Physical Exercise, Motor Activity and Depression in Post-mastectomy Pain Syndrome
Condition: Chronic Pain
MeSH terms: Chronic Pain; Depression
Study type: Observational

Summary: 
      Pain is an unpleasant sensation common to all those who undergo surgery. Several studies
      indicate that 40-60% of patients experience the post-operative experience and can be caused
      by both internal and external stimuli. Chronic post mastectomy pain is a condition
      characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to
      surgery, which begins after mastectomy or quadrantectomy and persists for longer three months
      after surgery. It can become chronic in a broad spectrum of conditions. Psychosocial factors
      such as anxiety and catastrophizing are being revealed as crucial contributors to individual
      differences in pain processing and outcomes. Some researchers have reported the associations
      between the development of persistent pain catastrophizing and depression or psychological
      distress and reduced physical activity. Taken together, these symptoms may lead to disability
      and worsened quality of life. Due to its benefits, the American Cancer Society recommends to
      begin as soon as possible from the diagnosis of cancer, physical activity. Aim of this
      prospective observational study is to evaluate the effects of motor and/or sports activity on
      the intensity of chronic pain and in symptoms of depression and anxiety, caused by
      post-mastectomy chronic pain. of life of women underwent mastectomy.
    

Detailed description: 
      Chronic pain is one of the most frequent occurring after surgery. It leads to functional
      limitations and psychological disorders, with a negative impact on quality of life.

      Chronic post-surgical pain (CPSP) was first defined as "pain that develops after surgical
      intervention and lasts at least 2 months; other causes of pain have to be excluded, in
      particular, pain from a condition existing before the surgery".

      An updated definition of CPSP, or persistent post-surgical pain (PPSP), was later proposed by
      Werner and Kongsgaard in 2014. The proposed definition was "pain persisting at least three
      months after surgery, that was not present before surgery, or that had different
      characteristics or increased intensity from preoperative pain, localized to the surgical site
      or a referred area, and other possible causes of the pain were excluded (e.g., cancer
      recurrence, infection)".

      Persistent post-mastectomy pain (PPMP) is a major individual and public health problem. The
      etiology of persistent pain after mastectomy is still unclear, although it is likely
      multifactorial and may be partially of neuropathic origin. While surgical factors, including
      more extensive surgery (total vs partial mastectomy), axillary lymph node dissection, and
      reconstruction, have been postulated to serve as important risk factors for chronic pain,
      many studies do not support this association. Adjuvant treatment, such as radiation,
      chemotherapy, and hormone therapy, has also been occasionally associated with persistent
      pain.It is estimated that 25-60% of patients who have undergone breast cancer removal surgery
      suffer from PMP syndrome and psychosocial factors such as anxiety, depression, sleep
      disturbance and catastrophizing have proven to be important contributors to the development
      of persistent pain . A link between pain and depression is well known, it is suggested that
      30%-45% of patients affected by chronic pain, experience depression. Several studies have
      suggested a bidirectional relationship between depression and pain, suggesting that
      depression is a positive predictor of the development of chronic pain and chronic pain can
      increases the risk of developing depression. Moreover depression is considered a moderator of
      the relationship between pain severity and physical functioning . It is known that depressive
      disorders overlap with anxiety disorders, anxiety symptoms are included in the diagnostic
      criteria for major depressive disorder in the diagnostic and statistical manual of mental
      disorders 5th edition (DSM-5). Results obtained from from case control studies suggest that
      inflammation could be involved in generalized anxiety disorder, indicating that inflammation
      could increase subsequent to the development of an anxiety disorder.

      The aim of this study was to evaluate the effects of physical activity on the intensity and
      interference of chronic pain in daily activities and the effect on depression and anxiety in
      patient underwent mastectomy.

      Study population: women underwent unilateral or bilateral mastectomy due to resection of
      stage II and III breast cancer not followed by breast reconstruction aged 18 years or older
      who have not received chemotherapy or radiation. Pain assessment: Pain assessment is a
      multidimensional process, which must take into account all the components of suffering, both
      physically, psychologically and socially. The assessment of pain and motor activity of each
      participant in the study will be carried out 3 and 6 months after surgery. Pain will be
      assessed by administration of Numerical Rating Scale (NRS) questionnaire. For the evaluation
      of depression, was used the Beck's Depression Inventory (BDI) and for the anxiety evaluation,
      will be administered the Generalized Anxiety Disorders-7 (GAD-7). All the evaluation will be
      performed 3 and 6 months after surgery.

      The IPAQ (International Physical Activity Questionnaire) questionnaire measures the type and
      amount of physical activity that is normally done. The questions refer to the activity
      carried out in the last 7 days. It will be administered at 3 and 6 months after surgery.The
      expected duration of the study can be considered to be approximately 12 months. At the same
      time-points (12 and 24 weeks after surgery) biomarkers of pain, inflammation and correlated
      to anxiety and depression will be measured together with routine blood parameters.
      Specifically, the following biomarkers will be evaluated: IL-17, IL-1beta, brain-derived
      neutrophic factor (BDNF), cortisol and adrenocorticotropic hormone (ACTH).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women underwent unilateral or bilateral mastectomy due to resection of stage II and III
        breast cancer.
      
Biospecimen description: 
      serum
    
Keywords: Chronic pain; post mastectomy; depression; anxiety; motor activity; haematological markers