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. 2021 Dec 2;12(12):CD013756.
doi: 10.1002/14651858.CD013756.pub2.

Implanted spinal neuromodulation interventions for chronic pain in adults

Neil E O'Connell  1 , Michael C Ferraro  2   3 , William Gibson  4 , Andrew Sc Rice  5 , Lene Vase  6 , Doug Coyle  7   8 , Christopher Eccleston  9
Affiliations

Implanted spinal neuromodulation interventions for chronic pain in adults

Neil E O'Connell et al. Cochrane Database Syst Rev. .

Abstract

Background: Implanted spinal neuromodulation (SNMD) techniques are used in the treatment of refractory chronic pain. They involve the implantation of electrodes around the spinal cord (spinal cord stimulation (SCS)) or dorsal root ganglion (dorsal root ganglion stimulation (DRGS)), and a pulse generator unit under the skin. Electrical stimulation is then used with the aim of reducing pain intensity.

Objectives: To evaluate the efficacy, effectiveness, adverse events, and cost-effectiveness of implanted spinal neuromodulation interventions for people with chronic pain.

Search methods: We searched CENTRAL, MEDLINE Ovid, Embase Ovid, Web of Science (ISI), Health Technology Assessments, ClinicalTrials.gov and World Health Organization International Clinical Trials Registry from inception to September 2021 without language restrictions, searched the reference lists of included studies and contacted experts in the field.

Selection criteria: We included randomised controlled trials (RCTs) comparing SNMD interventions with placebo (sham) stimulation, no treatment or usual care; or comparing SNMD interventions + another treatment versus that treatment alone. We included participants ≥ 18 years old with non-cancer and non-ischaemic pain of longer than three months duration. Primary outcomes were pain intensity and adverse events. Secondary outcomes were disability, analgesic medication use, health-related quality of life (HRQoL) and health economic outcomes.

Data collection and analysis: Two review authors independently screened database searches to determine inclusion, extracted data and evaluated risk of bias for prespecified results using the Risk of Bias 2.0 tool. Outcomes were evaluated at short- (≤ one month), medium- four to eight months) and long-term (≥12 months). Where possible we conducted meta-analyses. We used the GRADE system to assess the certainty of evidence.

Main results: We included 15 unique published studies that randomised 908 participants, and 20 unique ongoing studies. All studies evaluated SCS. We found no eligible published studies of DRGS and no studies comparing SCS with no treatment or usual care. We rated all results evaluated as being at high risk of bias overall. For all comparisons and outcomes where we found evidence, we graded the certainty of the evidence as low or very low, downgraded due to limitations of studies, imprecision and in some cases, inconsistency. Active stimulation versus placebo SCS versus placebo (sham) Results were only available at short-term follow-up for this comparison. Pain intensity Six studies (N = 164) demonstrated a small effect in favour of SCS at short-term follow-up (0 to 100 scale, higher scores = worse pain, mean difference (MD) -8.73, 95% confidence interval (CI) -15.67 to -1.78, very low certainty). The point estimate falls below our predetermined threshold for a clinically important effect (≥10 points). No studies reported the proportion of participants experiencing 30% or 50% pain relief for this comparison. Adverse events (AEs) The quality and inconsistency of adverse event reporting in these studies precluded formal analysis. Active stimulation + other intervention versus other intervention alone SCS + other intervention versus other intervention alone (open-label studies) Pain intensity Mean difference Three studies (N = 303) demonstrated a potentially clinically important mean difference in favour of SCS of -37.41 at short term (95% CI -46.39 to -28.42, very low certainty), and medium-term follow-up (5 studies, 635 participants, MD -31.22 95% CI -47.34 to -15.10 low-certainty), and no clear evidence for an effect of SCS at long-term follow-up (1 study, 44 participants, MD -7 (95% CI -24.76 to 10.76, very low-certainty). Proportion of participants reporting ≥50% pain relief We found an effect in favour of SCS at short-term (2 studies, N = 249, RR 15.90, 95% CI 6.70 to 37.74, I2 0% ; risk difference (RD) 0.65 (95% CI 0.57 to 0.74, very low certainty), medium term (5 studies, N = 597, RR 7.08, 95 %CI 3.40 to 14.71, I2 = 43%; RD 0.43, 95% CI 0.14 to 0.73, low-certainty evidence), and long term (1 study, N = 87, RR 15.15, 95% CI 2.11 to 108.91 ; RD 0.35, 95% CI 0.2 to 0.49, very low certainty) follow-up. Adverse events (AEs) Device related No studies specifically reported device-related adverse events at short-term follow-up. At medium-term follow-up, the incidence of lead failure/displacement (3 studies N = 330) ranged from 0.9 to 14% (RD 0.04, 95% CI -0.04 to 0.11, I2 64%, very low certainty). The incidence of infection (4 studies, N = 548) ranged from 3 to 7% (RD 0.04, 95%CI 0.01, 0.07, I2 0%, very low certainty). The incidence of reoperation/reimplantation (4 studies, N =5 48) ranged from 2% to 31% (RD 0.11, 95% CI 0.02 to 0.21, I2 86%, very low certainty). One study (N = 44) reported a 55% incidence of lead failure/displacement (RD 0.55, 95% CI 0.35, 0 to 75, very low certainty), and a 94% incidence of reoperation/reimplantation (RD 0.94, 95% CI 0.80 to 1.07, very low certainty) at five-year follow-up. No studies provided data on infection rates at long-term follow-up. We found reports of some serious adverse events as a result of the intervention. These included autonomic neuropathy, prolonged hospitalisation, prolonged monoparesis, pulmonary oedema, wound infection, device extrusion and one death resulting from subdural haematoma. Other No studies reported the incidence of other adverse events at short-term follow-up. We found no clear evidence of a difference in otherAEs at medium-term (2 studies, N = 278, RD -0.05, 95% CI -0.16 to 0.06, I2 0%) or long term (1 study, N = 100, RD -0.17, 95% CI -0.37 to 0.02) follow-up. Very limited evidence suggested that SCS increases healthcare costs. It was not clear whether SCS was cost-effective.

