Pain, IntractableNCT03318172
High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients
A study testing Spinal Cord Stimulator in people with Pain, Intractable, run by Seoul National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable
- What is being tested?
- Spinal Cord Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2017to 12 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients: A Prospective Multicenter Randomized Controlled, Double-blind, Crossover Exploratory Study With 6-m Open Follow-up
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.
Read the detailed description
Since its introduction in 1967 (1), spinal cord stimulation (SCS) has become a well-established modality for the treatment of chronic neuropathic back and leg pain, including postlaminectomy syndrome, complex regional pain syndrome, ext. (2-5) The mechanism of action remains poorly understood but is thought to involve a combination of local neural inhibition, excitation of nearby axons, changes in neurotransmitter physiology, and jamming of pathological network activity by masking intrinsic patterns of neural activity (6). It is generally agreed that a sensory percept (paresthesia) covering the region of pain is required in order to achieve maximal effectiveness (3,7), and as a result, conventional SCS settings typically consist of intermediate frequencies (40-60 Hz), relatively long pulse width (300-500 μsec), and amplitude high enough to induce a sensory percept in the distribution of the patient's pain (2,3,5). However, paresthesia can produce some degree of discomfort, particularly with changes in position and variability of activities (8). Consequently, sometimes there is a trade-off between pain relief and paresthesia discomfort, and the clinical benefits can be offset by the side-effects of the stimulation. Recent studies have attempted to deliver energy to the spinal cord below the threshold for paresthesia ("paresthesia-free" stimulation), with variable degrees of success in the control of neuropathic pain. For example, De Ridder et al. described "burst" stimulation (trains of five pulses) in 12 patients, resulting in paresthesia-free pain relief that was superior to conventional settings (9). In a multicenter prospective study, Al-Kaisy et al. evaluated 10 kHz SCS (HFSCS) delivered below the sensory threshold and documented a long-term reduction in the mean intensity of chronic back pain (10). However, a randomized, double-blind, placebo-controlled crossover study comparing 5 kHz high-frequency subthreshold stimulation to placebo found no significant difference between the two modalities, with a tendency for better results during the first treatment administered, which suggests a strong placebo effect (11). Another randomized controlled, double-blinded, crossover study showed that subthreshold stimulation had significantly lower pain relief than the conventional, supra-threshold SCS (12). Notably, both studies included participants treated with conventional stimulation parameters and did not perform a "trial" to confirm that the study population would, in fact, demonstrate a response to subthreshold stimulation. Most systematic studies of paresthesia-free stimulation employed a high rate of energy delivery (high-density [HD] stimulation) that either required the development of specialized hardware (9,10) or modification of existing systems to allow parameters outside of normal clinical use (11). However, it is possible that rechargeable stimulators currently in widespread use may be able to deliver sufficient energy to accomplish pain relief without paresthesia in appropriately selected patients. Additionally, response to subthreshold stimulation might be heterogeneous in unpredictable ways, which implies that there might be a subset of patients who respond to the therapy better than others.
- Conditions
- Pain, Intractable
- Being tested
- Spinal Cord Stimulator
- Keywords
- Spinal Cord Stimulation, High Density Stimulation
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulatorDevice
Also called Conventional stimulation mode, High density stimulation mode
Implantation of spinal cord stimulator in patients included in the study and divided in conventional and high density stimulation groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks after randomization
Secondary outcomes (19)
Difference of pain intensity between the baseline screening and the evaluation at each visit
Pain intensity will be evaluated using NRS (0-10) pain score
Measured: Six month from baseline screening
Change of pain characteristics between the baseline screening and the evaluation at each visit
The pain characteristics will be evaluated using PainDETECT
Measured: Six month from baseline screening
The ability in daily living
Measured by the Korean version of the Instrumental Activities of Daily Living (K-IADL) scale. The IADL require complex thinking skills, including organizational skills and they measure the ability of the person to live independently without the assistance of another person.
