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. 2018 Jul 31;6:e5318. doi: 10.7717/peerj.5318

Table 4. Characteristics and results of included group comparisons (N = 26 group comparisons).

Author & year n Dropoutsa [reasons] Type of sham Blinding index (95% CI) Blinding scenario (AG/SG) Reported blinding results Reported blinding conclusion Between-group SMD (pain) and reported p-values [−ve values in favour of AG]
Cotchett, Munteanu & Landorf (2014) 84 5
AG: 3 [1 missed Ax; 2 ceased Ix]
SG: 2 [1 missed Ax; 1 ceased Ix]
NP: Custom (blunt needle) Insufficient data NSD between groups (CEQ) (p > 0.05 for all questions) Success ST: −0.05 (p = 0.026)
LT: −0.42 (p = 0.007)
Huguenin et al. (2005) 52 7 [difficulty attending] NP: Custom (blunt needle) Insufficient data AG only:
  • Immed: Correct (p = 0.001)
  • ST: NSD between correct and incorrect guesses (p = 0.062)
Success Immed/B: d(NSD)
ST: d(NSD)
Inoue et al. (2006) 31 0 NP: Custom (guide tube only) AG: 0.20 (−0.30–0.70)
SG: 0.25 (−0.22–0.72)
Correct/Correct
NSD between groups (p NR)
AG: 9/15 correct
SG: 10/16 correct
Success Immed/B: 0.76 (p = 0.020)
bItoh & Katsumi (2005) (NP) 19 3
AG: 1
SG: 2
[All groups: 5 DNR; 2 AE]
NP: Custom (guide tube only) cAG: 0.60 (0.10–1.10)
cSG: −0.11 (−0.76–0.54)
Correct/Random
NSD between groups (p = 0.64)
AG: 8/10 correct
SG: 4/9 correct
Success ST: −0.82 (p <0.05)
B: −2.35 (p <0.01)
LT: −0.98 (NSD)
bItoh & Katsumi (2005) (P) 19 3
AG: 1
SG: 2
[All groups: 5 DNR; 2 AE]
P: TrP SDN cAG: 0.60 (0.10–1.10)
cSG: −0.20 (−0.81–0.41)
Correct/Incorrect
NSD between groups (p = 0.64)
AG: 8/10 correct
SG: 4/10 correct
Success ST: −0.77 (NSD)
B: −0.67 (p <0.05)
LT: −0.13 (NSD)
Sterling et al. (2015) 80 7
AG: 3 [LTFU]
SG: 4 [LTFU]
NP: Commercial (Park sham) Insufficient data Descriptive only
SG: 1/36 correct
[All remaining participants believed AG or DK]
Success LT: −0.04 (NSD)
B: −0.09 (NSD)
Dıraçoğlu et al. (2012) 50 2
AG: 1 [difficulty attending]
SG: 1 [DNR]
P: Non-TrP SDN Did not assess blinding ST: 0.06 (p = 0.478)
Espejo Antúnez et al. (2014) 45 0 NP: Custom (retracting needle) Did not assess blinding Immed: −1.15 (p <0.01)
García-Gallego et al. (2011) 33 0 P: Non-TrP DN Did not assess blinding Immed: 0.09 (NSD)
ST: 0.17 (NSD)
Itoh, Katsumi & Kitakoji (2004) 18 4
AG: 1 [AE]
SG: 3 [DNR]
P: TrP SDN Did not assess blinding ST: −0.72 (NSD)
LT: −0.21 (NSD)
Itoh et al. (2006a) 19 7
AG: 3 [2 DNR; 1 AE]
SG: 4 [DNR]
NP: Custom (blunt needle) AG: 0.50 (0.00–1.00)
SG: −0.11 (−0.68–0.46)
Correct/Random
NSD between groups (p = 0.38)
AG: 7/10 correct; 1/10 DK
SG: 3/9 correct; 2/9 DK
Success ST: −1.38 (NSD)
B: −3.43 (p <0.001)
LT: −1.19 (NSD)
Itoh et al. (2006b) 18 5
AG: 2
SG: 3
[All groups: 4 DNR; 2 drugs]
NP: Custom (blunt needle) AG: NR
SG: −0.56 (−1.00–−0.11)
NR/Incorrect
Descriptive only (SG only)
SG: 1/9 correct; 2/9 DK
NR ST/B: −1.11 (p <0.05)
LT: −0.35 (NSD)
bItoh et al. (2007) (NP) 15 5
AG: 2 [1 DNR; 1 AE]
SG: 3 [2 DNR; 1 AE)
NP: Custom (blunt needle) AG: 0.38 (−0.11–0.86)
SG: −0.29 (−0.94–0.37)
Correct/Incorrect
NSD between groups (p = 0.89)
AG: 4/8 correct; 3/8 DK
SG: 2/7 correct; 1/7 DK
Success ST: −0.71 (NSD)
B: −1.87 (NSD)
LT: −2.52 (NSD)
bItoh et al. (2007) (P) 16 4
AG: 2 [1 DNR; 1 AE]
SG: 2 [1 DNR; 1 AE]
P: Non-TrP DN AG: 0.38 (−0.11–0.86)
SG: −0.38 (−0.86–0.11)
Correct/Incorrect
NSD between groups (p = 0.89)
AG: 4/8 correct; 3/8 DK
SG: 1/8 correct; 3/8 DK
Success ST: −1.32 (NSD)
B: −2.25 (NSD)
LT: −3.25 (NSD)
Itoh et al. (2008) 15 5
AG: 2 [1 DNR; 1 AE]
SG: 3 [DNR]
NP: Custom (blunt needle) AG: 0.75 (0.29–1.21)
SG: −0.43 (−1.10–0.24)
Correct/Incorrect
NSD between groups (p = 0.74)
AG: 7/8 correct
SG: 2/7 correct
Success ST: −1.95
B: −2.67
LT: −0.81
(AUC p = 0.025)
Itoh et al. (2012) 15 1
AG: 1 [AE]
NP: Custom (blunt needle) AG: 1.00 (1.00–1.00)
SG: −1.00 (−1.00–−1.00)
Correct/Incorrect
Descriptive only
[All participants believed they were in AG]
Success ST: −0.46
B: −1.83
LT: −1.65
(AUC p = 0.003)
Itoh et al. (2014) 15 1
SG: 1 [DNR]
NP: Custom (blunt needle) AG: 0.56 (0.01–1.10)
SG: −0.50 (−1.10–0.10)
Correct/Incorrect
NSD between groups (p = 0.89)
AG: 7/9 correct
SG: 2/8 correct
Success ST: −0.96
B: −1.29
LT: −1.44
(AUC p = 0.024)
Katsumi et al. (2004) 9 0 NP: Custom (guide tube only) AG: 1.00 (1.00–1.00)
SG: −0.60 (−1.30–0.10)
Correct/Incorrect
Descriptive only
AG: 4/4 correct
SG: 1/5 correct
NR ST: −0.64 (NR)
B: −4.36 (NR)
LT: −0.73 (NR)
Mayoral et al. (2013) 31 9
AG: 4 [LTFU]
SG: 5 [LTFU]
No needle: GA/SA Did not assess blinding ST: −0.34 (p = 0.294)
LT: −0.23 (p = 0.516)
McMillan, Nolan & Kelly (1997) 20 NR P: Non-TrP SDN Did not assess blinding Immed: 0.35 (NSD)
ST: 0.26 (NSD)
Myburgh et al. (2012) 77 4
AG: 4 [2 non-compliant; 1 AE;
1 NR]
P: TrP SDN Did not assess blinding ST: −0.37 (NSD)
Nabeta & Kawakita (2002) 34 7
AG: 2 [difficulty attending]
SG: 5 [difficulty attending]
NP: Custom (blunt needle) AG: 0.41 (0.01–0.81)
SG: −0.18 (−0.62–0.26)
Correct/Random
NSD between groups (p = 0.74)
AG: 11/17 correct; 2/17 DK
SG: 6/17 correct; 2/17 DK
Success Immed: −0.12 (NSD)
ST: −0.31 (NSD)
B: −0.25 (NSD)
Pecos-Martín et al. (2015) 72 0 P: Non-TrP DN Did not assess blinding ST: −1.59 (p <0.001)
LT: −1.93 (p <0.001)
Tekin et al. (2013) 39 7
AG: 1 [ceased Ix]
SG: 6 [ceased Ix]
NP: Custom (blunt needle) Did not assess blinding Immed: −0.88 (p = 0.034)
ST: −1.62 (p = 0.000)
Tough et al. (2009)/Tough et al. (2010) 41 7
AG: 3 [LTFU]
SG: 4 [LTFU]
NP: Custom (blunt needle) AG: 0.53 (0.30–0.75)
SG: −0.67 (−0.93–−0.40)
Correct/Incorrect
NSD between groups (p>0.2)
AG: 10/19 correct; 9/19 DK
SG: 1/18 correct; 4/18 DK
Success ST/B: 0.11 (NR)
LT: −0.61 (p = 0.67)
Tsai et al. (2010) 35 0 P: TrP SDN Did not assess blinding Immed: −0.91 (p <0.05)

