Spinal cord stimulation for low back pain - PubMed (original) (raw)

Review

Spinal cord stimulation for low back pain

Adrian C Traeger et al. Cochrane Database Syst Rev. 2023.

Abstract

Background: Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals via implanted electrodes into the spinal cord. The long term benefits and harms of SCS for people with low back pain are uncertain.

Objectives: To assess the effects, including benefits and harms, of SCS for people with low back pain.

Search methods: On 10 June 2022, we searched CENTRAL, MEDLINE, Embase, and one other database for published trials. We also searched three clinical trials registers for ongoing trials.

Selection criteria: We included all randomised controlled trials and cross-over trials comparing SCS with placebo or no treatment for low back pain. The primary comparison was SCS versus placebo, at the longest time point measured in the trials. Major outcomes were mean low back pain intensity, function, health-related quality of life, global assessment of efficacy, withdrawals due to adverse events, adverse events, and serious adverse events. Our primary time point was long-term follow-up (≥ 12 months).

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 13 studies with 699 participants: 55% of participants were female; mean age ranged from 47 to 59 years; and all participants had chronic low back pain with mean duration of symptoms ranging from five to 12 years. Ten cross-over trials compared SCS with placebo. Three parallel-group trials assessed the addition of SCS to medical management. Most studies were at risk of performance and detection bias from inadequate blinding and selective reporting bias. The placebo-controlled trials had other important biases, including lack of accounting for period and carryover effects. Two of the three parallel trials assessing SCS as an addition to medical management were at risk of attrition bias, and all three had substantial cross-over to the SCS group for time points beyond six months. In the parallel-group trials, we considered the lack of placebo control to be an important source of bias. None of our included studies evaluated the impact of SCS on mean low back pain intensity in the long term (≥ 12 months). The studies most often assessed outcomes in the immediate term (less than one month). At six months, the only available evidence was from a single cross-over trial (50 participants). There was moderate-certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo. Pain was 61 points (on a 0- to 100-point scale, 0 = no pain) at six months with placebo, and 4 points better (8.2 points better to 0.2 points worse) with SCS. Function was 35.4 points (on a 0- to 100-point scale, 0 = no disability or best function) at six months with placebo, and 1.3 points better (3.9 points better to 1.3 points worse) with SCS. Health-related quality of life was 0.44 points out of 1 (0 to 1 index, 0 = worst quality of life) at six months with placebo, and 0.04 points better (0.16 points better to 0.08 points worse) with SCS. In that same study, nine participants (18%) experienced adverse events and four (8%) required revision surgery. Serious adverse events with SCS included infections, neurological damage, and lead migration requiring repeated surgery. We could not provide effect estimates of the relative risks as events were not reported for the placebo period. In parallel trials assessing SCS as an addition to medical management, it is uncertain whether, in the medium or long term, SCS can reduce low back pain, leg pain, or health-related quality of life, or if it increases the number of people reporting a 50% improvement or better, because the certainty of the evidence was very low. Low-certainty evidence suggests that adding SCS to medical management may slightly improve function and slightly reduce opioid use. In the medium term, mean function (0- to 100-point scale; lower is better) was 16.2 points better with the addition of SCS to medical management compared with medical management alone (95% confidence interval (CI) 19.4 points better to 13.0 points better; I2 = 95%; 3 studies, 430 participants; low-certainty evidence). The number of participants reporting opioid medicine use was 15% lower with the addition of SCS to medical management (95% CI 27% lower to 0% lower; I2 = 0%; 2 studies, 290 participants; low-certainty evidence). Adverse events with SCS were poorly reported but included infection and lead migration. One study found that, at 24 months, 13 of 42 people (31%) receiving SCS required revision surgery. It is uncertain to what extent the addition of SCS to medical management increases the risk of withdrawals due to adverse events, adverse events, or serious adverse events, because the certainty of the evidence was very low.

Authors' conclusions: Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention.

Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Conflict of interest statement

AT: provided paid consultancy on models of physiotherapy care to a health service provider in 2017. SG: none known IAH: employed by New South Wales (NSW) Ministry of Health, University of NSW, and Australian Orthopaedic Association, and received royalties for a 2016 book, Surgery, the Ultimate Placebo, and a 2021 book, Hippocrasy, How Doctors Are Betraying Their Oath. CGM: has received competitive grants from government agencies and industry to support his research. As an invited speaker at conferences, he has had his expenses covered and also received small gifts, such as a box of chocolates or a bottle of wine. He has received honoraria for marking theses, reviewing grants, and preparing talks.

Figures

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PRISMA study flow diagram

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Comparison 1: spinal cord stimulation versus placebo. Outcome 1.1: low back pain intensity (0‐100) at immediate‐term follow‐up (< 1 month)

5

5

Comparison 1: spinal cord stimulation versus placebo. Outcome 1.3: leg pain intensity (0‐100) at immediate‐term follow‐up (< 1 month)

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Comparison 2: spinal cord stimulation plus medical management versus medical management alone. Outcome 2.2: low back pain intensity at medium‐term follow‐up (≥ 3 months to < 12 months)

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Comparison 2: spinal cord stimulation plus medical management versus medical management alone. Outcome 2.4: leg pain intensity at medium‐term follow‐up (≥ 3 months to < 12 months)

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Comparison 2: spinal cord stimulation plus medical management versus medical management alone. Outcome 2.6: function at medium‐term follow‐up (≥ 3 months to < 12 months)

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Comparison 2: spinal cord stimulation plus medical management versus medical management alone. Outcome 2.7: health‐related quality of life at medium‐term follow‐up (≥ 3 months to < 12 months)

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Comparison 2: spinal cord stimulation plus medical management versus medical management alone. Outcome 2.8: global assessment of efficacy at medium‐term follow‐up (≥ 3 months to < 12 months)

1.1

1.1. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 1: Low back pain intensity (0‐100) at immediate‐term follow‐up (< 1 month)

1.2

1.2. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 2: Low back pain intensity (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

1.3

1.3. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 3: Leg pain intensity (0‐100) at immediate‐term follow‐up (< 1 month)

1.4

1.4. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 4: Leg pain intensity (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

1.5

1.5. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 5: Function (0‐100) at immediate‐term follow‐up (< 1 month)

1.6

1.6. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 6: Function (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

1.7

1.7. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 7: Health‐related quality of life (0‐1 index) at immediate‐term follow‐up (< 1 month)

1.8

1.8. Analysis

Comparison 1: Spinal cord stimulation (SCS) versus placebo, Outcome 8: Health‐related quality of life (0‐1 index) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.1

2.1. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 1: Low back pain intensity (0‐100) at short‐term follow‐up (≥ 1 mo to < 3 mo)

2.2

2.2. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 2: Low back pain intensity (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.3

2.3. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 3: Leg pain intensity (0‐100) at short‐term follow‐up (≥ 1 mo to < 3 mo)

2.4

2.4. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 4: Leg pain intensity (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.5

2.5. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 5: Function (0‐100) at short‐term follow‐up (≥ 1 mo to < 3 mo)

2.6

2.6. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 6: Function (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.7

2.7. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 7: Health‐related quality of life (0‐100) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.8

2.8. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 8: Global assessment of efficacy at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.9

2.9. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 9: Global assessment of efficacy at long‐term follow‐up (≥ 12 mo)

2.10

2.10. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 10: Withdrawals due to adverse events at longest follow‐up

2.11

2.11. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 11: Proportion with any adverse event at longest follow‐up

2.12

2.12. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 12: Proportion with serious adverse event at longest follow‐up

2.13

2.13. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 13: Medication use 1 (number (%) taking opioid medicines) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.14

2.14. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 14: Medication use 2 (daily MME) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

2.15

2.15. Analysis

Comparison 2: Spinal cord stimulation (SCS) plus medical management versus medical management alone, Outcome 15: Work status 1 (number returned to work) at medium‐term follow‐up (≥ 3 mo to < 12 mo)

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References

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Thomson 2017 {published data only}
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References to studies awaiting assessment

