Review Articles|Articles in Press

Incidence of Lead Migration With Loss of Efficacy or Paresthesia Coverage After Spinal Cord Stimulator Implantation: Systematic Review and Proportional Meta-Analysis of Prospective Studies and Randomized Clinical Trials



      The objective of this meta-analysis was to approximate the incidence of overall lead migration, clinically significant lead migration, and asymptomatic lead migration in patients who have undergone spinal cord stimulator implantation.

      Materials and Methods

      A comprehensive literature search was performed for studies published before May 31, 2022. Only randomized controlled trials and prospective observational studies with more than ten patients were included. Two reviewers analyzed the articles from the literature search for final inclusion, after which, study characteristics and outcome data were extracted. The primary dichotomous categorical outcome variables were the incidence of overall lead migration, clinically significant lead migration (defined as lead migration resulting in loss of efficacy), and asymptomatic lead migration (defined as lead migration discovered incidentally on follow-up imaging) in patients with spinal cord stimulator implant. Freeman-Tukey arcsine square root transformation for meta-analysis of proportions using random effects (DerSimonian and Laird method) was used to calculate incidence rates for the outcome variables. Pooled incidence rates and 95% CIs were calculated for the outcome variables.


      Fifty-three studies met the inclusion criteria, with a total of 2932 patients having received spinal cord stimulator implants. The pooled incidence of overall lead migration was 9.97% (95% CI of 7.62%–12.59%). Only 24 of the included studies commented on the clinical significance of reported lead migrations, of which every lead migration was clinically significant. In these 24 studies, 96% of the reported lead migrations required a revision procedure or explant. Unfortunately, no studies that reported lead migration commented on asymptomatic lead migrations; therefore, the incidence of asymptomatic lead migrations could not be defined.


      This meta-analysis found that the rate of lead migration in patients who have received spinal cord stimulator implants is approximately one in ten patients. This likely closely approximates the incidence of clinically significant lead migration owing to the included studies not routinely performing follow-up imaging. Therefore, lead migrations were primarily discovered owing to loss of efficacy, and no included studies clearly reported asymptomatic lead migration. The results of this meta-analysis can be used to inform patients more accurately on the risks and benefits of spinal cord stimulator implantation.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Verrills P.
        • Sinclair C.
        • Barnard A.
        A review of spinal cord stimulation systems for chronic pain.
        J Pain Res. 2016; 9: 481-492
        • Jeon Y.H.
        Spinal cord stimulation in pain management: a review.
        Korean J Pain. 2012; 25: 143-150
        • Rock A.K.
        • Truong H.
        • Park Y.L.
        • Pilitsis J.G.
        Spinal cord stimulation.
        Neurosurg Clin N Am. 2019; 30: 169-194
        • Pollard E.M.
        • Lamer T.J.
        • Moeschler S.M.
        • et al.
        The effect of spinal cord stimulation on pain medication reduction in intractable spine and limb pain: a systematic review of randomized controlled trials and meta-analysis.
        J Pain Res. 2019; 12: 1311-1324
      1. Eckermann JM, Pilitsis JG, Vannaboutathong C, Wagner BJ, Province-Azalde R, Bendel MA. Systematic literature review of spinal cord stimulation in patients with chronic back pain without prior spine surgery. Neuromodulation. Published August 18, 2021.

