Ekdahl 2010.
Methods | 40 pregnant women 'from the same demographic area' in Sweden; N = 20 in each group (group 1 and 2). After diagnosis with pelvic and LBP, women were referred to the acupuncturist at the hospital 'where randomisation was carried out; women were phoned to give them the dates for their acupuncture; baseline data were collected when they came for treatment'. |
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Participants |
Inclusion criteria:
Exclusion criteria:
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Interventions | Both groups received the same treatment; 8 acupuncture treatments over a 6‐week period (2 treatments per week in the first 2 weeks and once per week thereafter) with first treatment lasting 20 minutes and number of needles limited to 5, and remainder 30 minutes with maximum 10 needles. Intervention group 1 (N = 20/16 analysed): mean age 28.6 years, started treatment at 20 weeks' gestation and Intervention group 2 (N = 20/16 analysed): mean age 27.9 years, started treatment at 26 weeks' gestation. No control group: acupuncture intervention was started either at 20 (group 1) or 26 weeks' (group 2) gestation. |
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Outcomes | Short Form Health survey questionnaire (SF‐36), Short Form Magill Pain Questionnaire (MPQ), Pain‐o‐meter, fetal sound measured at baseline, at 4th and 8th treatment sessions, at same times for each group; qualitative data collected via telephone interviews 2 to 3 months after delivery. Both groups had similar experience of acupuncture (from qualitative interviews). Small number of study participants acknowledged by authors. Non compliance in both groups reported. |
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Condition (LBP, PP, LBPP) | LBPP. | |
Notes | Funding = Council of Research and Development (FoU‐centrum), Landstinget Kronoberg, Sweden. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information given about sequence generation; in the discussion it states that 'the women were chosen randomly'. |
Allocation concealment (selection bias) | Low risk | Telephone allocation. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | 'both groups had similar experience with acupuncture when asked at end of treatment'; unclear if acupuncturists were informed of gestation, or if they were able to determine by observation, however, the difference was only 20 to 26 weeks, therefore likely not a big issue. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information provided on who collected the self‐report outcomes. |
Incomplete outcome data (attrition bias) effect of intervention | Low risk | Both groups had 4 drop‐outs with reasons given ‐ did not appear to be related to intervention. |
Selective reporting (reporting bias) | Low risk | Qualitative data supports quantitative data ‐ however the telephone interviews were completed by the study author. |
Other bias | Low risk | Co‐interventions and adherence similar across groups, timing of outcome assessment same across groups, mean pain intensity was significantly lower in group 1 than group 2 at baseline. |