Treatment of chronic, intractable pain with a conventional implantable pulse generator

A meta-analysis of 4 clinical studies

Konstantin V. Slavin, Julien Vaisman, Kenneth L. Pollack, Thomas T. Simopoulos, Edward Kowlowitz, Martin E Weinand, Thorkild V. Norregaard

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: To provide further short-term (6 mo) and long-term (1 y) evidence for the use of spinal cord stimulation (SCS) with a conventional implantable pulse generator in the management of chronic, intractable pain. MATERIALS AND Methods: We conducted a meta-analysis of 4 prospective, multicenter studies that collected outcome data from patients implanted with SCS to treat chronic pain of the trunk and/or limbs (Genesis IPG system). Two of these were conducted as long-term studies lasting 1 year, and 2 as shorter term studies lasting 6 months. A total of 300 patients from 28 investigational sites were prospectively evaluated for efficacy at 3 months after implant and safety at 6 months after implant. None of the sites participated in more than one study. Outcome measures included patient-reported percent of pain relief, patient satisfaction, quality of life improvement, pain evaluation (0 to 10 rating), pain relief rating, Short-Form McGill Pain Questionnaire, visual analog scale, the Short Form-36, and the total number of adverse events (AEs). Results: At 3 months after implantation of the permanent system, 75.4% of the patients (190/252) reported a 50% or greater pain relief as determined by the patient-reported degree of pain relief. Similarly, assessment of patient satisfaction with SCS therapy showed that 86.1% of patients (217/252) in all 4 studies were satisfied or very satisfied with the therapy at 3 months. In the 2 long-term studies, 80.9% of patients (140/173) were satisfied or very satisfied with the therapy at the 1-year evaluation point. Quality-of-life (QoL) data indicated that at 3 months after implant, 77.8% of patients (196/252) reported QoL as improved or greatly improved. Similarly, QoL was improved or greatly improved for 74.0% patients in the long-term study at 1 year (128/173). In the safety analysis, AEs were reviewed for all 4 studies. A total of 190 AEs were reported in 117 of 300 patients during all studies. Conclusions: This analysis provides further evidence of the safety and effectiveness of SCS in treating chronic intractable pain of the trunk and/or limbs. Specifically, it underscores a high level of effectiveness and acceptable safety concerns in the use of nonrechargeable SCS devices.

Original languageEnglish (US)
Pages (from-to)78-85
Number of pages8
JournalClinical Journal of Pain
Volume29
Issue number1
DOIs
StatePublished - Jan 2013

Fingerprint

Intractable Pain
Chronic Pain
Meta-Analysis
Spinal Cord Stimulation
Pain
Quality of Life
Safety
Therapeutics
Patient Satisfaction
Extremities
Clinical Studies
Pain Measurement
Quality Improvement
Visual Analog Scale
Multicenter Studies
Prospective Studies
Equipment and Supplies

Keywords

  • chronic pain
  • complex regional pain syndrome
  • failed back surgery syndrome
  • intractable low back and leg pain
  • neuromodulation
  • spinal cord stimulation

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Clinical Neurology

Cite this

Treatment of chronic, intractable pain with a conventional implantable pulse generator : A meta-analysis of 4 clinical studies. / Slavin, Konstantin V.; Vaisman, Julien; Pollack, Kenneth L.; Simopoulos, Thomas T.; Kowlowitz, Edward; Weinand, Martin E; Norregaard, Thorkild V.

In: Clinical Journal of Pain, Vol. 29, No. 1, 01.2013, p. 78-85.

Research output: Contribution to journalArticle

Slavin, Konstantin V. ; Vaisman, Julien ; Pollack, Kenneth L. ; Simopoulos, Thomas T. ; Kowlowitz, Edward ; Weinand, Martin E ; Norregaard, Thorkild V. / Treatment of chronic, intractable pain with a conventional implantable pulse generator : A meta-analysis of 4 clinical studies. In: Clinical Journal of Pain. 2013 ; Vol. 29, No. 1. pp. 78-85.
@article{e0f92df3b23446008742e87b34b1c80a,
title = "Treatment of chronic, intractable pain with a conventional implantable pulse generator: A meta-analysis of 4 clinical studies",
abstract = "Objective: To provide further short-term (6 mo) and long-term (1 y) evidence for the use of spinal cord stimulation (SCS) with a conventional implantable pulse generator in the management of chronic, intractable pain. MATERIALS AND Methods: We conducted a meta-analysis of 4 prospective, multicenter studies that collected outcome data from patients implanted with SCS to treat chronic pain of the trunk and/or limbs (Genesis IPG system). Two of these were conducted as long-term studies lasting 1 year, and 2 as shorter term studies lasting 6 months. A total of 300 patients from 28 investigational sites were prospectively evaluated for efficacy at 3 months after implant and safety at 6 months after implant. None of the sites participated in more than one study. Outcome measures included patient-reported percent of pain relief, patient satisfaction, quality of life improvement, pain evaluation (0 to 10 rating), pain relief rating, Short-Form McGill Pain Questionnaire, visual analog scale, the Short Form-36, and the total number of adverse events (AEs). Results: At 3 months after implantation of the permanent system, 75.4{\%} of the patients (190/252) reported a 50{\%} or greater pain relief as determined by the patient-reported degree of pain relief. Similarly, assessment of patient satisfaction with SCS therapy showed that 86.1{\%} of patients (217/252) in all 4 studies were satisfied or very satisfied with the therapy at 3 months. In the 2 long-term studies, 80.9{\%} of patients (140/173) were satisfied or very satisfied with the therapy at the 1-year evaluation point. Quality-of-life (QoL) data indicated that at 3 months after implant, 77.8{\%} of patients (196/252) reported QoL as improved or greatly improved. Similarly, QoL was improved or greatly improved for 74.0{\%} patients in the long-term study at 1 year (128/173). In the safety analysis, AEs were reviewed for all 4 studies. A total of 190 AEs were reported in 117 of 300 patients during all studies. Conclusions: This analysis provides further evidence of the safety and effectiveness of SCS in treating chronic intractable pain of the trunk and/or limbs. Specifically, it underscores a high level of effectiveness and acceptable safety concerns in the use of nonrechargeable SCS devices.",
keywords = "chronic pain, complex regional pain syndrome, failed back surgery syndrome, intractable low back and leg pain, neuromodulation, spinal cord stimulation",
author = "Slavin, {Konstantin V.} and Julien Vaisman and Pollack, {Kenneth L.} and Simopoulos, {Thomas T.} and Edward Kowlowitz and Weinand, {Martin E} and Norregaard, {Thorkild V.}",
year = "2013",
month = "1",
doi = "10.1097/AJP.0b013e318247309a",
language = "English (US)",
volume = "29",
pages = "78--85",
journal = "Clinical Journal of Pain",
issn = "0749-8047",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - Treatment of chronic, intractable pain with a conventional implantable pulse generator

T2 - A meta-analysis of 4 clinical studies

AU - Slavin, Konstantin V.

AU - Vaisman, Julien

AU - Pollack, Kenneth L.

AU - Simopoulos, Thomas T.

AU - Kowlowitz, Edward

AU - Weinand, Martin E

AU - Norregaard, Thorkild V.

PY - 2013/1

Y1 - 2013/1

N2 - Objective: To provide further short-term (6 mo) and long-term (1 y) evidence for the use of spinal cord stimulation (SCS) with a conventional implantable pulse generator in the management of chronic, intractable pain. MATERIALS AND Methods: We conducted a meta-analysis of 4 prospective, multicenter studies that collected outcome data from patients implanted with SCS to treat chronic pain of the trunk and/or limbs (Genesis IPG system). Two of these were conducted as long-term studies lasting 1 year, and 2 as shorter term studies lasting 6 months. A total of 300 patients from 28 investigational sites were prospectively evaluated for efficacy at 3 months after implant and safety at 6 months after implant. None of the sites participated in more than one study. Outcome measures included patient-reported percent of pain relief, patient satisfaction, quality of life improvement, pain evaluation (0 to 10 rating), pain relief rating, Short-Form McGill Pain Questionnaire, visual analog scale, the Short Form-36, and the total number of adverse events (AEs). Results: At 3 months after implantation of the permanent system, 75.4% of the patients (190/252) reported a 50% or greater pain relief as determined by the patient-reported degree of pain relief. Similarly, assessment of patient satisfaction with SCS therapy showed that 86.1% of patients (217/252) in all 4 studies were satisfied or very satisfied with the therapy at 3 months. In the 2 long-term studies, 80.9% of patients (140/173) were satisfied or very satisfied with the therapy at the 1-year evaluation point. Quality-of-life (QoL) data indicated that at 3 months after implant, 77.8% of patients (196/252) reported QoL as improved or greatly improved. Similarly, QoL was improved or greatly improved for 74.0% patients in the long-term study at 1 year (128/173). In the safety analysis, AEs were reviewed for all 4 studies. A total of 190 AEs were reported in 117 of 300 patients during all studies. Conclusions: This analysis provides further evidence of the safety and effectiveness of SCS in treating chronic intractable pain of the trunk and/or limbs. Specifically, it underscores a high level of effectiveness and acceptable safety concerns in the use of nonrechargeable SCS devices.

AB - Objective: To provide further short-term (6 mo) and long-term (1 y) evidence for the use of spinal cord stimulation (SCS) with a conventional implantable pulse generator in the management of chronic, intractable pain. MATERIALS AND Methods: We conducted a meta-analysis of 4 prospective, multicenter studies that collected outcome data from patients implanted with SCS to treat chronic pain of the trunk and/or limbs (Genesis IPG system). Two of these were conducted as long-term studies lasting 1 year, and 2 as shorter term studies lasting 6 months. A total of 300 patients from 28 investigational sites were prospectively evaluated for efficacy at 3 months after implant and safety at 6 months after implant. None of the sites participated in more than one study. Outcome measures included patient-reported percent of pain relief, patient satisfaction, quality of life improvement, pain evaluation (0 to 10 rating), pain relief rating, Short-Form McGill Pain Questionnaire, visual analog scale, the Short Form-36, and the total number of adverse events (AEs). Results: At 3 months after implantation of the permanent system, 75.4% of the patients (190/252) reported a 50% or greater pain relief as determined by the patient-reported degree of pain relief. Similarly, assessment of patient satisfaction with SCS therapy showed that 86.1% of patients (217/252) in all 4 studies were satisfied or very satisfied with the therapy at 3 months. In the 2 long-term studies, 80.9% of patients (140/173) were satisfied or very satisfied with the therapy at the 1-year evaluation point. Quality-of-life (QoL) data indicated that at 3 months after implant, 77.8% of patients (196/252) reported QoL as improved or greatly improved. Similarly, QoL was improved or greatly improved for 74.0% patients in the long-term study at 1 year (128/173). In the safety analysis, AEs were reviewed for all 4 studies. A total of 190 AEs were reported in 117 of 300 patients during all studies. Conclusions: This analysis provides further evidence of the safety and effectiveness of SCS in treating chronic intractable pain of the trunk and/or limbs. Specifically, it underscores a high level of effectiveness and acceptable safety concerns in the use of nonrechargeable SCS devices.

KW - chronic pain

KW - complex regional pain syndrome

KW - failed back surgery syndrome

KW - intractable low back and leg pain

KW - neuromodulation

KW - spinal cord stimulation

UR - http://www.scopus.com/inward/record.url?scp=84871610934&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84871610934&partnerID=8YFLogxK

U2 - 10.1097/AJP.0b013e318247309a

DO - 10.1097/AJP.0b013e318247309a

M3 - Article

VL - 29

SP - 78

EP - 85

JO - Clinical Journal of Pain

JF - Clinical Journal of Pain

SN - 0749-8047

IS - 1

ER -