Authors' conclusions: We found very low-certainty evidence that SCS may not provide clinically important benefits on pain intensity compared to placebo stimulation. We found low- to very low-certainty evidence that SNMD interventions may provide clinically important benefits for pain intensity when added to conventional medical management or physical therapy. SCS is associated with complications including infection, electrode lead failure/migration and a need for reoperation/re-implantation. The level of certainty regarding the size of those risks is very low. SNMD may lead to serious adverse events, including death. We found no evidence to support or refute the use of DRGS for chronic pain.

Trial registration: ClinicalTrials.gov NCT01750229 NCT01486108 NCT01726751 NCT01400282 NCT01697358 NCT03228420 NCT01162993 NCT03957395 NCT00200122 NCT00351208 NCT03462147 NCT03718325 NCT03858790 NCT04479787 NCT03470766 NCT03546738 NCT03733886 NCT04039633 NCT04676022 NCT04894734 NCT03595241 NCT03419312 NCT03740763 NCT03680846 NCT03312010.

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Conflict of interest statement

NOC: none known.

MF: none known

WG: none known.

ASCR: ASCR is an Hon. Consultant in Pain Medicine at Chelsea and Westminster Hospital NHS Foundation Trust and is an employee of Imperial College London. He works in a multi‐disciplinary pain service, providing specialist diagnostic and management service for people living with chronic neuropathic pain. ASCR undertakes consultancy and advisory board work for Imperial College Consultants; in the last 36 months this has included remunerated work for: Pharmanovo, Lateral, Novartis, Pharmaleads, Mundipharma, Orion, Toray, Abide, Confo, Vertex, Shanghai SIMR Biotech, Asahi Kasei & Theranexis (since 2020 fees have been donated to charity). ASCR was the owner of share options in Spinifex Pharmaceuticals, from which personal benefit accrued between 2015 and 2019 upon the acquisition of Spinifex by Novartis. ASCR is named as an inventor on patents (not being pursued):

  1. Rice ASC, Vandevoorde S, Lambert D.M (2005), Methods using N‐(2‐propenyl)hexadecanamide and related amides to relieve pain. WO2005/079771;

  2. Okuse K, et al (2013). Methods of treating pain by inhibition of VGF activity. EP13702262.0/ WO2013 110945.

ASRC is a member of the UK Joint Committee on Vaccination and Immunisation, Varicella sub‐committee, the Neurology, Pain & Psychiatry Expert Advisory Group, Commission on Human Medicines, Medicines & Healthcare Products Regulatory Agency (MHRA) and the Public‐Private Partnership for Analgesic Clinical Trial Translation, Innovations, Opportunities, and Networks (ACTTION) Executive Committee.

LV: none known.

DC: none known.

CE: none known.

Since NOC is an author and PaPaS Co‐ordinating Editor (as was CE at the time of developing the protocol), we acknowledge the input of Peter Tugwell, Senior Editor of the Cochrane Musculoskeletal, Oral, Skin, and Sensory (MOSS) Network, who acted as Sign‐off Editor for this review. NOC and CE had no input into the editorial decisions or processes for this review.

