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

NCT02902796 | Unknown Phase 2

• 1 other identifier: IIR-2016-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• NPRS

  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 Outcomes (3)

• Oswestry Disability Index

  3 weeks, and 4 days

• Patients Global Impression of Change

  3 weeks, and 4 days

• Preferability Survey

  3, and 6 months; at the completion of each treatment groups.

Study Arms (2)

Treatment group A

ACTIVE COMPARATOR

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

Treatment group B

ACTIVE COMPARATOR

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

Interventions

Spinal cord stimulator DEVICE

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.

Treatment group A; Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Clinical Research, Winston-Salem, NC: lead

Study Sites (1)

Jason Hong

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (13)

• Simpson BA. Spinal cord stimulation. Br J Neurosurg. 1997 Feb;11(1):5-11. doi: 10.1080/02688699746627. No abstract available.

  PMID: 9156011 BACKGROUND

• De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord stimulation: toward paresthesia-free pain suppression. Neurosurgery. 2010 May;66(5):986-90. doi: 10.1227/01.NEU.0000368153.44883.B3.

  PMID: 20404705 BACKGROUND

• De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.

  PMID: 23321375 BACKGROUND

• Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014 Jul;17(5):443-50. doi: 10.1111/ner.12197. Epub 2014 Jun 19.

  PMID: 24945621 BACKGROUND

• De Ridder D, Vancamp T, Lenders MW, De Vos CC, Vanneste S. Is preoperative pain duration important in spinal cord stimulation? A comparison between tonic and burst stimulation. Neuromodulation. 2015 Jan;18(1):13-7; discussion 17. doi: 10.1111/ner.12253. Epub 2014 Oct 21.

  PMID: 25334057 BACKGROUND

• Kriek N, Groeneweg G, Huygen FJ. Burst Spinal Cord Stimulation in a Patient with Complex Regional Pain Syndrome: A 2-year Follow-Up. Pain Pract. 2015 Jul;15(6):E59-64. doi: 10.1111/papr.12295. Epub 2015 Apr 10.

  PMID: 25858033 BACKGROUND

• Crosby ND, Goodman Keiser MD, Smith JR, Zeeman ME, Winkelstein BA. Stimulation parameters define the effectiveness of burst spinal cord stimulation in a rat model of neuropathic pain. Neuromodulation. 2015 Jan;18(1):1-8; discussion 8. doi: 10.1111/ner.12221. Epub 2014 Aug 21.

  PMID: 25145400 BACKGROUND

• Van Havenbergh T, Vancamp T, Van Looy P, Vanneste S, De Ridder D. Spinal cord stimulation for the treatment of chronic back pain patients: 500-Hz vs. 1000-Hz burst stimulation. Neuromodulation. 2015 Jan;18(1):9-12; discussion 12. doi: 10.1111/ner.12252. Epub 2014 Oct 22.

  PMID: 25339436 BACKGROUND

• de Vos CC, Bom MJ, Vanneste S, Lenders MW, de Ridder D. Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation. 2014 Feb;17(2):152-9. doi: 10.1111/ner.12116. Epub 2013 Sep 24.

  PMID: 24655043 BACKGROUND

• De Ridder D, Lenders MW, De Vos CC, Dijkstra-Scholten C, Wolters R, Vancamp T, Van Looy P, Van Havenbergh T, Vanneste S. A 2-center comparative study on tonic versus burst spinal cord stimulation: amount of responders and amount of pain suppression. Clin J Pain. 2015 May;31(5):433-7. doi: 10.1097/AJP.0000000000000129.

  PMID: 24977394 BACKGROUND

• Kriek N, Groeneweg JG, Stronks DL, Huygen FJ. Comparison of tonic spinal cord stimulation, high-frequency and burst stimulation in patients with complex regional pain syndrome: a double-blind, randomised placebo controlled trial. BMC Musculoskelet Disord. 2015 Aug 25;16:222. doi: 10.1186/s12891-015-0650-y.

  PMID: 26303326 BACKGROUND

• Ito S, Sugiura T, Azami T, Sasano H, Sobue K. Spinal cord stimulation for a woman with complex regional pain syndrome who wished to get pregnant. J Anesth. 2013 Feb;27(1):124-7. doi: 10.1007/s00540-012-1462-y. Epub 2012 Aug 15.

  PMID: 23011119 BACKGROUND

• Yoo HS, Nahm FS, Yim KH, Moon JY, Kim YS, Lee PB. Pregnancy in woman with spinal cord stimulator for complex regional pain syndrome: a case report and review of the literature. Korean J Pain. 2010 Dec;23(4):266-9. doi: 10.3344/kjp.2010.23.4.266. Epub 2010 Dec 1.

  PMID: 21217892 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James North, MD

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)