        • D’Souza R.S.
        • Strand N.
        Neuromodulation with burst and tonic stimulation decreases opioid consumption: a post hoc analysis of the success using neuromodulation with BURST (SUNBURST) randomized controlled trial.
        Neuromodulation. 2021; 24: 135-141
        • D’Souza R.S.
        • Kubrova E.
        • Her Y.F.
        • et al.
        Dorsal root ganglion stimulation for lower extremity neuropathic pain syndromes: an evidence-based literature review.
        Adv Ther. 2022; 39: 4440-4473
        • D’Souza R.S.
        • Barman R.A.
        • Schappell J.B.
        • Hagedorn J.M.
        Does fibromyalgia affect the outcomes of spinal cord stimulation: an 11-year, multicenter, retrospective matched cohort study.
        Neuromodulation. 2023; 26: 206-214
        • Bates D.
        • Schultheis B.C.
        • Hanes M.C.
        • et al.
        A comprehensive algorithm for management of neuropathic pain.
        Pain Med. 2019; 20: S2-S12
        • Lee A.W.
        • Pilitsis J.G.
        Spinal cord stimulation: indications and outcomes.
        Neurosurg Focus. 2006; 21: E3
        • D'Souza R.S.
        • Barman R.
        • Joseph A.
        • Abd-Elsayed A.
        Evidence-based treatment of painful diabetic neuropathy: a systematic review.
        Curr Pain Headache Rep. 2022; 26: 583-594
        • Mehta V.
        • Poply K.
        • Ahmad A.
        • et al.
        Effectiveness of high dose spinal cord stimulation for non-surgical intractable lumbar radiculopathy-HIDENS Study.
        Pain Pract. 2022; 22: 233-247
        • D'Souza R.S.
        • Olatoye O.O.
        • Butler C.S.
        • Barman R.A.
        • Ashmore Z.M.
        • Hagedorn J.M.
        Adverse events associated with 10-kHz dorsal column spinal cord stimulation: a 5-year analysis of the manufacturer and user facility device experience (MAUDE) database.
        Clin J Pain. 2022; 38: 320-327
        • Dombovy-Johnson M.L.
        • D'Souza R.S.
        • Ha C.T.
        • Hagedorn J.M.
        Incidence and risk factors for spinal cord stimulator lead migration with or without loss of efficacy: a retrospective review of 91 consecutive thoracic lead implants.
        Neuromodulation. 2022; 25: 731-737
        • Hagedorn J.M.
        • Parmele J.B.
        • Wolff J.S.
        • Bendel M.A.
        • D'Souza R.S.
        The prevalence of elevated impedances and magnetic resonance imaging ineligibility following implantation of 10 kHz spinal cord stimulation devices: a retrospective review.
        Neuromodulation. 2022; 25: 719-723
      2. West T, Driver CN, D'Souza RS. Incidence of neuraxial and non-neuraxial hematoma complications from spinal cord stimulator surgery: systematic review and proportional meta-analysis. Neuromodulation. Published August 16, 2022.

      3. Hussain N, Karri J, Dimitrov T, et al. Incidence and predictors of inadvertent dural puncture after percutaneous spinal cord stimulation: a retrospective data base analysis. Neuromodulation. Published August 14, 2022.