Figures

1
1
1.1
1.1. Analysis
Comparison 1: SCS vs sham, Outcome 1: Pain Intensity: average post‐intervention. Short‐term follow up. Mean difference
1.2
1.2. Analysis
Comparison 1: SCS vs sham, Outcome 2: Disability: short‐term follow‐up
1.3
1.3. Analysis
Comparison 1: SCS vs sham, Outcome 3: HR‐QoL: short‐term follow‐up
2.1
2.1. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 1: Pain intensity: average post‐intervention. Short‐term follow‐up. Mean Difference
2.2
2.2. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 2: Pain: participants with ≥50% pain relief. Short‐term follow‐up. Risk Ratio
2.3
2.3. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 3: Pain intensity: average post‐intervention. Medium‐term follow‐up. Mean difference
2.4
2.4. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 4: Pain: participants with ≥50% pain relief. Medium‐term follow‐up. Risk Ratio
2.5
2.5. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 5: Pain intensity: average post‐intervention. Long‐term follow‐up. Mean difference
2.6
2.6. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 6: Pain: participants with ≥50% pain relief. Long‐term follow‐up. Risk Ratio
2.7
2.7. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 7: Adverse events: electrode/lead failure or displacement. Medium‐term follow‐up
2.8
2.8. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 8: Adverse events: electrode/lead failure or displacement. Long‐term follow‐up
2.9
2.9. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 9: Adverse events: infection. Medium‐term follow‐up
2.10
2.10. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 10: Adverse events: need for repeated implantation procedures. Medium‐term follow‐up
2.11
2.11. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 11: Adverse events: need for repeated implantation procedures. Long‐term follow‐up
2.12
2.12. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 12: Adverse events: other. Medium‐term follow‐up
2.13
2.13. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 13: Adverse events: other. Long‐term follow‐up
2.14
2.14. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 14: Disability (Oswestry Disabiility Index). Medium‐term follow‐up
2.15
2.15. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 15: Health‐Related Quality of Life. Short‐term follow‐up
2.16
2.16. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 16: Health‐Related Quality of Life. Medium‐term follow‐up
2.17
2.17. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 17: Health‐Related Quality of Life. Long‐term follow‐up
2.18
2.18. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 18: Medication use: participants using medication. Medium‐term follow‐up
2.19
2.19. Analysis
Comparison 2: SCS + other intervention vs other intervention, Outcome 19: Medication use: morphine oral equivalent daily (mg). Medium‐term follow‐up
See this image and copyright information in PMC

Comment in

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van Beek 2015 {published data only}
    1. Beek M, Slangen R, Schaper NC, Faber C G, Joosten E A, Dirksen CD, Dongen RT, et al.Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24-month follow-up of a prospective two-center randomized controlled trial. Diabetes Care 2015;38(9):e132‐4. - PubMed
Winfree 2005 {published data only}
    1. Winfree CJ.Spinal cord stimulation for the relief of chronic pain. Current Surgery 2005;62(5):476‐81. - PubMed
Wolter 2012 {published data only}
    1. Wolter T, Kiemen A, Porzelius C, Kaube H.Effects of sub-perception threshold spinal cord stimulation in neuropathic pain: a randomized controlled double-blind crossover study. European Journal of Pain 2012;16(5):648‐55. - PubMed

References to studies awaiting assessment

Miller 2015 {published data only}
    1. Miller N, Sebahar M, Vallejo R, Binyamin R, Lin S, Mekel-Bobrov N.Optimization of stimulation location is essential to sub-perception SCS: results of a double-blind randomized placebo-controlled trial. In: Neuromodulation. Vol. 18. 2015:e99.
Miller 2016 {published data only}
    1. Miller J, Sweet JA, Badjatiya A, Tan D.Paresthesia-free high-density SCS for postlaminectomy syndrome in a pre-screened population: A prospective, randomized, placebo-controlled study. In: Neuromodulation. Vol. 19 (3). 2016:e29. - PubMed

