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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 Randomised trial (methods unclear).
Participants 25 women (30 women were recruited to this 5-arm trial, we have not included data for the arm where women (n = 5) were allocated to receive pethidine)
Inclusion criteria: “co-operative patients” with no drug dependency. Various ages and social groups
Exclusion criteria: unclear.
Interventions 5 study groups:
1) TENS group - TENS to lower back (10 women).
2) 50 mg pethidine (5 women).
3) Placebo TENS (no current) (5 women).
4) “Wrong” TENS (electrodes applied to wrong positions) (5 women)
5) No analgesia or intervention (5 women).
Outcomes Pain measured on a VAS over 70-minute period. Progress in labour
Notes Paper in German. Translation notes used for data extraction.
In the analysis in this review study groups 3 to 5 have been combined to form the control group
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described - “randomly divided”.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding (performance bias and detection bias)
Participants
Unclear risk The study included two placebo TENS devices (TENS with no current or TENS with the electrodes in the wrong position). It is not clear if the placebo devices were convincing to women or others
Blinding (performance bias and detection bias)
Clinical staff
Unclear risk It is not clear if the placebo devices were convincing to women or others
Blinding (performance bias and detection bias)
Outcome assessor
Unclear risk It is not clear if the placebo devices were convincing to women or others
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk One woman was lost to follow up.
Other bias Unclear risk Small study and results were difficult to interpret.