Efficacy of decongestive and pressotherapy in patients with lymphedema of the arm after breast cancer treatment

UVOD. Sekundarni limfedem ruke je relativno česta komplikacija nakon lečenja raka dojke. Iako se kompleksna dekongestivna terapija smatra “zlatnim standardom“ ", još uvek postoji kontroverza o tome da li dodavanje presoterapije daje bolji terapijski efekat. Stoga je cilj ovog istraživanja bio uporediti efikasnost kompleksne dekongestivne fizikalne terapije (KDFT) u odnosu na kompleksnu dekongestivnu fizikalnu terapiju sa presoterapijom na funkcionalni status, nivo bola i kvalitet života kod pacijentkinja sa sekundarnim limfedemom ruke nakon lečenja raka dojke. MATERIJAL I METODE. Prospektivna, randomizovana, paralelna, nemaskirana studija je obuhvatila 108 pacijentkinja sa sekundarnim limfedemom ruke, prosečne starosti 56,8 ± 8,5 godina, koje su završile operativno lečenje raka dojke pre 57,4 ± 46,2 meseca. One su randomizovane u 2 grupe: KDFT grupa (kontrolna) ili KDFT+presoterapija grupa (eksperimentalna). Protokol KDFT se sastojao od nege kože, manuelne limfne drenaže, kratkoelastične višeslojne bandaže i vežbi. Osim toga, eksperimentalna grupa je primala presoterapiju (intermitentnu pneumatsku kompresiju), 30 minuta dnevno pri pritisku od 40 mm Hg. Oba protokola su se provodila jednom dnevno, pet dana sedmično tokom 3 sedmice. Ispitanice su podučavane za nastavak samostalnog sprovođenja nege kože, manuelne limfne drenaže i vežbi, kao i za nošenje kompresivnog rukava, 3 meseca nakon završetka lečenja. Mere ishoda. Obim ruke, obim pokreta u zglobu ramena, snaga stiska šake, vizuelna analogna skala za bol, upitnik Nesposobnost ruke, ramena i šake (DASH) za funkciju ruke i upitnik Funkcionalna analiza lečenja raka dojke dojke sa subskalom 4+ za ruku (FACT-B4+) za kvalitet života su ocenjeni pre, neposredno nakon i 3 meseca nakon završetka lečenja. Za statističku obradu dobijenih podataka korišćene su deskriptivne metode, analiza varijanse (ANOVA) za ponovljena merenja, analiza kovarijanse, Man-Vitni test, hi-kvadrat test i Fišerov egzaktni test, prema potrebi. REZULTATI. Od ukupno 108 randomizovanih ispitanica, analizirane su 102 (51 u svakoj grupi). Nije bilo značajnih razlika u demografskim i kliničkim karakteristikama između dve grupe. ANOVA je pokazala značajan uticaj vremena za sve ispitivane varijable (p <0,01), ali ne i značajnu interakciju vreme-grupa (0,07 ≤ p ≤ 0,99). Tačnije, nije bilo značajne razlike između dve ispitivane grupe u stepenu smanjenja limfedema, obimu pokreta u ramenu, snazi stiska šake, nivou bola, DASH skoru i skorovima kvaliteta života merenim FACT -B4+, na kraju tretmana, i nakon 3 meseca praćenja. ZAKLJUČAK. Dodavanje presoterapije kompleksnoj dekongestivnoj terapiji, ne doprinosi boljem ishodu lečenja kod pacijentkinja sa limfedemom ruke nakon operacije karcinoma dojke u poređenju sa samo dekongestivnom terapijom.BACKGROUND. Secondary lymphedema of the arm is a relatively common complication after breast cancer surgery. Although complex decongestive therapy is considered the “golden standard”, there is still a controversy as to whether adding pressotherapy is of any value. Thus, the aim of this study was to compare the efficacy of complex decongestive therapy (CDT) against complex decongestive therapy combined with a pressotherapy on functional status, pain, and quality of life in patients with secondary lymphedema of the arm after breast cancer treatment. METHODS. In this prospective, randomized, parallel, non-blind study, we recruited 108 women, mean age 56.8±8.5 years, with secondary arm lymphedema who completed breast cancer surgery 57.4±46.2 months earlier. They were randomly assigned to a CDT group (control) or CDT+pressotherapy group (experimental). The CDT protocol consisted of skin care, manual lymphatic drainage, short stretch multi-layer compression bandages, and exercises provided by therapists. In addition to that, the experimental group received pressotherapy (intermittent pneumatic compression) for 30 minutes per day at a pressure of 40 mmHg. The treatments were administered once a day, five days a week, for 3 weeks. The subjects were instructed to continue administering the skin care, manual lymphatic drainage, compression sleeve and exercises on their own for 3 months after the end of treatment. Outcome measures. Arm circumference, shoulder range of motion, grip strength, visual analog scale for pain, Disability of the Arm, Shoulder and Hand questionnaire (DASH) for the overall arm function, and Functional Analysis of Cancer Treatment- Breast 4+ (FACT-B4+) for quality of life were assessed before, immediately after, and at 3 months after the end of treatment. The statistical analyses included descriptive methods, analysis of variance (ANOVA) for repeated measures, analysis of covariance, Mann-Whitney U- test, chi-square test, and Fisher’s exact test, as appropriate. RESULTS. From a total of 108 subjects randomly assigned, 102 completed the entire protocol (51 in each group), and their data were analyzed. There were no significant differences in demographic and clinical characteristics between the two groups. The ANOVA revealed significant main effect of Time for all studied variables (p < 0.01), but no significant group-by-time interaction (0.07 ≤ p ≤ 0.99). More specifically, there was no significant difference between the two groups in the degree of lymphedema reduction, shoulder range of motion, grip strength, pain, DASH score, and FACT-B4+ scores either at the end of treatment or at 3-month follow up. CONCLUSIONS. Combining CDT with pressotherapy is no more efficacious than providing CDT alone in patients who present with chronic arm lymphedema after completing breast cancer treatment