Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.
This is a prospective randomized controlled trial design. Women who have undergone breast
cancer surgery (breast conserving surgery or mastectomy) and who meet the eligibility
criteria specified will be offered study participation. After obtaining informed consent,
subjects will be randomized between two cohorts: scar massage (intervention group) versus
no scar massage (control group). The primary outcome is scar-related pain (scored using the
McGill Pain Questionnaire Short Form). The secondary outcomes are: upper body range of
motion, physical parameters of the scar (pliability, scar height, vascularity and
pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm
circumference measurements) and quality of life (using the Functional Assessment of Cancer
Therapy (FACT)-B breast cancer-specific instrument).
A sample size of 143 patients per arm was estimated to detect a 30% difference in the
primary outcome of postoperative scar-related pain between the intervention and the control
groups with 80% statistical power.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).
Pauline Truong, MD
University of British Columbia
Canada: Health Canada