Adegoke 2001.
Methods | Design: 4‐week single‐centred, parallel randomised controlled study | |
Participants |
Health condition: people with spinal cord injury Sample size:
Setting, country: neurology wards at the University College Hospital (1 site), Nigeria Inclusion criteria:
Exclusion criteria: not reported Characteristics of pressure ulcer:
Mean age (SD):
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. |
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Interventions |
Total groups in this study: two Experimental: interrupted direct current and standard nursing care
Control: placebo interrupted direct current and standard nursing care
Standard nursing care for both groups
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Outcomes |
Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]
Not useable data: presented as [name of outcome in review]‐ [name of outcome in study]
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 |
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Notes |
Withdrawals, (n; reason):
Funding source: no information about funding source provided Trial registration or published protocol: no information about trial registration or published protocol provided |
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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 |