| Methods |
Randomised ‐ method unstated in published trial. Communication from author stated it was a centralised randomisation process
Double blind ‐ for type of TENS intervention
Crossover design
32 women randomised and analysed
Communication from author states that intention‐to‐treat analysis and a power calculation were used however no details were provided |
| Participants |
Inclusion: severe primary dysmenorrhoea (diagnosed according to "predefined clinical criteria", regular cycles)
Exclusion: OCP use
Age: mean 28.5 (5.2) years
Location: USA |
| Interventions |
1. Ibuprofen 400 mg every 6 hrs for 3 days
2. High‐frequency TENS (conventional) ‐ 100 pulses/sec, 100 μsec pulse width, amplitude comfortable tingling
3. Placebo TENS
Location: abdomen (portable unit)
Duration: first 8hrs of cycle, then when needed for pain relief
5 cycles ‐ TENS 2 cycles, placebo TENS 1 cycle, ibuprofen 1 cycle (sequence random) |
| Outcomes |
Pain relief ‐ scale 1‐5
Menstrual symptom questionnaire
Use of pain medication |
| Notes |
Author supplied some unpublished methodological information
No information or baseline comparison on the groups pain characteristics |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
"..enrolled in a randomized crossover study" ‐ method unstated in published trial. |
| Allocation concealment? |
Low risk |
No details provided. Communication from author stated it was a centralised randomisation process. |
| Blinding?
All outcomes |
Low risk |
Double blind ‐ for type of TENS intervention. "subjects and investigators were blinded as to the type of transcutaneous electrical nerve stimulator..." |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
All patients followed up, no apparent drop outs. |
| Free of selective reporting? |
Low risk |
All relevant outcomes reported. |
