Lumbar SurgeryNCT02416973

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

A study testing Provant in people with Lumbar Surgery, run by Regenesis Biomedical, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Lumbar Surgery
What is being tested?: Provant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 8 sitesUnited States
Study dates: Mar 2015to Aug 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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.

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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.
Subject is currently pregnant or planning on becoming pregnant prior to Day 75.
Subject has been previously treated with the PROVANT Therapy System.
Subject is in current litigation regarding back pain or is receiving Worker's Compensation.
Subject is unwilling or unable to follow study instructions, comply with the treatment regimen, study visits, and ePRO assessments.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

AOC-Research
Birmingham, Alabama, 35209
Injury Care Research
Boise, Idaho, 83713
Danville Orthopedic
Danville, Virginia, 24541
Hope Research_Las Vegas
Las Vegas, Nevada, 89106
Hope Research
Phoenix, Arizona, 85018
Tarheel Clinical Research
Raliegh, North Carolina, 27612
Rockford Orthopedic
Rockford, Illinois, 61114
Upstate Clinical
Spartanburg, South Carolina, 29303

Other trials in United States

About this study

Conditions: Lumbar Surgery
Being tested: Provant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProvantDevice

Study groups in NCT02416973
Study group	Role	What they receive
Sham of Provant	Other	Sham of Provant Receives: Device: Provant
Active Treatment	Other	Active Provant Treatment Receives: Device: Provant
Active Treatment with alternative settings	Other	Active Provant Treatment with alternative settings Receives: Device: Provant

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Aug 2016

First posted15 Apr 2015 (estimated)
Study startMar 2015
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02416973
Sponsor's protocol ID: RBI.2015.001
Status last verified: Dec 2016
First submitted: 30 Mar 2015
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lumbar Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery
ClinicalTrials.gov ID: NCT02416973
Acronym / sponsor ID: RBI.2015.001
Conditions: Lumbar Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 15 Apr 2015 (estimated)
Results: Posted 9 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Sham of Provant	Other	Device: ProvantSham of Provant
Active Treatment	Other	Device: ProvantActive Provant Treatment
Active Treatment with alternative settings	Other	Device: ProvantActive Provant Treatment with alternative settings

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Provant	Device	Active Treatment, Active Treatment with alternative settings, Sham of Provant

Primary outcome

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).

Results and safety

Results posted to the registry on 9 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham of Provant	14	13
Active Treatment	13	10
Active Treatment With Alternative Settings	14	13

Primary outcome: Percent Change From Baseline in Pain Scores

Time frame: 60 days. Mean (Standard Deviation). Unit: Percent Difference

Measure	Sham of Provant n = 13	Active Treatment n = 9	Active Treatment With Alternative Settings n = 13
Value	-25.6 (24.81)	-40.2 (26.35)	-18.6 (39.47)

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham of Provant	0 of 14 (0%)	5 of 14 (35.7%)	Not reported
Active Treatment	0 of 13 (0%)	6 of 13 (46.2%)	Not reported
Active Treatment With Alternative Settings	0 of 14 (0%)	3 of 14 (21.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Surgery

RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Not yet recruiting
Comparing Long-Acting Local Pain Relief Methods in PLIF Surgery
Posterior Lumbar Interbody Fusion (PLIF), Postoperative Analgesia After Disc Surgery
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Provant in people with Lumbar Surgery, run by Regenesis Biomedical, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Pain Scores (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02416973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.