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

García‐Pérez 2018.

Methods Design: 2‐month prospective randomised controlled study
Participants Health condition: elderly people with pressure ulcers
Sample size:

  • Randomisation: at ulcer level

  • Randomised (ulcers, n): 17

    • Experimental: 9

    • Control: 8

  • Analysed (ulcers, n): 15

    • Experimental: 8

    • Control: 7


Setting, country: nursing homes (6 sites), Spain
Inclusion criteria:

  • participants older than 50 years

  • participants with pressure ulcer on the distal third of their lower limb

  • participants at risk of presenting a pressure ulcer (Norton Scale)

  • participants with stage II, III and IV pressure ulcer (EPUAP classification and Grupo Nacional para el Estudio y Asesoramiento en Ulceras por Presion classification)

  • participants with minimal or no improvement following standard wound care

  • participants with poor nutritional state (Mini Nutritional Assessment scale) or a severe problem with functioning adequately (Functional Independence Measure)

  • Participants with cognitive impairment (Spanish Mini‐Mental State Examination)


Exclusion criteria:

  • participants with arterial insufficiency

  • participant for whom TENS therapy was contraindicated

  • participants with diabetic foot ulcers


Characteristics of pressure ulcer:

  • Overall

    • Ulcer duration, mean (SD): 5.23 months (3.6)

    • Ulcer location (n; %): heel (13; 76), peroneal malleolus (3; 18), lateral side of the foot (1; 6)

  • Experimental

    • Ulcer duration, mean (SD): not reported

    • Ulcer location (n; %): not reported

    • Ulcer stage (n): stage II (1), stage III (7) and stage IV (1)

  • Control

    • Ulcer duration, mean (SD): not reported

    • Ulcer location (n; %): not reported

    • Ulcer stage (n): stage II (5), stage III (3)


Mean age (SD):

  • Overall: 81 years (7)

  • Experimental: 81 years (8)

  • Control: 81 years (6)


Gender:

  • Overall: 32% male (out of total 22 participants screened)

  • Experimental: not reported

  • Control: not reported
Interventions Total groups in this study: two
Experimental: TENS and standard wound care

  • Duration: 60 minutes per session; 20 sessions in 2 months

  • Electrode placement: four electrodes were placed around the ulcer

  • Device, manufacturer: TENS device, S82 electrostimulator TensMed; Enraf Nonius, Bizkaia, Spain

  • Intensity of ES: tingling sensation but with no motor effects

  • Frequency: 40 Hz

  • Type of current: pulsed

  • Polarity: not reported


Control: standard wound care
Standard wound care for both groups

  • This included cleaning of the wound with soap and saline solution, applying absorbent wound dressings (AQUACEL Ag Extra; ConvaTec, Greensboro, North Carolina) and antibacterial ointment (Silvederma or Furacın; Aldo‐Union, Barcelona, Spain). For necrotic wounds, a hydrogel for pressure injury debridement (Intrasite, Smith & Nephew, San Antonio, Texas) or Iruxol (Intekom, Lubliniec, Poland) was used and was secured with a dressing (gauge and bandages). This protocol was followed for a 2‐month period, comprising a total of 20 sessions (3 times per week).
Outcomes Outcomes included in this review: presented as [name of outcome in review] – [name of outcome in study]

  • Surface area of pressure ulcers ‐ area of ulcer (expressed as cm2)

  • Composite measure of pressure ulcer severity ‐ pressure injury healing rate (assessed using Resultados Esperados de la Valoracion y Evolucion de la Cicatrizacion de las Heridas cronicas (RESVECH) index)

  • Complications/adverse events ‐ adverse event


Other outcomes not included in this review:

  • Blood flow

  • Skin temperature

  • Oxygen saturation

  • Pain


Time point included in this review: 2 months (end of intervention)
Notes Withdrawals, (n; reason):

  • Experimental: 1; loss to follow‐up

  • Control: 1; loss to follow‐up


Funding source: no funding
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) Low risk Quote: “The physical therapist who examined the participants for eligibility and collected baseline demographic data prepared the randomization code using computer software.” p464
Allocation concealment (selection bias) High risk Quote: " The physical therapist who examined the participants for eligibility and collected baseline demographic data prepared the randomization code using computer software.
This research assistant was not involved in the rest of the study. Treatment allocation was concealed……” p464
Blinding of participants (performance bias) 
 All outcomes High risk Comment: not possible to blind participants
Blinding of personnel (performance bias) 
 All outcomes High risk Comment: not possible to blind personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “…physical therapists who collected all outcome measures at baseline and after 20 sessions of treatment were blinded to treatment assignment.” p464
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: 2/17 (12%) dropouts
Selective reporting (reporting bias) Low risk Comment: all pre stated outcomes were reported
Other bias Low risk Comment: appears free of other bias