| Methods | Trial design: single blind randomised controlled clinical trial. Randomisation and allocation: allocation was by a random number generator and block 2 design without stratification. Blinding: no details on blinding. Number of participants: 30 women randomised, 26 analysed;1 from treatment group and 3 from sham group dropped out or lost to follow up. | |
| Participants | Inclusion: had a history of primary dysmenorrhoea for at least 1 year, menstrual pain beginning day before or just after onset of menstrual flow, moderate to severe pain, regular cycle. Exclusion: over age 50 years; history of endometriosis, pelvic inflammatory disease, or other pelvic organic pathology; using IUD; also needed to refrain from other chiropractic care during the course of the study. Age: means 26.1(4.5) and 27.1(6.2) years. | |
| Interventions | Treatment: Toftness system of chiropractic adjusting, low force technique which uses a sensometer to detect electromagnetic radiation and determine which sites to adjust. Control: same procedure however adjustments made at a site distinct from that identified by the sensometer. Duration: 3 consecutive cycles, adjustments began on day 1 of menstrual flow and received daily until last day of menstrual flow, no more than 27 adjustments in the 90 day treatment period. Then women monitored for 3 months after treatment. If loss of pain experienced after first cycle no more adjustments were given, if pain exacerbated women were dropped from the trial. | |
| Outcomes | MDQ completed on first day of every cycle: 5‐point scale for 18 questions. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Randomisation was by a random number generator and block 2 design without stratification |
| Allocation concealment? | Unclear risk | B‐unclear |
| Blinding? All outcomes | High risk | No evidence of blinding |
| Incomplete outcome data addressed? All outcomes | Low risk | 26 analysed,1 from treatment group and 3 from sham group dropped out or lost to follow up |
| Free of selective reporting? | Low risk | All relevant outcomes reported |
LFM: low‐force mimic manoeuvre
MDQ: Menstrual Distress Questionnaire
SMT: spinal manipulative therapy
VAS: visual analogue scale