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| Randomized control of extracorporeal shock wave therapy versus placebo for chronic decubitus ulceration [with consumer summary] |
| Larking AM, Duport S, Clinton M, Hardy M, Andrews K |
| Clinical Rehabilitation 2010 Mar;24(3):222-229 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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OBJECTIVE: To assess whether extracorporeal shock wave therapy increases the rate of healing in chronic decubitus ulceration. DESIGN: Double-blind randomized cross-over study. SETTING: A large, long-stay hospital specializing in the management of people with complex neurological disabilities. SUBJECTS: The total population of available patients with chronic neurological conditions and chronic decubitus ulceration who met the inclusion criteria. INTERVENTIONS: Ulcers were randomized into receiving either the extracorporeal shock wave therapy or the placebo for a four-week period, followed by a two-week 'washout' period followed by a four-week period of the cross-over treatment/placebo. MAIN MEASURES: Measurement of the area of the ulceration. For each observation the average of three measurements were taken. RESULTS: Nine ulcers (in eight patients) were included in the study: five on the buttocks/sacrum/trochanter and four on the feet/ankles. All those with static chronic ulcers showed improved healing starting 6 to 8 weeks after the start of extracorporeal shock wave therapy, whether treated first with the placebo or the therapy. CONCLUSIONS: Extracorporeal shock wave therapy has a potential part to play in the treatment of chronic skin ulceration.
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