Notes.

a

Dropouts for pain outcome.

b

Itoh & Katsumi (2005) and Itoh et al. (2007) each had two eligible sham groups; in both of these trials one group had a non-penetrating (NP) sham and the other had a penetrating (P) sham (labelled accordingly in the first column of the table).

c

Itoh & Katsumi (2005) only reported the number of participants from each group who guessed they were in the active group, therefore, to calculate the BI it was conservatively assumed that the remaining participants guessed they were in the sham group (i.e., no DK responses).

d

Data not reported as mean/SD (could not calculate SMD).

n
number of participants (analysed for pain outcome)]
95% CI
95% Confidence Interval
AG
Active Group
SG
Sham Group
SMD
Standardised Mean Difference
−ve
Negative
Ax
Assessment
Ix
Intervention
NP
Non Penetrating
NSD
No Significant Difference
CEQ
Credibility/Expectancy Questionnaire
ST
Short-Term (24 hours to four weeks, closest assessment to one week)
LT
Long-Term (one to six months, closest assessment to three months)
Immed
Immediately post-intervention (<24 hours after first/only intervention)
B
time-point at which Blinding was assessed
NR
Not Reported
DNR
Did Not Respond (to intervention)
AE
Adverse Effects
P
Penetrating
TrP SDN
Superficial Dry Needling above Trigger Point
LTFU
Loss To Follow Up
DK
Don’t Know
Non-TrP SDN
Superficial Dry Needling away from Trigger Point
Non-TrP DN
Dry Needling away from Trigger Point
AUC
Area Under Curve
GA
General Anaesthesia
SA
Spinal Anaesthesia

Shading represents adequately blinded trials (based on critical appraisal criteria for review question 2).