Nabi 2021.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline, 4 weeks, post‐intervention Country: Iran |
|
Participants | Pain condition: painful diabetic neuropathy Population: adults with type I or type II diabetes and a diagnosis of diabetic peripheral neuropathic pain Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 72 Age in years (mean, SD): 57.71 (7.43) Gender: 29/72 were female Pain duration in months (mean, SD): 22.46 (9.52) |
|
Interventions | TENS
Duloxetine ‐ 60 mg
|
|
Outcomes | Pain intensity AEs Withdrawal |
|
Missing data methods | Completer analysis only ‐ 12 participants discontinued treatment due to intolerability and were replaced with new cases. | |
Funding source | Study was not financially supported | |
Conflicts of interest | The study authors reported no conflicts of interest. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using http://www.graphpad.com/quickcalcs/index.cfm. |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to be blinded due to the nature of TENS |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes from unblinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis only. 12 participants dropped out, all in the duloxetine arm due to side effects. Participants who dropped out were replaced with new participants, and their data not analysed. Attrition Total: 12/72 (16.7%) TENS: 0/30 (0.0%) Duloxetine 60 mg: 12/42 (28.6%) |
Selective reporting (reporting bias) | Low risk | Trial registered prospectively and outcomes match |
Other bias | Low risk | No other sources of bias were identified. |