The IADL scale includes 8 categories labeled from A to H (A. Ability to Use Telephone, B. Shopping, C. Food preparation, D. Housekeeping, E. Laundry, F. Mode of transportation, G. Responsibility for Own Medication and H. Ability to Handle Finances). For each category, the patient should mark the description that resembles the highest functional level (either 0 or 1). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Measured: Screening and follow up at 1 month, 3 months and 6 months
The current pain intensity and interference status
The Brief Pain Inventory Short-Form (BPI-SF) scale measures the pain intensity (severity) and the impact of pain on functioning (interference). Includes a screening question about the pain on the day, pain drawing diagrams, four items about pain intensity (worst pain, least pain, average pain, pain right now), two items on pain relief treatment or medication, and one item on pain interference, with seven sub-items (general activity, mood, walking ability, normal walk, relations with other people, sleep, and enjoyment of life). Each item for pain severity is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score (0 to 40). The seven subitems of pain interference are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score (0 to 70). The first item, pain drawing diagrams and the items on pain relief treatment or medication do not contribute to the scoring.
Measured: Screening and follow up at 1 month, 3 months and 6 months
Subjective sleep quality
The difference of Insomnia Severity Index (ISI) between the baseline screening and the evaluation at 1 month, 3 months and 6 months follow up visits
Measured: Screening and follow up at 1 month, 3 months and 6 months
Oswestry Disability Index
The difference of Oswestry Disability Index between the baseline screening and the evaluation at 1 month, 3 months and 6 months follow up visits
Measured: Screening and follow up at 1 month, 3 months and 6 months
Beck Depression Inventory
The difference of Beck Depression Inventory between the baseline screening and the evaluation at 1 month, 3 months and 6 months follow up visits
Measured: Screening and follow up at 1 month, 3 months and 6 months
Pain Catastrophizing scale
Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event. The Pain Catastrophizing Scale (PCS) is a 13-item instrument derived from definitions of catastrophizing described in the literature. The PCS ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales from (0) not at all and (4) all the time. The PCS total score is computed by summing responses to all 13 items, total scores range from 0 - 52. The PCS subscales are computed as follows:
Rumination: Sum of items 8, 9, 10, 11 Magnification: Sum of items 6, 7, 13 Helplessness: Sum of items 1, 2, 3, 4, 5, 12 Total score <30= Negative and ≥30= Positive for catastrophizing
Measured: Screening and follow up at 1 month, 3 months and 6 months
The Connor-Davidson Resilience Scale (CD-RISC)
Resilience embodies the personal qualities that enable one to thrive in the face of adversity. The Connor-Davidson Resilience Scale (CD-RISC) contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all the time (4). The scale is rated based on how the subject has felt over the past month.
The total score ranges from 0-100, with higher scores reflecting greater resilience.
Measured: Screening and follow up at 1 month, 3 months and 6 months
Patient Global Impression of Change (PGIC)
The overall change in patient's pain for 6 months after the study unblinding, during the follow up visits
Measured: Follow up visits 1 month, 3 months and 6 months
Clinical Global Impressions-Improvement (CGI-I)
The overall change in patient's improvement for 6 months after the study unblinding, during the follow up visits
Measured: Follow up visits 1 month, 3 months and 6 months
Patient's satisfaction with the stimulation mode
The difference in the patient's satisfaction evaluated during the follow-up visits using a 5-point Likert scale (5: very satisfied, 4: somewhat satisfied, 3: Dissatisfied, 1: very unsatisfied)
Measured: Follow up visits 1 month, 3 months and 6 months
Any change of pain medication
The difference between the baseline screening and the evaluation at each visit
Measured: Six month from baseline screening
Pain area coverage by the SCS
The difference between crossover and follow-up visits (total of 5 times evaluation) by the patient drawing the area of pain coverage. The ideal treatment with SCS will be a total coverage of the pain area, however, sometimes the covered area does not perfectly match with the stimulated area (less or more area). Therefore, a simple drawing of a human body will be presented to the patients who will draw the area of pain and then the coverage of the SCS to compare and analyze the changes throughout the study.
Measured: Crossover and follow-up visits 1 month, 3 months and 6 months
Paresthesia threshold
The difference between the randomization, crossover and follow-up visits (total of 6 evaluation) by asking patient to indicate the threshold at which he or she experiences paresthesia. The SCS transmitter allows several intensity levels which are tested before setting the SCS mode. Usually, the intensity level is tested from lowest and slowly increased until the patient experience paresthesia. Paresthesia threshold is different from patient to patient and it might change along time. Therefore, the intensity level marked by the SCS transmitter where the patient experienced the paresthesia will be recorded to evaluate the changes during the study period.