Mekel‐Bobrov 2017 {published data only}
    1. Mekel-Bobrov N, Rauck R, Maoz U. Differential mechanisms of action between paresthesia and paresthesia-free SCS: a PET study. Neuromodulation 2017;20:54. [DOI: 10.1111/ner.12572] - DOI
Miller 2015 {published data only}
    1. Miller NS, 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. Neuromodulation 2015;18:e13–e106. [DOI: 10.1111/ner.12277] - DOI
Miller 2016 {published data only}
    1. Miller JS, Badjatiya A, Tan D. Paresthesia-free high-density SCS for postlaminectomy syndrome in a pre-screened population: a prospective, randomized, placebo-controlled study (10079). Neuromodulation 2016;19:e1–e158. [DOI: 10.1111/ner.12428] - DOI - PubMed

References to ongoing studies

ACTRN12620000720910 {published data only}
    1. ACTRN12620000720910. An evaluation of spinal cord stimulation for the treatment of chronic pain, also its effect on mood, sleep, physical activity and analgesic medicine requirements. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379835&isReview=true (first registered 2 July 2020).
Ahmadi 2021 {published data only}
    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. [DOI: 10.1186/s13063-020-05013-7] - DOI - PMC - PubMed
Al‐Kaisy 2020 {published data only}
    1. Al-Kaisy A, Royds J, Palmisani S, Pang D, Wesley S, Taylor RS, 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):111. [DOI: 10.1186/s13063-019-3831-4] [URL: www.ncbi.nlm.nih.gov/pmc/articles/PMC6986091/pdf/13063_2019_Article_3831...] - DOI - PMC - PubMed
ISRCTN10663814 {published data only}
    1. ISRCTN10663814. 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. www.isrctn.com/ISRCTN10663814 (first posted 29 June 2020).
ISRCTN33292457 {published data only}
    1. ISRCTN33292457. Senza spinal cord stimulation system for the treatment of chronic back and leg pain in failed back surgery syndrome (FBSS) patients. www.isrctn.com/ISRCTN33292457 (first registered 08 April 2011). [DOI: 10.1186/ISRCTN33292457] - DOI
NCT03419312 {published data only}
    1. NCT03419312. PET patterns, biomarkers and outcome in burst SCS treated FBSS patients (PET-SCS). clinicaltrials.gov/ct2/show/NCT03419312 (first posted 1 February 2018).
NCT03462147 {published data only}
    1. NCT03462147. Efficacy of spinal cord stimulation in patients with a failed back surgery syndrome. clinicaltrials.gov/ct2/show/NCT03462147 (first posted 12 March 2018).
NCT03718325 {published data only}https://clinicaltrials.gov/show/NCT03718325
    1. NCT03718325. Burst spinal cord stimulation (Burst-SCS) study. clinicaltrials.gov/ct2/show/NCT03718325 (first posted 24 October 2018).
NCT03858790 {published data only}
    1. NCT03858790. Efficacy and safety of spinal cord stimulation in patients with chronic intractable pain. clinicaltrials.gov/ct2/show/NCT03858790 (first posted 1 March 2019).
NCT04479787 {published data only}
    1. NCT04479787. Spinal cord stimulation vs. medical management for low back pain (DISTINCT). clinicaltrials.gov/ct2/show/NCT04479787 (first posted 21 July 2020).
NCT04676022 {published data only}
    1. NCT04676022. SCS as an option for chronic low back and/or leg pain instead of surgery (SOLIS). clinicaltrials.gov/ct2/show/NCT04676022 (first posted 19 December 2020).
NCT04732325 {published data only}
    1. NCT04732325. Sensory testing of multiple forms of spinal cord stimulation for pain. clinicaltrials.gov/ct2/show/NCT04732325 (first posted 1 February 2021).
Reiter 2019 {published data only}
    1. Reiters P, Eldridge P, Shiban E, Crossman J, Fritz AK, Lehmberg J, 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. Neuromodulation 2019;22:e8. [URL: www.cochranelibrary.com/es/central/doi/10.1002/central/CN-02130554/refer...]

Additional references

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    1. Duarte RV, Nevitt S, McNicol E, Taylor RS, Buchser E, North RB, et al. Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain.. Pain 2020;161(1):24-35. [DOI: 10.1097/j.pain.0000000000001689] - DOI - PubMed
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