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Prospective randomized feasibility study comparing manual vs. automatic position-adaptive spinal cord stimulation with surgical leads

  • Original Article - Functional Neurosurgery - Pain
  • Published:
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Abstract

Background

The majority of patients experience uncomfortable stimulation associated with posture changes, especially when lying down. The spinal cord moves within the intrathecal space in response to positional changes affecting the size of the stimulated area accordingly and causing overstimulation or understimulation. To accommodate for positional changes, patients have to manually adjust the stimulation parameters; therefore, an automatic position-adaptive SCS was designed to address these issues. The primary objective of this study was to establish the extent of position-related variations in SCS stimulation parameters experienced by chronic pain patients implanted with surgical, laminectomy-type leads under both automatic and manual SCS conditions.

Methods

A total of 18 patients completed a single-center, prospective, non-blinded, randomized (1:1), feasibility clinical study with a two-arm crossover design. All patients undergoing SCS treatment for chronic refractory back and or leg pain associated with failed back surgery, post-laminectomy, or radicular pain syndromes that were refractory to conservative and surgical interventions were eligible for enrollment. After the manual stimulation mode, the patients were randomized to one of two study arms: manual or automatic position-adaptive stimulation and then crossed over to a different arm. All patients were followed for a total of 5 months (± 2 weeks).

Results

Analysis indicated statistically significant differences between therapeutic and threshold stimulation intensity for the supine position compared with all other body positions when using either automatic position-adaptive stimulation or manual stimulation, except for threshold amplitudes in the prone position for automatic stimulation.

Conclusion

Similar variations were reported for manual and automatic stimulation intensity in response to positional changes.

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Abbreviations

ANOVA:

Analysis of variance

BMI:

Body mass index

CI:

Confidence interval

DOS:

Duration of symptoms.

EBL:

Estimated blood loss.

F:

Female

M:

Male

N:

Number

ODI:

Oswestry Disability Index

OR:

Operating room

PSQI:

Pittsburgh Sleep Quality Index

RM:

Repeat measure

SCS:

Spinal cord stimulator

VAS:

Visual analog scale

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Authorship statement

Protocol development, data collection, data analysis, and manuscript preparation were performed by the authors.

Funding

Medtronic, Inc. (Minneapolis, MN) provided a research grant to support this study with direct payments to Justin Parker Neurological Institute (Boulder, CO).

Author information

Authors and Affiliations

  1. Boulder Neurosurgical Associates, 4743 Arapahoe Avenue, Suite 202, Boulder, CO, 80303, USA

    Kara Beasley, Christie Zakar & Sigita Burneikiene

  2. University of Colorado, Boulder, CO, USA

    Steven Hobbs

  3. Justin Parker Neurological Institute, Boulder, CO, USA

    Vinod Kantha & Sigita Burneikiene

Authors
  1. Kara Beasley
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  2. Christie Zakar
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  3. Steven Hobbs
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  4. Vinod Kantha
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  5. Sigita Burneikiene
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Corresponding author

Correspondence to Sigita Burneikiene.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

The study was approved by IRB and registered: https://clinicaltrials.gov/ct2/show/NCT01874899?term=justin+parker+neurological&rank=1

Informed consent

Informed consent was obtained from all individual participants included in the study.

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This article is part of the Topical Collection on Functional Neurosurgery—Pain

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Beasley, K., Zakar, C., Hobbs, S. et al. Prospective randomized feasibility study comparing manual vs. automatic position-adaptive spinal cord stimulation with surgical leads. Acta Neurochir 161, 1571–1578 (2019). https://doi.org/10.1007/s00701-019-03943-z

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  • DOI: https://doi.org/10.1007/s00701-019-03943-z

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