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Table 2 Study outcomes (intention to treat)

From: Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

  Group N Baseline
Mean ± SD
3 months
Mean ± SD
Trt effect*
Mean (95% CI)
P-value
Primary outcome
 Average NRS (over 7 days) Active 31 7.1 ± 1.3 6.2 ± 1.9 − 0.3 (− 1.0, 0.3)  
Sham 34 7.3 ± 1.4 6.7 ± 1.7 0 0.30
Secondary outcomes
 EQ VAS Active 31 48 ± 18 61 ± 20 10 (0, 19)  
Sham 34 57 ± 25 56 ± 24 0 0.05
 EQ-5D Index Active 31 0.36 ± 0.25 0.46 ± 0.29 0.04 (− 0.06, 0.14)  
Sham 34 0.35 ± 0.29 0.41 ± 0.31 0 0.40
 BPI I Active 31 6.3 ± 1.9 4.9 ± 2.6 − 0.9 (− 1.7, 0.0)  
Sham 34 6.3 ± 2.0 5.8 ± 2.3 0 0.06
Exploratory outcomes
 BPI worst pain Active 31 8.4 ± 1.0 7.0 ± 1.9 − 0.8 (− 1.6, 0.1)  
  Sham 34 8.0 ± 3.0 7.4 ± 1.9 0 0.07
 HADS anxiety Active 31 11.0 ± 4.7 9.2 ± 5.1 − 0.9 (− 2.3, 0.5)  
  Sham 34 10.6 ± 5.1 9.7 ± 4.5 0 0.22
 HADS depression Active 31 9.4 ± 4.9 8.3 ± 4.9 − 1.1 (− 2.4, 0.3)  
Sham 34 9.0 ± 4.5 9.0 ± 5.0 0 0.13
 PESQ Active 31 23 ± 13 28 ± 15 1 (− 2, 5)  
Sham 34 24 ± 15 27 ± 16 0 0.46
DMA mapped area (cm2) Active 31 211 ± 204 173 ± 215 − 74 (− 126, − 22)  
Sham 34 180 ± 145 215 ± 202 0 0.006
NPSI total Active 31 63 ± 15 52 ± 19 − 5 (− 12, 2)  
Sham 34 59 ± 18 55 ± 16 0 0.13
  1. N: the number of patients with both baseline and end of treatment outcomes; Average NRS: Average pain intensity; EQ VAS: EuroQol visual analogue score; EQ-5D Index: EQ-5D-5L index score (utility); BPI I: Brief pain inventory interference subscale; BPI W: Brief pain inventory worst pain intensity; HADS anxiety: Hospital anxiety and depression scale anxiety subscale; HADS depression: depression subscale; PSEQ: Pain self-efficacy questionnaire; DMA mapped area: Dynamic allodynia mapped area; NPSI total: Neuropathic pain symptom inventory subscale total score
  2. * Trt effect = Treatment effect is difference in outcome between treatment groups, adjusted for outcome at baseline. All analyses using ANCOVA
  3. ** Total costs (mean and 95% confidence intervals generated from 1,000 bootstrap replications) relate to the 3-month periods prior to baseline and follow-up and exclude the cost of device.