PMID- 36574755
OWN - NLM
STAT- MEDLINE
DCOM- 20230224
LR  - 20230307
IS  - 1423-0372 (Electronic)
IS  - 1011-6125 (Linking)
VI  - 101
IP  - 1
DP  - 2023
TI  - Establishing Minimal Clinically Important Difference in Sleep Outcomes after 
      Spinal Cord Stimulation in Patients with Chronic Pain Disorders.
PG  - 41-46
LID - 10.1159/000527257 [doi]
AB  - INTRODUCTION: As one of the most common medical conditions for which patients 
      seek medical care, chronic pain can be debilitating. The relationship between 
      chronic pain and sleep is thought to be bidirectional, suggesting that treatment 
      of one can be beneficial to the other. There is mounting evidence that spinal 
      cord stimulation (SCS) improves aspects of sleep. How meaningful that is to 
      patients' lives has not been ascertained. OBJECTIVE: The aim of the current study 
      was to further elucidate the effect of SCS on sleep by examining the relationship 
      between pain outcome measures with the insomnia severity index (ISI) and to 
      establish the minimally clinical important difference (MCID), which is defined as 
      the smallest noticeable change that an individual perceives as clinically 
      significant. MATERIALS AND METHODS: We prospectively collected ISI, Epworth 
      sleepiness scale (ESS), Numerical Rating Scale, McGill Pain Questionnaire-Short 
      Form, Oswestry Disability Index, Beck Depression Inventory, and Pain 
      Catastrophizing Scale data both pre- and postoperatively for chronic pain 
      patients who underwent SCS placement and had long-term outcomes. The ISI is a 
      well-studied questionnaire used to assess an individual's level of insomnia. 
      RESULTS: We correlated the ESS and ISI with pain outcome measures in sixty-four 
      patients at a mean follow-up of 9.8 +/- 2.9 months. The ISI showed correlations 
      with disability as measured through the Oswestry Disability Index (p = 0.014) and 
      depression as measured through the Beck Depression Inventory (p = 0.024). MCID 
      values for the ISI were calculated using both anchor- and distribution-based 
      methods. The minimal detectable change method resulted in an MCID of 2.4 points, 
      standard error of measurement resulted in an MCID of 2.6 points, and the change 
      difference resulted in an MCID of 2.45. The receiver operating characteristic 
      method yielded an MCID of 0.5-point change with an area under the curve of 0.61. 
      CONCLUSION: This study successfully established MCID ranges for the ISI outcome 
      measure to help gauge improvement in insomnia after SCS. The ISI has ample 
      evidence of its validity in assessment of insomnia, and MCID values of 2.4-2.6 
      correlate with improvement in disability and depression in our patients.
CI  - (c) 2022 S. Karger AG, Basel.
FAU - Johansen, Phillip M
AU  - Johansen PM
AD  - Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, 
      Florida, USA.
FAU - Trujillo, Frank A
AU  - Trujillo FA
AD  - Department of Neurosurgery, Albany Medical Center, Albany, New York, USA.
FAU - Hagerty, Vivian
AU  - Hagerty V
AD  - Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, 
      Florida, USA.
FAU - Harland, Tessa
AU  - Harland T
AD  - Department of Neurosurgery, Albany Medical Center, Albany, New York, USA.
FAU - Davis, Gregory
AU  - Davis G
AD  - Department of Neurosurgery, Albany Medical Center, Albany, New York, USA.
FAU - Pilitsis, Julie G
AU  - Pilitsis JG
AD  - Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, 
      Florida, USA.
LA  - eng
GR  - R01 CA166379/CA/NCI NIH HHS/United States
GR  - U44 NS115111/NS/NINDS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20221227
PL  - Switzerland
TA  - Stereotact Funct Neurosurg
JT  - Stereotactic and functional neurosurgery
JID - 8902881
SB  - IM
MH  - Humans
MH  - *Chronic Pain/therapy
MH  - Treatment Outcome
MH  - Minimal Clinically Important Difference
MH  - *Spinal Cord Stimulation/methods
MH  - *Sleep Initiation and Maintenance Disorders
MH  - Sleep
OTO - NOTNLM
OT  - Chronic pain
OT  - Insomnia
OT  - Sleep
OT  - Spinal cord stimulation
EDAT- 2022/12/28 06:00
MHDA- 2023/02/25 06:00
CRDT- 2022/12/27 18:22
PHST- 2022/07/04 00:00 [received]
PHST- 2022/08/16 00:00 [accepted]
PHST- 2022/12/28 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
PHST- 2022/12/27 18:22 [entrez]
AID - 000527257 [pii]
AID - 10.1159/000527257 [doi]
PST - ppublish
SO  - Stereotact Funct Neurosurg. 2023;101(1):41-46. doi: 10.1159/000527257. Epub 2022 
      Dec 27.