Methods | RCT. | |
Participants | Study in Quebec, Canada at a rural hospital. Women at low risk admitted for delivery 35 women included in the analyses. Inclusion criteria: term pregnancy (more than 36 weeks’ gestation), women in active first stage labour who complained of low back pain with no obstetric or medical complications |
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Interventions | Intervention group: TENS to lower back operated by women. Comparison group 1: intracutaneous sterile water to lumbar sacral region (4 injections) Comparison group 2: routine care with massage, whirlpool baths and ambulation encouraged |
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Outcomes | Low back pain, use of other analgesia, satisfaction with labour and delivery measured in postnatal period. Pain measured on a 10 cm VAS in millimetres | |
Notes | The SDs reported for the pain scores were very much lower than might be expected with a VAS and appeared incorrect for some results; where SDs appeared incorrect we have not included data in data and analyses tables | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers in balanced blocks. |
Allocation concealment (selection bias) | Low risk | Sealed, sequentially numbered, opaque envelopes. |
Blinding (performance bias and detection bias) Participants |
High risk | Different interventions. |
Blinding (performance bias and detection bias) Clinical staff |
High risk | Different interventions. |
Blinding (performance bias and detection bias) Outcome assessor |
High risk | Different interventions. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | Small loss to follow up but very low recruitment to this study |
Other bias | Unclear risk | Of 304 women informed of the study, only 35 were recruited. |