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High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System (HFSCS)

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ClinicalTrials.gov Identifier: NCT02265848
Recruitment Status : Completed
First Posted : October 16, 2014
Results First Posted : November 11, 2015
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
The Center for Clinical Research, Winston-Salem, NC

Brief Summary:
Study designed to compare the conventional stimulation programming versus the high frequency stimulation programming of the spinal cord stimulator for subjects who already have a spinal cord stimulator.

Condition or disease Intervention/treatment Phase
Chronic Pain Low Back Pain Radiculopathy Complex Regional Pain Syndrome (CRPS) Other: High frequency stimulation Other: Low frequency stimulation Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Blinded, Randomized Control Trial of High Frequency Stimulation in Subjects With Precision® Spinal Cord Stimulator System to Assess Efficacy and Preferability in Back and Extremity Pain Relief
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment group A
Subjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
Other: High frequency stimulation
Implanted pulse generator of a spinal cord stimulator will programmed to deliver high frequency stimulation for pain relief. For our purposes, high frequency stimulation will be defined as 1000 hertz.

Other: Low frequency stimulation
Implanted pulse generator of a spinal cord stimulator will programmed to deliver low frequency stimulation for pain relief. Low frequency stimulation will be defined as conventional stimulation pulse generator programming.

Active Comparator: Treatment group B
Subjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
Other: High frequency stimulation
Implanted pulse generator of a spinal cord stimulator will programmed to deliver high frequency stimulation for pain relief. For our purposes, high frequency stimulation will be defined as 1000 hertz.

Other: Low frequency stimulation
Implanted pulse generator of a spinal cord stimulator will programmed to deliver low frequency stimulation for pain relief. Low frequency stimulation will be defined as conventional stimulation pulse generator programming.




Primary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) ]
    Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.


Secondary Outcome Measures :
  1. Oswestry Disability Index Questionnaire (ODI). [ Time Frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) ]
    ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.

  2. Patient's Global Impression of Change (PGIC) [ Time Frame: Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4) ]
    PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.


Other Outcome Measures:
  1. Preferability [ Time Frame: End of treatment visit on visit 4 ]
    At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must be 18 years and older, and younger than 70 years of age.
  2. Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
  3. Subject pain scores >5 on NPRS

Exclusion Criteria:

  1. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
  2. Unstable medical or psychiatric illness
  3. Lifetime history of psychosis, hypomania, or mania.
  4. Epilepsy, or dementia
  5. Substance abuse in the last 6 months
  6. Pregnant or breastfeeding
  7. Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
  8. Treatment with investigational drug within 30 days of screening.
  9. Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines

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): NCT02265848


Locations
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United States, North Carolina
Center for Clinical Research
Winston Salem, North Carolina, United States, 27103
Sponsors and Collaborators
The Center for Clinical Research, Winston-Salem, NC
Investigators
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Principal Investigator: James M North, MD The Carolinas Pain Institute

Publications:

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Responsible Party: The Center for Clinical Research, Winston-Salem, NC
ClinicalTrials.gov Identifier: NCT02265848     History of Changes
Other Study ID Numbers: IIR-2014-01
First Posted: October 16, 2014    Key Record Dates
Results First Posted: November 11, 2015
Last Update Posted: October 25, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participants data will be shared with anyone other than study staff for analysis purposes.
Keywords provided by The Center for Clinical Research, Winston-Salem, NC:
Spinal cord stimulation
Chronic pain
Chronic low back pain
Radiculopathy
Complex Regional Pain Syndrome (CRPS)
High Frequency stimulation
Additional relevant MeSH terms:
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Radiculopathy
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autonomic Nervous System Diseases