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

Table 2 Study outcomes (intention to treat)

	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)
Average NRS (over 7 days)	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)
EQ VAS	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)
EQ-5D Index	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)
BPI I	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)
HADS depression	Sham	34	9.0 ± 4.5	9.0 ± 5.0	0	0.13
PESQ	Active	31	23 ± 13	28 ± 15	1 (− 2, 5)
PESQ	Sham	34	24 ± 15	27 ± 16	0	0.46
DMA mapped area (cm²)	Active	31	211 ± 204	173 ± 215	− 74 (− 126, − 22)
DMA mapped area (cm²)	Sham	34	180 ± 145	215 ± 202	0	0.006
NPSI total	Active	31	63 ± 15	52 ± 19	− 5 (− 12, 2)
NPSI total	Sham	34	59 ± 18	55 ± 16	0	0.13

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
* Trt effect = Treatment effect is difference in outcome between treatment groups, adjusted for outcome at baseline. All analyses using ANCOVA
** 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.

ISSN: 1479-5876