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. Author manuscript; available in PMC: 2015 Jan 17.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2
Methods RCT.
Participants 40 women attending a Boston (USA) hospital.
Inclusion criteria: women in active, spontaneous labour with singleton, vertex, term pregnancy, requesting epidural. Cervical dilatation less than 5 cm on recruitment
Interventions All women had a Bupivacaine epidural.
Intervention: TENS to lower back.
Comparison Group: placebo/inactive TENS.
Outcomes VAS pain scores, use of oxytocin, fetal heart rate, Apgar scores and maternal side effects
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided.
Allocation concealment (selection bias) Low risk “Sequentially numbered, opaque, shuffled envelopes”.
Blinding (performance bias and detection bias)
Participants
Unclear risk Described as double-blind trial. TENS machines were in pouches so women could not see if they were on or off
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk Unclear.
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk Unclear.
Incomplete outcome data (attrition bias)
All outcomes
Low risk All women included in the analysis.
Other bias Unclear risk Some baseline differences, 7/20 women in the intervention group and 3/20 in the control group had opiate analgesia before entry to the study