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| ID | Type | Description | Link |
|---|---|---|---|
| PMR-2017-26231 | Other Identifier | University of Minnesota Masonic Cancer Center |
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Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=200) Phase 2: This is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with AWS following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). Funding to progress to Phase 2 of this trial has been obtained. It is anticipated 120 subjects participating in Phase 1 will be screened for eligibility for Phase 2 (separate consent and eligibility from Phase 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patient will not receive physical therapy treatment or further instruction from the research team. The patient will receive standard care recommended by their medical provider which may or may not include physical therapy treatment. | |
| Physical Therapy Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy: Dependent on Patient's Needs | Behavioral | Therapeutic exercise:
Lymphedema treatment
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical characteristics of preoperative Auxillary Web Syndrome (AWS) | Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not) | 1 Year |
| Treatment Effects | Range of motion (ROM) will be measured using a standard goniometer | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | Measured by 0-10 scale and Penn Shoulder Score questionaire | 1 Year |
| Function | Disabilities of the Arm, Shoulder and Hand questionaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Koehler, PhD, PT, CLT-LANA | University of Minnesota, Division of Physical Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 1 Year |
| Lymphedema | Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy | 1 Year |
| Physical activity | Measured by International Physical Activity Questionaire IPAQ (short form) | 1 Year |
| Axillary web syndrome status | (present/not present) based on palpable assessment by investigator | 1 Year |
| Preoperative AWS and a positive lymph node status | Correlation between AWS and a positive lymph node status | 1 Year |
| Abduction range of motion (ROM) | ROM measured by a standard goniometer | 1 month |
| DASH Score | Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire | 1 Month |
| Body mass index (BMI) | Difference in body mass index (BMI) between patients with and without AWS (pre and post operative) | 1 month |
| D017437 |
| Skin and Connective Tissue Diseases |