Laser therapy does not work for capsular contracture: A randomised controlled trial.
Association of Breast Surgery ePoster Library. Azimi F. 05/15/17; 166337; P078
Farhad Azimi
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Abstract
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Introduction: Low level laser (LLL) is a modality that has been widely used to promote tissue healing, reduce scarring and treat inflammatory/circulatory disorders and has been successfully used to treat breast cancer-related lymphoedema. A phase one, non-randomised clinical trial has previously demonstrated efficacy for LLL in treatment of Grade III/IV capsular contracture. The objective of this study was to determine if LLL can improve the signs and symptoms of capsular contracture following expander/implant reconstruction.
Methods: A prospective, double blinded, randomised, placebo controlled trail of 40 women (mean age 50), with Grade I- Grade IV capsular contracture. Twenty women were randomly allocated to either the control arm (treatment with an inactive Laser) or to the treatment arm (treatment with an active Laser). Treatment occurred weekly over a six week period, with patient and clinician reported outcomes collected at baseline, five weeks, one month post-treatment and six months post-treatment. This project was approved by the Human Research Ethics Committee, St Vincent's Hospital, Sydney, NSW, Australia.
Results: There were no significant differences in treatment outcomes following Laser treatment as assessed by both patients and clinicians. While there was non-significant improvement over time for both groups, the inactive Laser delivered better outcomes overall and in the majority of domains and time points.
Conclusions: This small RCT demonstrated no significant improvement in women treated with the active laser. This unexpected result revealed a strong placebo effect where nine of 20 women who did not receive active treatment believed their symptoms had improved.
Methods: A prospective, double blinded, randomised, placebo controlled trail of 40 women (mean age 50), with Grade I- Grade IV capsular contracture. Twenty women were randomly allocated to either the control arm (treatment with an inactive Laser) or to the treatment arm (treatment with an active Laser). Treatment occurred weekly over a six week period, with patient and clinician reported outcomes collected at baseline, five weeks, one month post-treatment and six months post-treatment. This project was approved by the Human Research Ethics Committee, St Vincent's Hospital, Sydney, NSW, Australia.
Results: There were no significant differences in treatment outcomes following Laser treatment as assessed by both patients and clinicians. While there was non-significant improvement over time for both groups, the inactive Laser delivered better outcomes overall and in the majority of domains and time points.
Conclusions: This small RCT demonstrated no significant improvement in women treated with the active laser. This unexpected result revealed a strong placebo effect where nine of 20 women who did not receive active treatment believed their symptoms had improved.
Introduction: Low level laser (LLL) is a modality that has been widely used to promote tissue healing, reduce scarring and treat inflammatory/circulatory disorders and has been successfully used to treat breast cancer-related lymphoedema. A phase one, non-randomised clinical trial has previously demonstrated efficacy for LLL in treatment of Grade III/IV capsular contracture. The objective of this study was to determine if LLL can improve the signs and symptoms of capsular contracture following expander/implant reconstruction.
Methods: A prospective, double blinded, randomised, placebo controlled trail of 40 women (mean age 50), with Grade I- Grade IV capsular contracture. Twenty women were randomly allocated to either the control arm (treatment with an inactive Laser) or to the treatment arm (treatment with an active Laser). Treatment occurred weekly over a six week period, with patient and clinician reported outcomes collected at baseline, five weeks, one month post-treatment and six months post-treatment. This project was approved by the Human Research Ethics Committee, St Vincent's Hospital, Sydney, NSW, Australia.
Results: There were no significant differences in treatment outcomes following Laser treatment as assessed by both patients and clinicians. While there was non-significant improvement over time for both groups, the inactive Laser delivered better outcomes overall and in the majority of domains and time points.
Conclusions: This small RCT demonstrated no significant improvement in women treated with the active laser. This unexpected result revealed a strong placebo effect where nine of 20 women who did not receive active treatment believed their symptoms had improved.
Methods: A prospective, double blinded, randomised, placebo controlled trail of 40 women (mean age 50), with Grade I- Grade IV capsular contracture. Twenty women were randomly allocated to either the control arm (treatment with an inactive Laser) or to the treatment arm (treatment with an active Laser). Treatment occurred weekly over a six week period, with patient and clinician reported outcomes collected at baseline, five weeks, one month post-treatment and six months post-treatment. This project was approved by the Human Research Ethics Committee, St Vincent's Hospital, Sydney, NSW, Australia.
Results: There were no significant differences in treatment outcomes following Laser treatment as assessed by both patients and clinicians. While there was non-significant improvement over time for both groups, the inactive Laser delivered better outcomes overall and in the majority of domains and time points.
Conclusions: This small RCT demonstrated no significant improvement in women treated with the active laser. This unexpected result revealed a strong placebo effect where nine of 20 women who did not receive active treatment believed their symptoms had improved.
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