scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Control Group ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background: Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.Method：Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥ 5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), achievement rate of a desirable pain state (VAS score ≤ 4), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Discussion：The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registration: NCT03858790, clinicaltrials.gov, registered on March 1st, 2019, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03858790

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Control Group ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain. Method Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥ 5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), achievement rate of a desirable pain state (VAS score ≤ 4), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Discussion The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Controlled Trial ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.Method Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the spinal cord stimulation group (experimental group, EG) will undergo continuous stimulation. The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline in the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle.Discussion The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Controlled Trial ◽  
Control Group ◽  
Withdrawal Period ◽  
Limb Pain ◽  
Primary Analysis ◽  
Vas Score

Abstract Background Although effective results of many studies support the use of spinal cord stimulation in chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain. Method Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average visual analog scale (VAS) score ≥ 5 will undergo a spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-month follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre- and post-randomization), and 6 months. The primary outcome is the difference of maximal VAS score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1-, 3-, and 6-month follow-ups; responder rate (VAS score improving by 50%); achievement rate of a desirable pain state (VAS score ≤ 4); awake times during sleep; Beck Depression Inventory for depression evaluation; short-form 36 for quality of life evaluation; drug usage; and satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Discussion The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain. Trial registration ClinicalTrials.gov NCT03858790. Registered on March 1, 2019, retrospectively registered

Burst Spinal Cord Stimulation

Neurosurgery ◽  
2010 ◽  
Vol 66 (5) ◽  
pp. 986-990 ◽  
Author(s):  
Dirk De Ridder ◽  
Sven Vanneste ◽  
Mark Plazier ◽  
Elsa van der Loo ◽  
Tomas Menovsky
Keyword(s):  
Spinal Cord ◽  
Neuropathic Pain ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Short Form ◽  
Burst Stimulation ◽  
Analog Scale ◽  
Tonic Stimulation ◽  
Better Than

Abstract INTRODUCTION Spinal cord stimulation is commonly used for neuropathic pain modulation. The major side effect is the onset of paresthesia. The authors describe a new stimulation design that suppresses pain as well as, or even better than, the currently used stimulation, but without creating paresthesia. METHODS A spinal cord electrode (Lamitrode) for neuropathic pain was implanted in 12 patients via laminectomy: 4 at the C2 level and 7 at the T8–T9 level for cervicobrachialgia and lumboischialgia, respectively (1 at T11 at another center). During external stimulation, the patients received the classic tonic stimulation (40 or 50 Hz) and the new burst stimulation (40-Hz burst with 5 spikes at 500 Hz per burst). RESULTS Pain scores were measured using a visual analog scale and the McGill Short Form preoperatively and during tonic and burst stimulation. Paresthesia was scored as present or not present. Burst stimulation was significantly better for pain suppression, by both the visual analog scale score and the McGill Short Form score. Paresthesia was present in 92% of patients during tonic stimulation, and in only 17% during burst stimulation. Average follow-up was 20.5 months. CONCLUSION The authors present a new method of spinal cord stimulation using bursts that suppress neuropathic pain without the mandatory paresthesia. Pain suppression seems as good as or potentially better than that achieved with the currently used stimulation. Average follow-up after nearly 2 years (20.5 months) suggests that this stimulation design is stable.

scholarly journals High-frequency (10 kHz) spinal cord stimulation for the treatment of focal, chronic postsurgical neuropathic pain: results from a prospective study in Belgium

2021 ◽  
Author(s):  
Bart Billet ◽  
Karel Hanssens ◽  
Olivier De Coster ◽  
Angela Santos ◽  
Anand Rotte ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Analog Scale ◽  
Clinical Trial Registration ◽  
Chronic Postsurgical Pain ◽  
Average Pain ◽  
Complication Of Surgery ◽  
A Prospective Study