Measured: Randomization, crossover and follow-up visits 1 month, 3 months and 6 months
Change in the overall SCS stimulation parameters
SCS stimulation parameters (active electrodes, frequency, pulse duration, amplitude and battery consumption) each visit after implantation. All parameters of SCS will be recorded in the same item as they are measured based on the SCS transmitter records and reflect the overall SCS status.
Measured: From week 1 (randomization) to 6 months follow-up visit
Battery efficiency of the neuro-stimulator
The battery usage will be measured by frequencies to recharge the battery during the follow-up visits.
Measured: Follow up visits 1 month, 3 months and 6 months
Adaptive Stim use
Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves) during the follow-up visits
Measured: Follow up visits 1 month, 3 months and 6 months
Measurement of adverse events
Any related adverse events throughout the whole study period (e.g. infection, hematoma, seroma, lead breakage, lead migration, SCS removal, etc).
Measured: Six month from baseline screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start14 Jul 2017
- Primary completion22 Mar 2018
- Study completion12 Apr 2018
Why it stopped: difficulty in recruting of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Y Moon, PhD, Principal investigator, Clinical Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318172
- Sponsor's protocol ID
- 1703-133-841
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2017
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 4952225North 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.
PubMed 15617591Kumar 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.
PubMed 22151809Cruccu 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.
PubMed 17718686Schu 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.
PubMed 24945621Meyerson 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.
PubMed 10769822Wolter 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.
PubMed 25429237Kuechmann C, Valine T,Wolfe D. Could automatic position-adaptive stimulation be useful in spinal cord stimulation? Eur J Pain 2009;13:S243.
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.
PubMed 20404705Al-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.
PubMed 24308759Perruchoud 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.
PubMed 23425338
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients: A Prospective Multicenter Randomized Controlled, Double-blind, Crossover Exploratory Study With 6-m Open Follow-up
- ClinicalTrials.gov ID
- NCT03318172
- Acronym / sponsor ID
- 1703-133-841
- Conditions
- Pain, Intractable
- Keywords
- Spinal Cord Stimulation, High Density Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruting of patients
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Since its introduction in 1967 (1), spinal cord stimulation (SCS) has become a well-established modality for the treatment of chronic neuropathic back and leg pain, including postlaminectomy syndrome, complex regional pain syndrome, ext. (2-5) The mechanism of action remains poorly understood but is thought to involve a combination of local neural inhibition, excitation of nearby axons, changes in neurotransmitter physiology, and jamming of pathological network activity by masking intrinsic patterns of neural activity (6). It is generally agreed that a sensory percept (paresthesia) covering the region of pain is required in order to achieve maximal effectiveness (3,7), and as a result, conventional SCS settings typically consist of intermediate frequencies (40-60 Hz), relatively long pulse width (300-500 μsec), and amplitude high enough to induce a sensory percept in the distribution of the patient's pain (2,3,5). However, paresthesia can produce some degree of discomfort, particularly with changes in position and variability of activities (8). Consequently, sometimes there is a trade-off between pain relief and paresthesia discomfort, and the clinical benefits can be offset by the side-effects of the stimulation. Recent studies have attempted to deliver energy to the spinal cord below the threshold for paresthesia ("paresthesia-free" stimulation), with variable degrees of success in the control of neuropathic pain. For example, De Ridder et al. described "burst" stimulation (trains of five pulses) in 12 patients, resulting in paresthesia-free pain relief that was superior to conventional settings (9). In a multicenter prospective study, Al-Kaisy et al. evaluated 10 kHz SCS (HFSCS) delivered below the sensory threshold and documented a long-term reduction in the mean intensity of chronic back pain (10). However, a randomized, double-blind, placebo-controlled crossover study comparing 5 kHz high-frequency subthreshold stimulation to placebo found no significant difference between the two modalities, with a tendency for better results during the first treatment administered, which suggests a strong placebo effect (11). Another randomized controlled, double-blinded, crossover study showed that subthreshold stimulation had significantly lower pain relief than the conventional, supra-threshold SCS (12). Notably, both studies included participants treated with conventional stimulation parameters and did not perform a "trial" to confirm that the study population would, in fact, demonstrate a response to subthreshold stimulation. Most systematic studies of paresthesia-free stimulation employed a high rate of