High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients

NCT03318172 | Terminated FDA Device

• 1 other identifier: 1703-133-841
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore which mode is effective in the management of intractable chronic pain, the high-density stimulation or the conventional stimulation, in patients who undergo SCS implantation after successful pre-implantation SCS trial.

Conditions

Pain, Intractable

Keywords

Spinal Cord Stimulation; High Density Stimulation

Outcome Measures

Primary Outcomes (1)

• Percentage of high density SCS mode selected by participants

  Patients will be questioned about the more effective mode of pain relief between conventional and high density stimulation.

  Four weeks after randomization

Secondary Outcomes (19)

• Difference of pain intensity between the baseline screening and the evaluation at each visit

  Six month from baseline screening

• Change of pain characteristics between the baseline screening and the evaluation at each visit

  Six month from baseline screening

• The ability in daily living

  Screening and follow up at 1 month, 3 months and 6 months

• The current pain intensity and interference status

  Screening and follow up at 1 month, 3 months and 6 months

• Subjective sleep quality

  Screening and follow up at 1 month, 3 months and 6 months

Study Arms (2)

Group C spinal cord stimulator

EXPERIMENTAL

Spinal cord stimulator (SCS) implantation with conventional stimulation mode therapy during 2 weeks followed by 2 weeks with high-density stimulation mode therapy.

Device: Spinal Cord Stimulator

Group H spinal cord stimulator

ACTIVE COMPARATOR

Spinal cord stimulator (SCS) implantation with high-density stimulation mode therapy during 2 weeks followed by 2 weeks with conventional stimulation mode therapy.

Device: Spinal Cord Stimulator

Interventions

Spinal Cord Stimulator DEVICE

Implantation of spinal cord stimulator in patients included in the study and divided in conventional and high density stimulation groups

Also known as: Conventional stimulation mode, High density stimulation mode

Group C spinal cord stimulator; Group H spinal cord stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic intractable pain who meets the Korean SCS Reimbursement Guideline as follows:
• (Korea SCS Reimbursement Guideline)
• An ineffective patient with sustainable severe intractable pain (VAS or NRS pain score over 7 grade) who has been treated by a conservative therapy (medication and nerve block, etc.) for 6 months. cf.) CRPS is available after the conservative therapy for 3 months
• An ineffective cancer pain patient with over 1-year life expectancy and VAS (or NRS pain score) over 7 grade who takes active pain treatment for 6 months such as medication, nerve block, epidural morphine injection, etc.
• Age \> 18
• Patients who have been informed of the study procedures and has given written informed consent.
• Patients who are willing to comply with study protocol including attending the study visits

You may not qualify if:

• Expected inability of patients to receive or properly operate the SCS system
• Active malignancy
• Addiction to any of the following drugs, alcohol, and/or medication
• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
• Local infection or other skin disorder at site of incision
• Pregnancy
• Other implanted active medical device
• Life expectancy \< 1 year
• Coagulation deficiency (Platelet count \< 100,000, PT INR \> 1.4)
• Immune deficiency (HIV positive, immunosuppressive, etc.)

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (11)

• Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967 Jul-Aug;46(4):489-91. No abstract available.

  PMID: 4952225 BACKGROUND

• North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-106; discussion 106-7. doi: 10.1227/01.neu.0000144839.65524.e0.

  PMID: 15617591 BACKGROUND

• Kumar K, Buchser E, Linderoth B, Meglio M, Van Buyten JP. Avoiding complications from spinal cord stimulation: practical recommendations from an international panel of experts. Neuromodulation. 2007 Jan;10(1):24-33. doi: 10.1111/j.1525-1403.2007.00084.x.

  PMID: 22151809 BACKGROUND

• Cruccu G, Aziz TZ, Garcia-Larrea L, Hansson P, Jensen TS, Lefaucheur JP, Simpson BA, Taylor RS. EFNS guidelines on neurostimulation therapy for neuropathic pain. Eur J Neurol. 2007 Sep;14(9):952-70. doi: 10.1111/j.1468-1331.2007.01916.x.

  PMID: 17718686 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

• Meyerson BA, Linderoth B. Mechanisms of spinal cord stimulation in neuropathic pain. Neurol Res. 2000 Apr;22(3):285-92. doi: 10.1080/01616412.2000.11740672.

  PMID: 10769822 BACKGROUND

• Wolter T. Spinal cord stimulation for neuropathic pain: current perspectives. J Pain Res. 2014 Nov 18;7:651-63. doi: 10.2147/JPR.S37589. eCollection 2014.

  PMID: 25429237 BACKGROUND

• Kuechmann C, Valine T,Wolfe D. Could automatic position-adaptive stimulation be useful in spinal cord stimulation? Eur J Pain 2009;13:S243.

  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

• Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014 Mar;15(3):347-54. doi: 10.1111/pme.12294. Epub 2013 Dec 5.

  PMID: 24308759 BACKGROUND

• Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.

  PMID: 23425338 BACKGROUND

MeSH Terms

Conditions

Pain, Intractable

Condition Hierarchy (Ancestors)

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

Study Officials

• Jee Y Moon, PhD

  Clinical Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The day of the SCS implantation (RestoreSensor Surescan MRI Neurostimulator, Medtronic ©) the patients are randomized based on a random number assigned from www.randomization.com. The random number table is sent to the MedTronic representative in charge of the SCS mode control by the operating nurse who has no information about the study protocol. At this time, implantation practitioners and other research participants don't know which group is assigned first. Subjects with SCS implantation will be assigned 1:1 to either group C (conventional stimulation) or H (High-Density stimulation) to find an effective mode of pain relief.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: V1 SCS trial for 6 days (3d conventional + 3d HD stimulation). V2 Enrolled if positive response (≥50% pain reduction) in one of the two modes during V1 + informed consent and randomization + blinding * Group C Conventional mode (2 weeks) + HD mode (2 weeks) * Groups H HD mode (2 weeks) + conventional mode (2 weeks) V3 After 2 weeks (+3d allowed) from V2. Cross-over performed by the MedTronics person in charge of adjusting the SCS mode. Mode-related information will not be shared with other researchers V4 (unblinding) 2 weeks from V3 (+3d allowed). Patients will be questioned about the more effective mode (primary endpoint). The SCS will be programmed accordingly V5 (follow-up 1) 4 weeks after V4 (±5d). Short-term assessment of effectiveness and safety V6 (follow-up 2) 12 weeks after V4 (±5d). Middle-term assessment of effectiveness and safety V7 (follow-up 3) 24 weeks after V4 (±5d). Long-term assessment of effectiveness and safety

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 23, 2017
• Study Start: July 14, 2017
• Primary Completion: March 22, 2018
• Study Completion: April 12, 2018
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)