OBJECTIVE: The current placebo-controlled study was undertaken to investigate the efficacy of combined phototherapy and low-intensity laser therapy (LILT) in the management of chronic venous ulceration when used in conjunction with standardized nursing intervention. MATERIALS AND METHODS: Approval was granted by Research Ethical Committees at the University of Ulster and Altnagelvin Hospitals Health and Social Services Trust. Patients (n = 15; 10 female/5 male; age +/- SD = 69.9 +/- 13.8 years) were recruited from an outpatient "leg ulcer clinic," where they attended once per week for irradiation/sham treatments for 4 weeks. Treatment was withheld for a total of 8 weeks, and patients were reviewed during this time (weeks 8 and 12) for ulcer and pain assessment only. A multisource diode array (660-950 nm) was used for irradiation; parameters were kept constant for the duration of the study (532 mW; 5 kHz; 12 J/cm(2)). Wound and pain assessment were carried out by an independent investigator. Digitizing was used to quantify surface areas from wound tracings. RESULTS: Although there was no statistically significant difference between Treatment and Placebo groups, an apparent clinical difference in wound healing rate was noted; at postirradiation, a continued reduction in wound size was evident for the treatment group. These effects were believed to be due to an apparent delayed effect. There was no statistically significant difference between groups for pain. CONCLUSION: These findings provide only limited evidence for the use of this modality as an adjunctive therapy with current nursing intervention. Further group studies are indicated to investigate the apparent delayed effect reported here for various etiologies of ulceration.
RCT Entities:
OBJECTIVE: The current placebo-controlled study was undertaken to investigate the efficacy of combined phototherapy and low-intensity laser therapy (LILT) in the management of chronic venous ulceration when used in conjunction with standardized nursing intervention. MATERIALS AND METHODS: Approval was granted by Research Ethical Committees at the University of Ulster and Altnagelvin Hospitals Health and Social Services Trust. Patients (n = 15; 10 female/5 male; age +/- SD = 69.9 +/- 13.8 years) were recruited from an outpatient "leg ulcer clinic," where they attended once per week for irradiation/sham treatments for 4 weeks. Treatment was withheld for a total of 8 weeks, and patients were reviewed during this time (weeks 8 and 12) for ulcer and pain assessment only. A multisource diode array (660-950 nm) was used for irradiation; parameters were kept constant for the duration of the study (532 mW; 5 kHz; 12 J/cm(2)). Wound and pain assessment were carried out by an independent investigator. Digitizing was used to quantify surface areas from wound tracings. RESULTS: Although there was no statistically significant difference between Treatment and Placebo groups, an apparent clinical difference in wound healing rate was noted; at postirradiation, a continued reduction in wound size was evident for the treatment group. These effects were believed to be due to an apparent delayed effect. There was no statistically significant difference between groups for pain. CONCLUSION: These findings provide only limited evidence for the use of this modality as an adjunctive therapy with current nursing intervention. Further group studies are indicated to investigate the apparent delayed effect reported here for various etiologies of ulceration.
Authors: Cláudia Patrícia Cardoso Martins Siqueira; Solange de Paula Ramos; Cynthia A A Gobbi; Leonardo Shigaki; Roberto K Kashimoto; Emerson José Venâncio; Dari de Oliveira Toginho Filho; André G Castaldin; Alan S Felinto; Francisco Pereira Silva; Ricardo B Silva; Ivan Frederico Lupiano Dias Journal: Lasers Med Sci Date: 2014-10-15 Impact factor: 3.161