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Physical therapies in the decongestive treatment of lymphedema: a randomized, non-inferiority controlled study [with consumer summary]
Forner-Cordero I, Munoz-Langa J, de Miguel-Jimeno JM, Rel-Monzo P
Clinical Rehabilitation 2021 Dec;35(12):1743-1756
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; 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 assess whether the treatment with intermittent pneumatic compression plus multilayer bandages is not inferior to classical trimodal therapy with manual lymphatic drainage in the decongestive lymphedema treatment. STUDY DESIGN: Randomized, non-inferiority, controlled study to compare the efficacy of three physical therapies' regimens in the decongestive lymphatic therapy. PARTICIPANTS: 194 lymphedema patients, stage II to III with excess volume > 10% were stratified within upper and lower limb and then randomized to one of the three treatment groups. Baseline characteristics were comparable between the groups. INTERVENTION: all patients were prescribed 20 sessions of the following regimens: group A (control group): manual lymphatic drainage plus intermittent pneumatic compression plus bandages; group B: pneumatic lymphatic drainage plus intermittent pneumatic compression plus bandages; and group C: only intermittent pneumatic compression plus bandages. END-POINT: Percentage reduction in excess volume (PREV). RESULTS: All patients improved after treatment. Global mean of PREV was 63.9%, without significant differences between the groups. The lower confidence interval of the mean difference in PREV between group B and group A, and between group C and group A were below 15%, thus meeting the non-inferiority criterion. Most frequent adverse events were discomfort and lymphangitis, without differences between groups. A greater baseline edema, an upper-limb lymphedema and a history of dermatolymphangitis were independent predictive factors of worse response in the multivariate analysis. CONCLUSIONS: Decongestive lymphatic therapy performed only with intermittent pneumatic compression plus bandages is not inferior to the traditional trimodal therapy with manual lymphatic drainage. This approach did not increase adverse events.

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