Aim: Chronic postsurgical pain (CPSP) is a common complication of surgery. This study was conducted to evaluate the efficacy and safety of paresthesia-free, 10-kHz spinal cord stimulation (SCS) as a treatment for CPSP. Patients & methods: Subjects in this prospective, single-arm study had an average pain intensity of ≥5 cm on a 10-cm visual analog scale. The subjects who had pain relief of ≥50% (response) with temporary trial stimulation were permanently implanted with 10-kHz SCS and assessed for 1 year. Results: At 12 months, 94% of subjects were responders to 10-kHz SCS, and 88% had pain remission (visual analog scale ≤2.5 cm). Conclusion: The pain relief was durable in CPSP subjects and the safety profile of 10-kHz SCS was as expected. Clinical trial registration: VT005076953 (Privacy Commission of Belgium)

Back Pain: A Real Target for Spinal Cord Stimulation?

Neurosurgery ◽  
2011 ◽  
Vol 70 (3) ◽  
pp. 574-585 ◽  
Author(s):  
Philippe Rigoard ◽  
Alexandre Delmotte ◽  
Samuel D'Houtaud ◽  
Lorraine Misbert ◽  
Bakari Diallo ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Back Pain ◽  
Pain Relief ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Analog Scale ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
Pain Visual Analog Scale

Abstract Background: Failed back surgery syndrome represents one of the most frequent etiologies of chronic back pain and is a major public health issue. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS) systems. New-generation leads using several columns of stimulation can generate longitudinal and/or transverse stimulation fields into the spinal cord. Objective: To investigate, through extensive stimulation testing, the capacity of multicolumn tripolar leads to achieve back territory paresthesia coverage in refractory failed back surgery syndrome patients. Methods: Eleven patients implanted with a 16-contact spinal cord stimulation lead (Specify 5-6-5, Medtronic Inc) were assessed with a systematic exploration of 43 selected stimulation configurations to generate bilateral back paresthesia in addition to leg territory coverage. Results: The tripolar lead successfully generated paresthesia in both bilateral back and leg territories in 9 patients (81.8%). Success rates of multicolumn stimulation patterns were significantly higher than for longitudinal configurations for lombodorsal paresthesia coverage. Six months after implantation, significant pain relief was obtained compared with preoperative evaluation for global pain (Visual Analog Scale, 2.25 vs 8.2 preoperatively; P < .05), leg pain (Visual Analog Scale, 0.5 vs 7.6 preoperatively; P < .05), and back pain (Visual Analog Scale, 1.5 vs 7.8 preoperatively; P < .05). Conclusion: These results suggest that multicolumn leads can reliably generate back pain coverage and favor pain relief outcomes. This may lead physicians to reconsider new indications for spinal cord stimulation. Expanding neurostimulation perspectives to intractable back pain syndromes could become realistic in the near future.

scholarly journals Successful application of burst spinal cord stimulation for refractory upper limb pain: a case series

2021 ◽  
Vol 49 (3) ◽  
pp. 030006052110040
Author(s):  
Kuen Su Lee ◽  
Yoo Kyung Jang ◽  
Gene Hyun Park ◽  
In Jae Jun ◽  
Jae Chul Koh
Keyword(s):  
Spinal Cord ◽  
Upper Limb ◽  
Spinal Cord Stimulation ◽  
Therapeutic Potential ◽  
Case Series ◽  
Limb Amputation ◽  
Intractable Pain ◽  
Limb Pain ◽  
Cord Injury ◽  
Upper Limb Pain

Spinal cord stimulation (SCS) has been used to treat sustained pain that is intractable despite various types of treatment. However, conventional tonic waveform SCS has not shown promising outcomes for spinal cord injury (SCI) or postamputation pain. The pain signal mechanisms of burst waveforms are different to those of conventional tonic waveforms, but few reports have presented the therapeutic potential of burst waveforms for the abovementioned indications. This current case report describes two patients with refractory upper limb pain after SCI and upper limb amputation that were treated with burst waveform SCS. While the patients could not obtain sufficient therapeutic effect with conventional tonic waveforms, the burst waveforms provided better pain reduction with less discomfort. However, further studies are necessary to better clarify the mechanisms and efficacy of burst waveform SCS in patients with intractable pain.

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