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Table 3 Minimally clinical important difference change (MCID) for outcomes

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

 

Active

Sham

Fisher’s exact

P-value

N

n (%)

N

n (%)

Primary outcomes

 ≥ 2 points OR ≥ 30%*

31

9 (29%)

34

6 (18%)

0.131

Secondary outcomes

 EQ-VAS ≥ 11

31

12 (39%)

34

7 (21%)

0.061

 EQ 5D-Index ≥ 0.145

31

14 (45%)

34

10 (29%)

0.088

 BPI I ≥ 2

31

9 (29%)

34

6 (18%)

0.131

Exploratory outcomes

 BPI W ≥ 3*

31

8 (26%)

34

5 (15%)

0.134

 HADS Anxiety ≥ 4**

31

8 (26%)

34

5 (15%)

0.134

 HADS Depression ≥ 4 **

31

6 (19%)

34

2 (6%)

0.082

 PSEQ ≥ 7 **

31

9 (29%)

34

6 (18%)

0.131

 DMA mapped area ≥ ***

31

16 (52%)

34

10 (29%)

0.039

Total mean

31

33% (± 11)

34

19% (± 7.1)

0.005Â¥

  1. 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 scale anxiety subscale; HADS depression: Hospital anxiety scale depression subscale; PSEQ: Pain self-efficacy questionnaire; DMA mapped area: Dynamic allodynia mapped area;  ± standard deviation, ¥ Mann Whitney
  2. * % change based on pain score at baseline
  3. ** Also met additional criteria of movement to different severity category
  4. ***  > 20% change based on area at baseline