Comparison of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Pain Relief

January 29, 2019 updated by: The Center for Clinical Research, Winston-Salem, NC

Randomized Controlled Cross Over Study to Compare the Efficacy of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Axial Pain Relief

A randomized controlled with cross over study compares efficacy of burst stimulation, 1000 hertz stimulation, and standard stimulation in an non-superiority trial. The study duration is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with approximately 4 days of wash off in between.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study will enroll 22 patients for the purpose of evaluation of efficacy of burst stimulation, 1000 hertz frequency stimulation or standard stimulation in patients who have a spinal cord stimulators implanted. Each patients will be randomized to either group A or B, where each groups consists of Burst, standard, and 1000 hertz frequency stimulation or vice versa with wash off period in between. The duration for each stimulation modes will be approximately 3 weeks, with approximately 4 days of wash off prior to starting the new stimulation mode and in between stimulation modes. Treatment duration for each groups will last about 3 months or less, and with cross over total duration of the study is about 6 months in total.

During the trial there will be 13 visits. The first visit will consist of screening visit activities and once the eligibility of the subjects are confirmed, they will be randomized and they can start the study immediately and begin their wash off period. After the initial visit/ randomization visit, there will be 12 follow up visits. At each visit, patients will be assessed for their pain, disability index, and their perception of their painful condition, as well as any adverse events and changes of medication usage or lack there of. At the end of the study, the data will be pooled to look at the pain level, disability index, and patients perceived changes in their painful condition for each treatment groups (Burst stimulation, 1000 hertz stimulation and standard stimulation) to determine if subject experienced equivocal pain relief from all three stimulation modes.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Jason Hong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be 18 years and older, and younger than 75 years of age.
  • Subject has had a Precision Spectra, or Plus spinal cord stimulator system implanted for chronic painful condition.
  • Subject continues to receive adequate pain relief with greater than or equal to 50% pain relief based on pre-trial and pre-implant pain assessment.
  • Device age should not be less than 2 months old.
  • Subject is willing to comply with all requirements of the study.

Exclusion Criteria:

  • Subjects who are getting <50% pain relief on current SCS based on pre-trial and pre-implant pain assessment.
  • Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
  • Unstable medical or psychiatric illness
  • Urine drug screen shows controlled substance/s not prescribed by the prescribers.
  • Lifetime history of psychosis, hypomania, or mania.
  • Epilepsy, or dementia
  • Substance abuse in the last 6 months
  • Pregnant or breastfeeding
  • Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
  • Treatment with investigational drug within 30 days of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group A
Group A will consist of sequence of treatment with 3 stimulation modes. They are, in order, 1000 hertz, standard, and burst stimulation. Each stimulation modes will last 3 weeks, with 4 days of wash off between them. Each group treatments will take about 3 months, and subject will cross over into the other treatment group. Burst stimulation sends packets of electrical pulses, composed of pulse and packet frequency. 1000 hertz stimulation delivers tonic, sub perception stimulation. The standard stimulation mode, which will serve as the control, will be below 100 hertz, and its pulse strength will be above threshold, where patients will feel the tingling from the electrical pulses generated by the spinal cord stimulator.
Device: Spinal cord stimulator
Spinal cord stimulator will be programmed to deliver, according to the randomization status of the patient, burst, 1000 hertz, and standard stimulation during each treatment group.
Active Comparator: Treatment group B
Group B will consist of sequence of treatment with 3 stimulation modes. They are, in order, burst stimulation, standard, and 1000 hertz. Each stimulation modes will last 3 weeks, with 4 days of wash off between them. Each group treatments will take about 3 months, and subject will cross over into the other treatment group. Burst stimulation sends packets of electrical pulses, composed of pulse and packet frequency. 1000 hertz stimulation delivers tonic, sub perception stimulation. The standard stimulation mode, which will serve as the control, will be below 100 hertz, and its pulse strength will be above threshold, where patients will feel the tingling from the electrical pulses generated by the spinal cord stimulator.
Device: Spinal cord stimulator
Spinal cord stimulator will be programmed to deliver, according to the randomization status of the patient, burst, 1000 hertz, and standard stimulation during each treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPRS
Time Frame: 3 weeks, and 4 days
Pain rating on 10 point digital scale for average, best, worst, during last week, and current pain level to be collected at each follow up visits. Collected data for each stimulation modes will be compared against each other to assess efficacy of 1000 hertz, and burst stimulation against each other and against the standard stimulation to look for differences in pain rating among three stimulation modes. Data comparison will occur at the end of the study, which is expected to last about 6 months.
3 weeks, and 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 3 weeks, and 4 days
Set of questionnaires designed to assess the level of disability in chronic pain patients. Each patients will be assessed with this questionnaires at each follow up visits. Collected data for each stimulation modes will be compared against each other to assess effects of 1000 hertz, and burst stimulation against each other and against the standard stimulation on Oswestry Disability Index, and changes if any.
3 weeks, and 4 days
Patients Global Impression of Change
Time Frame: 3 weeks, and 4 days
Patient's assessment of the improvement or worsening of their painful condition during the study, and these will be collected at each follow up visits. Collected data for each stimulation modes will be compared against each other to assess effects of 1000 hertz, and burst stimulation against each other and against the standard stimulation on PGIC scores, and changes if any.
3 weeks, and 4 days
Preferability Survey
Time Frame: 3, and 6 months; at the completion of each treatment groups.
subject preference of one stimulation program out of 3 received
3, and 6 months; at the completion of each treatment groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Clinical Research, Winston-Salem, NC

Investigators

  • Principal Investigator: James North, MD, The Center for Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual data will be shared. Only the pooled data will be shared with public and at the scientific meetings.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Spinal cord stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe