PMID- 22751030
OWN - NLM
STAT- MEDLINE
DCOM- 20130605
LR  - 20121205
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Linking)
VI  - 29
IP  - 1
DP  - 2013 Jan
TI  - Treatment of chronic, intractable pain with a conventional implantable pulse 
      generator: a meta-analysis of 4 clinical studies.
PG  - 78-85
LID - 10.1097/AJP.0b013e318247309a [doi]
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.
FAU - Slavin, Konstantin V
AU  - Slavin KV
AD  - Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL 60612, 
      USA. kslavin@uic.edu
FAU - Vaisman, Julien
AU  - Vaisman J
FAU - Pollack, Kenneth L
AU  - Pollack KL
FAU - Simopoulos, Thomas T
AU  - Simopoulos TT
FAU - Kowlowitz, Edward
AU  - Kowlowitz E
FAU - Weinand, Martin E
AU  - Weinand ME
FAU - Norregaard, Thorkild V
AU  - Norregaard TV
CN  - Genesis Study Investigators
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Multicenter Study
PL  - United States
TA  - Clin J Pain
JT  - The Clinical journal of pain
JID - 8507389
SB  - IM
MH  - Electric Stimulation Therapy/*instrumentation/*statistics & numerical data
MH  - Equipment Design
MH  - Equipment Failure Analysis
MH  - *Evidence-Based Medicine
MH  - Female
MH  - Humans
MH  - Male
MH  - Pain, Intractable/*epidemiology/*prevention & control
MH  - Patient Satisfaction/statistics & numerical data
MH  - Prevalence
MH  - Prostheses and Implants/*statistics & numerical data
MH  - Risk Factors
MH  - Treatment Outcome
EDAT- 2012/07/04 06:00
MHDA- 2013/06/06 06:00
CRDT- 2012/07/04 06:00
PHST- 2012/07/04 06:00 [entrez]
PHST- 2012/07/04 06:00 [pubmed]
PHST- 2013/06/06 06:00 [medline]
AID - 10.1097/AJP.0b013e318247309a [doi]
PST - ppublish
SO  - Clin J Pain. 2013 Jan;29(1):78-85. doi: 10.1097/AJP.0b013e318247309a.