References to ongoing studies

ACTRN12620000720910 {published data only}
    1. An evaluation of spinal cord stimulation for the treatment of chronic pain, also its effect on mood, sleep, physical activity and analgesic medicine requirements.. Ongoing study. 03/08/20. Contact author for more information.
Burst SCS {published data only}
    1. Burst Spinal Cord Stimulation (Burst-SCS) study. Ongoing study. 12/03/2019. Contact author for more information.
ChiCTR‐IOR‐17012289 {published data only}
    1. A randomized controlled study of spinal cord electrical stimulation in the treatment of pain in patients with diabetic foot. Ongoing study. 03/08/2020. Contact author for more information.
CITRIP {published data only}
    1. Lu Y, Mao P, Wang G, Tao W, Xiong D, Ma K, et al.Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study). Trials 2020;21(1):834. - PMC - PubMed
DISTINCT {published data only}
    1. Moeschler S, Yue J, Schultz D, Deer T, Desai M, Falowski S, et al.DISTINCT: RCT toevaluate BurstDRTM vs medical management for low back pain. In: Neuromodulation. Vol. 24. 2021:e155.
DRKS00022557 {published data only}
    1. Effect of stimulation frequency in dorsal root ganglion stimulation (DRG Stimulation). Ongoing study. 01/04/2021. Contact author for more information.
ISRCTN10663814 {published data only}
    1. Comparison of spinal cord stimulation in combination with standard pain treatment versus standard pain treatment only in patients with intractable chronic back pain without previous history of spine surgery. Ongoing study. 01/01/2020. Contact author for more information.
MODULATE‐ LBP {published data only}
    1. Al-Kaisy A, Royds J, Palmisani S, Pang D, Wesley S, Taylor R, et al.Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol. Trials 2020;21:1-13. - PMC - PubMed
NCT03546738 {published data only}
    1. Spinal cord Burst stimulation for chronic radicular pain following lumbar spine surgery: a randomized double-blind sham-controlled crossover trial. Ongoing study. 05/09/2018. Contact author for more information.
NCT03733886 {published data only}
    1. A randomised sham-controlled double-blinded study of burst spinal cord stimulation for chronic peripheral neuropathic pain. Ongoing study. 07/11/2018. Contact author for more information.
NCT04039633 {published data only}
    1. Spinal cord stimulation for refractory pain in erythromelalgia. Ongoing study. 26/09/2019. Contact author for more information.
NCT04676022 {published data only}
    1. SCS as an option for chronic low back and/or leg pain instead of surgery (SOLIS). Ongoing study. 26/03/2021. Contact author for more information.
NCT04894734 {published data only}
    1. Spinal cord stimulation (SCS) forsSpinal cord injury (SCI) . Ongoing study. 31/05/2021. Contact author for more information.
PANACEA {published data only}
    1. Prospective, randomised, crossover, controlled, feasibility study to assess the efficacy of BurstDR spinal cord stimulation (SCS) as a treatment for persistent abdominal refractory visceral pain secondary to chronic pancreatitis: trial. Ongoing study. 09/07/2018. Contact author for more information.
PARS‐trial {published data only}DRKS00018929
    1. Ahmadi R, Campos B, Hajiabadi MM, Doerr-Harim C, Tenckhoff S, Rasche D, et al.Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial.. Trials 2021;22(1):87. - PMC - PubMed
PENTAGONS {published data only}ISRCTN40062191
    1. Diabetic peripheral neuropathy treatment with dorsal root ganglion stimulation – the trial. Ongoing study. 13/06/2018. Contact author for more information.
PET‐SCS {published data only}
    1. PET patterns, biomarkers and outcome in treated FBSS patients (). Ongoing study. 11/02/2018. Contact author for more information.
SCS‐PHYSIO {published data only}
    1. Treatment of neuropathic pain with spinal cord stimulation and physiotherapy for more effective pain relief, increased physical activity and improved health related quality of life. Ongoing study. 109/05/2018. Contact author for more information.
SENZA‐NSRBP {published data only}87648175
    1. Al-Kaisy A, Eldridge P, Crossman J, Kallewaard JW, Elzinga L, Shiban E, et al.Medical management versus 10 khz spinal cord stimulation and medical management for the treatment of non-surgical back pain. In: Pain physician. Vol. 21. 2018:E229.
    1. Al-Kaisy A, Eldridge PR, Crossman J, Kallewaard JW, Elzinga LL, Shiban EES, et al.Medical management and 10 kHz spinal cord stimulation for the treatment of non-surgical back pain. In: Neuromodulation. Vol. 21. 2018:3: E138.
    1. Patel N, Calodney A, Kapural L, Province-Azalde R, Lad SP, Pilitsis J, et al.high-frequency spinal cord stimulation at 10 kHz for the treatment of nonsurgical refractory back pain: design of a pragmatic, multicenter, randomized controlled trial. Pain Practice 2021;21(2):171-83. - PMC - PubMed
    1. Reiters P, Al-Kaisy A, Eldridge P, Shiban E, Crossman J, Fritz A K, et al.High Frequency Spinal Cord Stimulation (HFSCS) at 10 kHz plus Conventional Medical Management (CMM) versus conventional medical management alone for the treatment of non-surgical back pain. In: Neuromodulation. Vol. 22. 2019:e8.
TSUNAMI DRG {published data only}
    1. A European, prospective, multi-center, double-blind, randomized, controlled, clinical trial investigating the effects of high frequency wireless spinal cord stimulation (SCS) over exiting nerve roots in the treatment of chronic back pain. Ongoing study. 01/03/2018. Contact author for more information.

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References to other published versions of this review

O'Connell 2020
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Publication types

Associated data