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NCT Number: NCT03389204

Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention

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.

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Key information

Conditions

Breast Neoplasms Arthralgia Breast Diseases Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medican Center

Tel Aviv, 69710, Israel

About this study

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

  • Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
  • Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women
  • Age 18-65.
  • Diagnosed with breast cancer, undergoing breast surgery,
  • Functional independence prior to the operation.
  • Ability to communicate in Hebrew.

Exclusion criteria

  • Cognitive disorders, patients unable to sign the consent form.
  • Back and spinal morbidity.
  • Fibromyalgia or chronic pain disorders.
  • Neurological disorders.
  • Renal failure with the need for dialysis.
  • Lymphedema prior to surgery.
  • History of breast surgery.
  • Shoulder surgery or shoulder injuries with limited ROM.
  • Ischemic heart disease, heart failure and radical heart insufficiency.
  • Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.

Treatment and study plan

Physical Therapy

Other

EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT

Primary outcomes

  1. Shoulder pain

    Time frame: 6 mnth

    The intensity of pain and chronological modification will be monitored

Other outcomes

  1. Function of upper limb

    Time frame: six month

    The mobility of the shoulder will be evaluates in all movements

  2. Complications

    Time frame: six month

    Possible complications after surgery will be recorded

  3. Lymph edema

    Time frame: 6 mnth

    Radius of upper limb will be measured

  4. physical activities influence in recovery after breast cancer surgery

    Time frame: 6 mnth

    patient will be agruped by intensity and frequency of PA

Sponsors and collaborators

Lead sponsor

Assuta Medical Center

Other

Registry information

Official study title

Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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