        • D'Souza R.S.
        • Hunt C.L.
        A rare case of anchor fracture manifesting with new-onset neuropathic pain after spinal cord stimulator implantation.
        Neuromodulation. 2022; 25: 783-785
        • Hagedorn J.M.
        • Lam C.M.
        • D'Souza R.S.
        • et al.
        Explantation of 10 kHz spinal cord stimulation devices: a retrospective review of 744 patients followed for at least 12 months.
        Neuromodulation. 2021; 24: 499-506
        • Bendersky D.
        • Yampolsky C.
        Is spinal cord stimulation safe? A review of its complications.
        World Neurosurg. 2014; 82: 1359-1368
        • Babu R.
        • Hazzard M.A.
        • Huang K.T.
        • et al.
        Outcomes of percutaneous and paddle lead implantation for spinal cord stimulation: a comparative analysis of complications, reoperation rates, and health-care costs.
        Neuromodulation. 2013; 16 ([discussion: 426–417]): 418-426
        • North R.B.
        • Recinos V.R.
        • Attenello F.J.
        • Shipley J.
        • Long D.M.
        Prevention of percutaneous spinal cord stimulation electrode migration: a 15-year experience.
        Neuromodulation. 2014; 17: 670-677
        • Geurts J.W.
        • Smits H.
        • Kemler M.A.
        • Brunner F.
        • Kessels A.G.H.
        • van Kleef M.
        Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up.
        Neuromodulation. 2013; 16 ([discussion: 529]): 523-529
        • Sanderson J.E.
        • Ibrahim B.
        • Waterhouse D.
        • Palmer R.B.
        Spinal electrical stimulation for intractable angina-long-term clinical outcome and safety.
        Eur Heart J. 1994; 15: 810-814
        • Page M.J.
        • Shamseer L.
        • Tricco A.C.
        Registration of systematic reviews in PROSPERO: 30,000 records and counting.
        Syst Rev. 2018; 7: 32
        • Page M.J.
        • McKenzie J.E.
        • Bossuyt P.M.
        • et al.
        The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.
        BMJ. 2021; 372: n71
        • DerSimonian R.
        • Laird N.
        Meta-analysis in clinical trials.
        Control Clin Trials. 1986; 7: 177-188
        • Freeman M.F.
        • Tukey J.W.
        Transformations related to the angular and the square root.
        Ann Math Statist. 1950; 21: 607-611
        • Hagedorn J.M.
        • Romero J.
        • Ha C.T.
        • D'Souza R.S.
        Patient satisfaction with spinal cord stimulation and dorsal root ganglion stimulation for chronic intractable pain: a systematic review and meta-analysis.
        Neuromodulation. 2022; 25: 947-955
        • Al-Kaisy A.
        • Palmisani S.
        • Carganillo R.
        • et al.
        Safety and efficacy of 10 kHz spinal cord stimulation for the treatment of refractory chronic migraine: a prospective long-term open-label study.
        Neuromodulation. 2022; 25: 103-113
        • Al-Kaisy A.
        • Palmisani S.
        • Smith T.E.
        • et al.
        Long-term improvements in chronic axial low back pain patients without previous spinal surgery: a cohort analysis of 10-kHz high-frequency spinal cord stimulation over 36 months.
        Pain Med. 2018; 19: 1219-1226
        • Aló K.M.
        • Redko V.
        • Charnov J.
        Four year follow-up of dual electrode spinal cord stimulation for chronic pain.
        Neuromodulation. 2002; 5: 79-88
        • Amirdelfan K.
        • Vallejo R.
        • Benyamin R.
        • et al.
        High-frequency spinal cord stimulation at 10 kHz for the treatment of combined neck and arm pain: results from a prospective multicenter study.
        Neurosurgery. 2020; 87: 176-185
        • Andersen C.
        • Hole P.
        Long-term home treatment with epidural analgesia does not affect later spinal cord stimulation in patients with otherwise intractable angina pectoris.
        Clin J Pain. 1998; 14: 315-319
        • Arcioni R.
        • Palmisani S.
        • Mercieri M.
        • et al.
        Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: a prospective, open-label, exploratory study.
        Eur J Pain. 2016; 20: 70-78
        • Bolash R.
        • Creamer M.
        • Rauck R.
        • et al.
        Wireless high-frequency spinal cord stimulation (10 kHz) compared with multiwaveform low-frequency spinal cord stimulation in the management of chronic pain in failed back surgery syndrome subjects: preliminary results of a multicenter, prospective randomized controlled study.
        Pain Med. 2019; 20: 1971-1979
        • Bolash R.
        • Creamer M.
        • Rauck R.
        • et al.
        Multi-waveform spinal cord stimulation with high frequency electromagnetic coupled (HF-EMC) powered implanted electrode array and receiver for the treatment of chronic back and leg pain (SURF study).
        Pain Phys. 2022; 25: 67-76
        • Buffenoir K.
        • Rioult B.
        • Hamel O.
        • Labat J.J.
        • Riant T.
        • Robert R.
        Spinal cord stimulation of the conus medullaris for refractory pudendal neuralgia: a prospective study of 27 consecutive cases.
        Neurourol Urodyn. 2015; 34: 177-182
        • De Andres J.
        • Monsalve-Dolz V.
        • Fabregat-Cid G.
        • et al.
        Prospective, randomized blind effect-on-outcome study of conventional vs high-frequency spinal cord stimulation in patients with pain and disability due to failed back surgery syndrome.
