Does Scar Massage Improve Postoperative Pain and Function in Women With Breast Cancer?
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|ClinicalTrials.gov Identifier: NCT00175344|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Scar massage.||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.|
|Study Start Date :||February 2004|
|Primary Completion Date :||April 2006|
|Study Completion Date :||April 2006|
Arm A: Self-administered massage of the postoperative scar after breast cancer surgery.
Procedure: Scar massage.
To objectively evaluate the effects of scar massage, those who agree to participate will be randomly assigned to one of two groups. One group will be taught to perform self-massage of the scars as soon as the scars have adequately healed. The massage should be done about 10 minutes each day for a total of 6 months. The other group will not be taught self-massage and will be asked to not massage their breast scars.
- The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form). [ Time Frame: Two years ]
- 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 [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175344
|Canada, British Columbia|
|BC Cancer Agency - Vancouver Island|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator:||Pauline Truong, MD||University of British Columbia|