energy delivery (high-density [HD] stimulation) that either required the development of specialized hardware (9,10) or modification of existing systems to allow parameters outside of normal clinical use (11). However, it is possible that rechargeable stimulators currently in widespread use may be able to deliver sufficient energy to accomplish pain relief without paresthesia in appropriately selected patients. Additionally, response to subthreshold stimulation might be heterogeneous in unpredictable ways, which implies that there might be a subset of patients who respond to the therapy better than others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group C spinal cord stimulator | Experimental | Device: Spinal Cord StimulatorSpinal cord stimulator (SCS) implantation with conventional stimulation mode therapy during 2 weeks followed by 2 weeks with high-density stimulation mode therapy. |
| Group H spinal cord stimulator | Active comparator | Device: Spinal Cord StimulatorSpinal cord stimulator (SCS) implantation with high-density stimulation mode therapy during 2 weeks followed by 2 weeks with conventional stimulation mode therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with chronic intractable pain who meets the Korean SCS Reimbursement Guideline as follows:
- (Korea SCS Reimbursement Guideline)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulatorAlso: Conventional stimulation mode, High density stimulation modeImplantation of spinal cord stimulator in patients included in the study and divided in conventional and high density stimulation groups | Device | Group C spinal cord stimulator, Group H spinal cord stimulator |
Primary outcome
Percentage of high density SCS mode selected by participants
Time frame: Four weeks after randomization
Patients will be questioned about the more effective mode of pain relief between conventional and high density stimulation.
19 secondary outcomes
Difference of pain intensity between the baseline screening and the evaluation at each visit
Time frame: Six month from baseline screening
Change of pain characteristics between the baseline screening and the evaluation at each visit
Time frame: Six month from baseline screening
The ability in daily living
Time frame: Screening and follow up at 1 month, 3 months and 6 months
The current pain intensity and interference status
Time frame: Screening and follow up at 1 month, 3 months and 6 months
Subjective sleep quality
Time frame: Screening and follow up at 1 month, 3 months and 6 months
Oswestry Disability Index
Time frame: Screening and follow up at 1 month, 3 months and 6 months
Beck Depression Inventory
Time frame: Screening and follow up at 1 month, 3 months and 6 months
Pain Catastrophizing scale
Time frame: Screening and follow up at 1 month, 3 months and 6 months
The Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Screening and follow up at 1 month, 3 months and 6 months
Patient Global Impression of Change (PGIC)
Time frame: Follow up visits 1 month, 3 months and 6 months
Clinical Global Impressions-Improvement (CGI-I)
Time frame: Follow up visits 1 month, 3 months and 6 months
Patient's satisfaction with the stimulation mode
Time frame: Follow up visits 1 month, 3 months and 6 months
Any change of pain medication
Time frame: Six month from baseline screening
Pain area coverage by the SCS
Time frame: Crossover and follow-up visits 1 month, 3 months and 6 months
Paresthesia threshold
Time frame: Randomization, crossover and follow-up visits 1 month, 3 months and 6 months
Change in the overall SCS stimulation parameters
Time frame: From week 1 (randomization) to 6 months follow-up visit
Battery efficiency of the neuro-stimulator
Time frame: Follow up visits 1 month, 3 months and 6 months
Adaptive Stim use
Time frame: Follow up visits 1 month, 3 months and 6 months
Measurement of adverse events
Time frame: Six month from baseline screening
Results and safety
The study was stopped early (reason given: difficulty in recruting of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 4952225Shealy 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.
- Background: PubMed 15617591North 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.
- Background: PubMed 22151809Kumar 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.
- Background: PubMed 17718686Cruccu 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.
- Background: PubMed 24945621Schu 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.
- Background: PubMed 10769822Meyerson 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.
- Background: PubMed 25429237Wolter 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.
- BackgroundKuechmann C, Valine T,Wolfe D. Could automatic position-adaptive stimulation be useful in spinal cord stimulation? Eur J Pain 2009;13:S243.
- Background: PubMed 20404705De 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.
- Background: PubMed 24308759Al-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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Y Moon, PhD principal investigator
Clinical Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulator in people with Pain, Intractable, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty in recruting of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of high density SCS mode selected by participants (time frame: Four weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318172, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.