        Pain Med. 2017; 18: 2401-2421
        • de Jongste M.J.
        • Nagelkerke D.
        • Hooyschuur C.M.
        • et al.
        Stimulation characteristics, complications, and efficacy of spinal cord stimulation systems in patients with refractory angina: a prospective feasibility study.
        Pacing Clin Electrophysiol. 1994; 17: 1751-1760
        • de Vos C.C.
        • Dijkstra C.
        • Lenders M.W.P.M.
        • Holsheimer J.
        Spinal cord stimulation with hybrid lead relieves pain in low back and legs.
        Neuromodulation. 2012; 15 ([discussion: 123]): 118-123
        • de Vos C.C.
        • Meier K.
        • Zaalberg P.B.
        • et al.
        Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial.
        Pain. 2014; 155: 2426-2431
        • Deer T.R.
        • Levy R.M.
        • Kramer J.
        • et al.
        Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial.
        Pain. 2017; 158: 669-681
        • Deer T.R.
        • Patterson D.G.
        • Baksh J.
        • et al.
        Novel intermittent dosing burst paradigm in spinal cord stimulation.
        Neuromodulation. 2021; 24: 566-573
        • Demartini L.
        • Terranova G.
        • Innamorato M.A.
        • et al.
        Comparison of Tonic vs. Burst Spinal Cord Stimulation during Trial Period.
        Neuromodulation. 2019; 22: 327-332
        • Di Pede F.
        • Lanza G.A.
        • Zuin G.
        • et al.
        Immediate and long-term clinical outcome after spinal cord stimulation for refractory stable angina pectoris.
        Am J Cardiol. 2003; 91: 951-955
        • Falowski S.M.
        • Sharan A.
        • McInerney J.
        • Jacobs D.
        • Venkatesan L.
        • Agnesi F.
        Nonawake vs awake placement of spinal cord stimulators: a prospective, multicenter study comparing safety and efficacy.
        Neurosurgery. 2019; 84: 198-205
        • Gatzinsky K.
        • Baardsen R.
        • Buschman H.P.
        Evaluation of the effectiveness of percutaneous octapolar leads in pain treatment with spinal cord stimulation of patients with failed back surgery syndrome during a 1-year follow-up: a prospective multicenter international study.
        Pain Pract. 2017; 17: 428-437
        • Horan M.
        • Jacobsen A.H.
        • Scherer C.
        • et al.
        Complications and effects of dorsal root ganglion stimulation in the treatment of chronic neuropathic pain: a nationwide cohort study in Denmark.
        Neuromodulation. 2021; 24: 729-737
        • Huygen F.J.P.M.
        • Liem L.
        • Nijhuis H.
        • Cusack W.
        • Kramer J.
        Evaluating dorsal root ganglion stimulation in a prospective Dutch cohort.
        Neuromodulation. 2019; 22: 80-86
        • Hwang R.
        • Field N.
        • Kumar V.
        • et al.
        Intraoperative neuromonitoring in percutaneous spinal cord stimulator placement.
        Neuromodulation. 2019; 22: 341-346
        • Im S.
        • Son B.C.
        Long-term changes in thecal sac compression and decreased cerebrospinal fluid space following paddle lead spinal cord stimulation at T9: a long-term follow-up via three-dimensional myelographic computed tomography.
        Neuromodulation. 2022; 25: 763-774
        • Kallewaard J.W.
        • Edelbroek C.
        • Terheggen M.
        • Raza A.
        • Geurts J.W.
        A prospective study of dorsal root ganglion stimulation for non-operated discogenic low back pain.
        Neuromodulation. 2020; 23: 196-202
        • Kapural L.
        • Yu C.
        • Doust M.W.
        • et al.
        Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial.
        Anesthesiology. 2015; 123: 851-860
        • Kashcheev A.A.
        • Gushcha A.O.
        • Tjurnikov V.M.
        • et al.
        Spinal cord stimulation for fail back surgery syndrome: literature review and clinical study.
        Coluna Columna. 2018; 17: 212-215
        • Kinfe T.M.
        • Quack F.
        • Wille C.
        • Schu S.
        • Vesper J.
        Paddle versus cylindrical leads for percutaneous implantation in spinal cord stimulation for failed back surgery syndrome: a single-center trial.
        J Neurol Surg A Cent Eur Neurosurg. 2014; 75: 467-473
        • Kumar K.
        • Nath R.
        • Wyant G.M.
        Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience.
        J Neurosurg. 1991; 75: 402-407
        • Kumar K.
        • Taylor R.S.
        • Jacques L.
        • et al.
        Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome.
        Pain. 2007; 132: 179-188
        • Logé D.
        • Vanneste S.
        • Vancamp T.
        • Rijckaert D.
        Long-term outcomes of spinal cord stimulation with percutaneously introduced paddle leads in the treatment of failed back surgery syndrome and lumboischialgia.
        Neuromodulation. 2013; 16 ([discussion: 545]): 537-545
        • McNab D.
        • Khan S.N.
        • Sharples L.D.
        • et al.
        An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial.
        Eur Heart J. 2006; 27: 1048-1053
        • Mearini M.
        • Bergomi R.
        • Panciani P.P.
        • et al.
        Dorsal paddle leads implant for spinal cord stimulation through laminotomy with midline structures preservation.
        Surg Neurol Int. 2012; 3: 164
        • Mekhail N.
        • Levy R.M.
        • Deer T.R.
        • et al.
        Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.
