United States

Location

Hope Research

Phoenix, Arizona, 85018, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

Rockford Orthopedic

Rockford, Illinois, 61114, United States

Location

Hope Research_Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Tarheel Clinical Research

Raliegh, North Carolina, 27612, United States

Location

Upstate Clinical

Spartanburg, South Carolina, 29303, United States

Location

Danville Orthopedic

Danville, Virginia, 24541, United States

Location

Results Point of Contact

Title
Heather Vander Ploeg
Organization
Regenesis Biomedical Inc.
Heather.VanderPloeg@regenesisbio.com
602-428-7041

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 15, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 9, 2017

Results First Posted

February 9, 2017

Record last verified: 2016-12

Locations

US(8)