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Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .
Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.
There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.
Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.
Hypotheses
Methods
Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel
Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast surgery and exercise | Active Comparator | Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge. |
|
| Breast surgery and no exercise | Active Comparator | Patient after breast surgery alone are discharged without exercise and instructions. |
|
| Breast, axilar surgery with exercise | Active Comparator | Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge. |
|
| Breast, axillar surgery without exercise | Active Comparator | The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHYSICAL THERAPY | Other | EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain | The intensity of pain and chronological modification will be monitored | 6 mnth |
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| Measure | Description | Time Frame |
|---|---|---|
| Function of upper limb | The mobility of the shoulder will be evaluates in all movements | six month |
| Complications | Possible complications after surgery will be recorded |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Sergio G Susmallian, MD | Assuta Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Medican Center | Tel Aviv | 69710 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34800988 | Derived | Klein I, Kalichman L, Chen N, Susmallian S. A comprehensive approach to risk factors for upper arm morbidities following breast cancer treatment: a prospective study. BMC Cancer. 2021 Nov 20;21(1):1251. doi: 10.1186/s12885-021-08891-5. |
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The patient will be evaluated after discharge by meetings or though video calls/
February 01 2019
Physiotherapy after breast cancer surgery
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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RCT intervention and not intervention
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Participants were blinded to physical support or not
| six month |
| Lymph edema | Radius of upper limb will be measured | 6 mnth |
| physical activities influence in recovery after breast cancer surgery | patient will be agruped by intensity and frequency of PA | 6 mnth |
| D017437 |
| Skin and Connective Tissue Diseases |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |