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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

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
  • Diabetic peripheral neuropathic pain for at least 6 months diagnosed according to the MNSI scale

  • Pain intensity of ≥ 4 on 0‐10 scale


Exclusion criteria
  • Hepatic, heart, or renal failure; uncontrolled hypertension; psychological disorders; epilepsy; other neuropathies


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
  • n = 30

  • TENS

  • For 4 weeks, sessions every other day. Then, twice a week for 3 months


Duloxetine ‐ 60 mg
  • n = 42

  • SNRI

  • Fixed dose with forced titration

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.