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The effects of non-thermal pulsed electromagnetic energy (Diapulse) on wound healing of pressure ulcers in spinal cord-injured patients: a randomized, double-blind study |
Salzberg CA, Cooper-Vastola SA, Perez FJ, Viehbeck MG, Byrne DW |
Wounds 1995 Jan-Feb;7(1):11-16 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: Yes; Blind therapists: Yes; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine if Diapulse treatment significantly increases the healing rate of pressure ulcers in patients with spinal cord injuries. DESIGN: Randomized, double-blind study with a follow-up period of 12 weeks or until healed. SETTING: Population consisted of volunteers admitted to a Veterans Administration Hospital in New York state over a two year period. PATIENTS: Thirty male spinal cord-injured patients, 20 with stage II and 10 with stage III pressure ulcers. INTERVENTION: Non-thermal, pulsed, high-frequency, electromagnetic energy (Diapulse) treatment for 30 minutes twice daily for 12 weeks or until healed. MAIN OUTCOME MEASURE: Percent of pressure ulcer healed at one week. RESULTS: Of the 20 patients with stage II pressure ulcers, the active Diapulse group had a significantly increased rate of healing with a greater percent of the ulcer healed at one week than the control group (84.0% versus 40.0%, p = 0.010). After controlling for the baseline status of the pressure ulcer, active Diapulse treatment was independently associated with a significantly shorter median time to complete healing of the ulcer (13.0 versus 31.5 days, p = 0.002). Stage III pressure ulcers healed faster in the Diapulse treatment group but the sample size was limited. CONCLUSION: For spinal cord-injured men with stage II pressure ulcers, active Diapulse treatment significantly improved healing.
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