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. 2020 Jan 22;2020(1):CD012196. doi: 10.1002/14651858.CD012196.pub2

Adegoke 2001.

Methods Design: 4‐week single‐centred, parallel randomised controlled study
Participants Health condition: people with spinal cord injury
Sample size:
  • Randomisation: at participant level (1 ulcer per participant)§

  • Randomised (participants, n; ulcers, n): 7; 7

    • Experimental: 4; 4

    • Control: 3; 3

  • Analysed (participants, n; ulcers, n): 6; 6

    • Experimental: 3; 3

    • Control: 3; 3


Setting, country: neurology wards at the University College Hospital (1 site), Nigeria
Inclusion criteria:
  • inpatients with spinal cord injury

  • stage IV pressure ulcers (DeLisa classification)

  • pressure ulcers on the pelvic region


Exclusion criteria: not reported
Characteristics of pressure ulcer:
  • Experimental

    • Ulcer duration, mean (SD): 12 weeks (2)

    • Ulcer location (n): greater trochanter (2), sacrum (1)

    • Ulcer stage (%): stage IV (100)

  • Control

    • Ulcer duration, mean (SD): 8 weeks (2)

    • Ulcer location (n): greater trochanter (1), sacrum (2)

    • Ulcer stage (%): stage IV (100)


Mean age (SD):
  • Overall: 44 years (14)

  • Experimental: 53 years (8)

  • Control: 35 years (14)


Gender: not reported
§It is not clearly stated whether participants or pressure ulcers were randomised but the number of pressure ulcers equals the number of participants.
Interventions Total groups in this study: two
Experimental: interrupted direct current and standard nursing care
  • Duration: 45 minutes per session; 3 sessions per week; total 4 weeks

  • Electrode placement: one over the ulcer and the other over any suitable part of the body

  • Device, manufacturer: Interrupted Direct Current machine, Duffield Medical Equipment Ltd. UK

  • Intensity of ES: gradually increased until a minimal perceptible contraction was seen

  • Frequency: 30 Hz

  • Type of current: direct

  • Polarity: not reported


Control: placebo interrupted direct current and standard nursing care
  • Same settings and duration as experimental group, but without current


Standard nursing care for both groups
  • Not reported

Outcomes Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]
  • Surface area of pressure ulcers‐ surface area (expressed as mm2)*


Not useable data: presented as [name of outcome in review]‐ [name of outcome in study]
  • Rate of pressure ulcer healing‐ percentage change in surface area (expressed as percentage per 2 week)†


Time point included in this review: week 4 (end of intervention)
Other time points: baseline and week 2
*converted to cm2 for the purpose of analyses
†SD not provided
Notes Withdrawals, (n; reason):
  • Experimental: 1; early discharge from the hospital

  • Control: none


Funding source: no information about funding source provided
Trial registration or published protocol: no information about trial registration or published protocol provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Subjects were then randomly assigned to either group A (IDC plus nursing care) or group B (placebo IDC plus nursing care)." p195
Comment: insufficient detail reported
Allocation concealment (selection bias) Low risk Quote: "The assignment to groups was done by an individual with no knowledge of the treatment modality as a way of reducing investigator bias." p195
Blinding of participants (performance bias) 
 All outcomes Low risk Comment: control participants received placebo interrupted direct currents
Blinding of personnel (performance bias) 
 All outcomes High risk Comment: not possible to blind personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "All measurements were taken by the same therapist (BKA) to ensure reliability." p196
 Comment: insufficient detail reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "One of the patient[s] requested to be discharged from the hospital before the end of the study hence was not regarded as being part of the study leaving three subjects each in both groups….." p196
Comment: 1/7 (14%) dropouts
Selective reporting (reporting bias) Low risk Comment: all pre stated outcomes were reported
Other bias Low risk Comment: appears free of other bias