        Lancet Neurol. 2020; 19: 123-134
        • North R.B.
        • Kidd D.H.
        • Olin J.
        • et al.
        Spinal cord stimulation for axial low back pain: a prospective, controlled trial comparing dual with single percutaneous electrodes.
        Spine. 2005; 30: 1412-1418
        • North R.B.
        • Kidd D.H.
        • Petrucci L.
        • Dorsi M.J.
        Spinal cord stimulation electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: part II-clinical outcomes.
        Neurosurgery. 2005; 57 ([discussion: 990–996]): 990-996
        • Oakley J.C.
        • Espinosa F.
        • Bothe H.
        • et al.
        Transverse tripolar spinal cord stimulation: results of an international multicenter study.
        Neuromodulation. 2006; 9: 192-203
        • Oakley J.C.
        • Krames E.S.
        • Prager J.P.
        • et al.
        A new spinal cord stimulation system effectively relieves chronic, intractable pain: a multicenter prospective clinical study.
        Neuromodulation. 2007; 10: 262-278
        • Ohnmeiss D.D.
        • Rashbaum R.F.
        • Bogdanffy G.M.
        Prospective outcome evaluation of spinal cord stimulation in patients with intractable leg pain.
        Spine. 1996; 21 ([discussion: 1351]): 1344-1350
        • Piedade G.S.
        • Vesper J.
        • Chatzikalfas A.
        • Slotty P.J.
        Cervical and high-thoracic dorsal root ganglion stimulation in chronic neuropathic pain.
        Neuromodulation. 2019; 22: 951-955
        • Pluijms W.A.
        • Slangen R.
        • Bakkers M.
        • et al.
        Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study.
        Br J Anaesth. 2012; 109: 623-629
        • Remacle T.Y.
        • Bonhomme V.L.
        • Renwart H.-J.P.
        • Remacle J.M.
        Effect of multicolumn lead spinal cord stimulation on low back pain in failed back surgery patients: a three-year follow-up.
        Neuromodulation. 2017; 20: 668-674
        • Rigoard P.
        • Billot M.
        • Ingrand P.
        • et al.
        How should we use multicolumn spinal cord stimulation to optimize back pain spatial neural targeting? A prospective, multicenter, randomized, double-blind, controlled trial (ESTIMET study).
        Neuromodulation. 2021; 24: 86-101
        • Rosenberg J.
        • Fabi A.
        • Candido K.
        • et al.
        Spinal cord stimulation provides pain relief with improved psychosocial function: results from EMP3OWER.
        Pain Med. 2016; 17: 2311-2325
        • Roth S.G.
        • Lange S.
        • Haller J.
        • et al.
        A prospective study of the intra- and postoperative efficacy of intraoperative neuromonitoring in spinal cord stimulation.
        Stereotact Funct Neurosurg. 2015; 93: 348-354
        • Russo M.
        • Cousins M.J.
        • Brooker C.
        • et al.
        Effective relief of pain and associated symptoms with closed-loop spinal cord stimulation system: preliminary results of the Avalon study.
        Neuromodulation. 2018; 21: 38-47
        • Schultz D.M.
        • Webster L.
        • Kosek P.
        • Dar U.
        • Tan Y.
        • Sun M.
        Sensor-driven position-adaptive spinal cord stimulation for chronic pain.
        Pain Phys. 2012; 15: 1-12
        • Shamji M.F.
        • Paul D.
        • Mednikov A.
        Minimally invasive placement of spinal cord stimulator paddle electrodes is associated with improved perioperative and long-term experience among neuropathic pain patients.
        Spine. 2018; 43: 324-330
        • Tate J.L.
        • Stauss T.
        • Li S.
        • Rotte A.
        • Subbaroyan J.
        A prospective, multi-center, clinical trial of a 10-kHz spinal cord stimulation system in the treatment of chronic pelvic pain.
        Pain Pract. 2021; 21: 45-53
        • Van Buyten J.P.
        • Al-Kaisy A.
        • Smet I.
        • Palmisani S.
        • Smith T.
        High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study.
        Neuromodulation. 2013; 16 ([discussion: 65–56]): 59-65
        • Verrills P.
        • Salmon J.
        • Russo M.
        • Gliner B.
        • Barnard A.
        • Caraway D.
        10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.
        Eur Spine J. 2020; 29: 2786-2794
        • Kim C.H.
        • Green A.W.
        • Rodgers D.E.
        • Issa M.A.
        • Ata M.A.
        Importance of axial migration of spinal cord stimulation trial leads with position.
        Pain Phys. 2013; 16: E763-E768
        • Tjeertes E.K.
        • Hoeks S.E.
        • Beks S.B.
        • Valentijn T.M.
        • Hoofwijk A.G.
        • Stolker R.J.
        Obesity-a risk factor for postoperative complications in general surgery?.
        BMC Anesthesiol. 2015; 15: 112
        • North R.B.
        • Kidd D.H.
        • Olin J.C.
        • Sieracki J.M.
        Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes.
        Neurosurgery. 2002; 51 ([discussion: 389–390]): 381-389
        • D’Souza R.S.
        • D'Souza S.
        • Sharpe E.E.
        YouTube as a source of medical information about epidural analgesia for labor pain.
        Int J Obstet Anesth. 2021; 45: 133-137
        • Langford B.
        • Hooten W.M.
        • D'Souza S.
        • Moeschler S.
        • D'Souza R.S.
        YouTube as a source of medical information about spinal cord stimulation.
        Neuromodulation. 2021; 24: 156-161