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

NCT02265848 | Completed Phase 4 Results DMC

• 1 other identifier: IIR-2014-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Low Back Pain; Radiculopathy; Complex Regional Pain Syndrome (CRPS)

Keywords

Spinal cord stimulation; Chronic pain; Chronic low back pain; Radiculopathy; Complex Regional Pain Syndrome (CRPS); High Frequency stimulation

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  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.

  Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)

Secondary Outcomes (2)

• Oswestry Disability Index Questionnaire (ODI).

  Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)

• Patient's Global Impression of Change (PGIC)

  Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)

Other Outcomes (1)

• Preferability

  End of treatment visit on visit 4

Study Arms (2)

Treatment group A

ACTIVE COMPARATOR

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; Other: Low frequency stimulation

Treatment group B

ACTIVE COMPARATOR

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; Other: Low frequency stimulation

Interventions

High frequency stimulation OTHER

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.

Treatment group A; Treatment group B

Low frequency stimulation OTHER

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.

Treatment group A; Treatment group B

Eligibility Criteria

• Age: 18 Years - 70 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 70 years of age.
• Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
• Subject pain scores \>5 on NPRS

You may not qualify if:

• Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
• Unstable medical or psychiatric illness
• 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)

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (19)

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  PMID: 9156011 BACKGROUND

• Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29.

  PMID: 21528381 BACKGROUND

• Kemler MA, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnee CA, van den Wildenberg FA. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000 Aug 31;343(9):618-24. doi: 10.1056/NEJM200008313430904.

  PMID: 10965008 BACKGROUND

• Gordon AT, Zou SP, Kim Y, Gharibo C. Challenges to setting spinal cord stimulator parameters during intraoperative testing: factors affecting coverage of low back and leg pain. Neuromodulation. 2007 Apr;10(2):133-41. doi: 10.1111/j.1525-1403.2007.00101.x.

  PMID: 22151862 BACKGROUND

• Wu M, Linderoth B, Foreman RD. Putative mechanisms behind effects of spinal cord stimulation on vascular diseases: a review of experimental studies. Auton Neurosci. 2008 Feb 29;138(1-2):9-23. doi: 10.1016/j.autneu.2007.11.001.

  PMID: 18083639 BACKGROUND

• Fisher LE, Tyler DJ, Triolo RJ. Optimization of selective stimulation parameters for multi-contact electrodes. J Neuroeng Rehabil. 2013 Feb 27;10:25. doi: 10.1186/1743-0003-10-25.

  PMID: 23442372 BACKGROUND

• Guan Y, Wacnik PW, Yang F, Carteret AF, Chung CY, Meyer RA, Raja SN. Spinal cord stimulation-induced analgesia: electrical stimulation of dorsal column and dorsal roots attenuates dorsal horn neuronal excitability in neuropathic rats. Anesthesiology. 2010 Dec;113(6):1392-405. doi: 10.1097/ALN.0b013e3181fcd95c.

  PMID: 21068658 BACKGROUND

• El-Khoury C, Hawwa N, Baliki M, Atweh SF, Jabbur SJ, Saade NE. Attenuation of neuropathic pain by segmental and supraspinal activation of the dorsal column system in awake rats. Neuroscience. 2002;112(3):541-53. doi: 10.1016/s0306-4522(02)00111-2.

  PMID: 12074897 BACKGROUND

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  PMID: 9414060 BACKGROUND

• Cui JG, Meyerson BA, Sollevi A, Linderoth B. Effect of spinal cord stimulation on tactile hypersensitivity in mononeuropathic rats is potentiated by simultaneous GABA(B) and adenosine receptor activation. Neurosci Lett. 1998 May 15;247(2-3):183-6. doi: 10.1016/s0304-3940(98)00324-3.

  PMID: 9655623 BACKGROUND

• Song Z, Meyerson BA, Linderoth B. The interaction between antidepressant drugs and the pain-relieving effect of spinal cord stimulation in a rat model of neuropathy. Anesth Analg. 2011 Nov;113(5):1260-5. doi: 10.1213/ANE.0b013e3182288851. Epub 2011 Jul 25.

  PMID: 21788322 BACKGROUND

• Song Z, Meyerson BA, Linderoth B. Spinal 5-HT receptors that contribute to the pain-relieving effects of spinal cord stimulation in a rat model of neuropathy. Pain. 2011 Jul;152(7):1666-1673. doi: 10.1016/j.pain.2011.03.012. Epub 2011 Apr 22.

  PMID: 21514998 BACKGROUND

• Ding X, Hua F, Sutherly K, Ardell JL, Williams CA. C2 spinal cord stimulation induces dynorphin release from rat T4 spinal cord: potential modulation of myocardial ischemia-sensitive neurons. Am J Physiol Regul Integr Comp Physiol. 2008 Nov;295(5):R1519-28. doi: 10.1152/ajpregu.00899.2007. Epub 2008 Aug 27.

  PMID: 18753268 BACKGROUND

• Smits H, van Kleef M, Joosten EA. Spinal cord stimulation of dorsal columns in a rat model of neuropathic pain: evidence for a segmental spinal mechanism of pain relief. Pain. 2012 Jan;153(1):177-183. doi: 10.1016/j.pain.2011.10.015. Epub 2011 Nov 9.

  PMID: 22078661 BACKGROUND

• Prager JP. What does the mechanism of spinal cord stimulation tell us about complex regional pain syndrome? Pain Med. 2010 Aug;11(8):1278-83. doi: 10.1111/j.1526-4637.2010.00915.x.

  PMID: 20704677 BACKGROUND

• Buonocore M, Bodini A, Demartini L, Bonezzi C. Inhibition of somatosensory evoked potentials during spinal cord stimulation and its possible role in the comprehension of antalgic mechanisms of neurostimulation for neuropathic pain. Minerva Anestesiol. 2012 Mar;78(3):297-302.

  PMID: 22095108 BACKGROUND

• Parker JL, Karantonis DM, Single PS, Obradovic M, Cousins MJ. Compound action potentials recorded in the human spinal cord during neurostimulation for pain relief. Pain. 2012 Mar;153(3):593-601. doi: 10.1016/j.pain.2011.11.023. Epub 2011 Dec 19.

  PMID: 22188868 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; Low Back Pain; Radiculopathy; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Limitations and Caveats

This study was limited by the sampling size, and by device type. Study was open to subjects who were implanted with Boston Scientific's Precision Plus device only

Results Point of Contact

• Title: Dr. James North MD
• Organization: Center for Clinical Research / Carolinas Pain Institute

jhong@ccrpain.com

3367656181

Study Officials

• James M North, MD

  The Carolinas Pain Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 16, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 25, 2016
• Results First Posted: November 11, 2015

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)