Effects of Physical Exercise and Motor Activity on Sleep Disorders in Post-Mastectomy Pain Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
Study Overview
Brief 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 sleep disturbance 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, sleep disorders 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 sleep disorders, caused by post-mastectomy chronic pain. of life of women underwent mastectomy
Detailed Description
Chronicization of pain is frequently occurring after surgery, thus leading often 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, was later proposed as "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)".
Chronic pain following mastectomy, referred to at that time as intercostobrachial nerve entrapment syndrome, was first identified in a case series of patients who underwent mastectomy in the 1970s. This condition is now referred to as post-mastectomy pain syndrome (PMPS). The International Association for the Study of Pain (IASP) defines PMPS as persistent, neuropathic pain that develops soon after mastectomy or lumpectomy located in the anterior surface of the chest axilla, shoulder, or upper half of the arm.
The etiology of persistent pain after mastectomy is still unclear, because of its possible multifactoriality with a partial neuropathic origin. While surgical factors, including axillary lymph node dissection, and reconstruction, have been postulated to serve as important risk factors for chronic pain, many studies do not fully support this association. Adjuvant treatment, such as radiation, chemotherapy, and hormone therapy, has also been occasionally associated with persistent pain consequent to mastectomy.
Psychosocial factors such as anxiety, catastrophizing and sleep disorders are being revealed as crucial contributors to individual differences in pain processing and outcomes. There is substantial evidence supporting the association between chronic pain and sleep, as constant pain affects wakefulness and, consequently, sleep quality. Hence, there is a close relationship between chronic pain and insomnia, and sustained sleep restriction further diminishes emotional and physical well-being, leading to depression, chronic fatigue and anxiety in many patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women aging over 18 years with a prior diagnosis of Phase II or III breast cancer who had undergone mastectomy for cancer removal 3 months earlier. -
Exclusion Criteria
- •medical history of other types of cancer;
- •disease related to the immune system (e.g. multiple sclerosis, HIV, lupus);
- •recent symptoms of illness (cough, fever);
- •no antinflammatory or antidepressive or anxiolitic drugs assumption during the first six months after surgery
- •waiting breast reconstruction;
- •not chemotherapy or radiation during the first six months after surgery
Outcomes
Primary Outcomes
Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
Time Frame: Evaluation performed three and six months after surgery
Pain intensity self-measured using the Numerical Rating Scale (NRS). NRS is a 0-11 point-scale where the end points are the extremes of no pain (point 0) and worst pain as bad as it could be (point 10)
Effects of motor and/or sports activity on sleep disorders in women underwent mastectomy suffering by chronic pain.
Time Frame: Evaluation performed three and six months after surgery
Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the quality of sleep. The PSQI is a self-report inventory assessing sleep duration, latency, and overall sleep quality over 1 month time interval. Each item is weighted on a 0-3 interval scale. A score of 0 indicates no difficulty, while a score of 3, indicates severe difficulty. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores indicate an healthier sleep quality. A score ≤ 5 generally reflects a good sleep quality while a score \> 5 reflects a bad sleep qualityInsomnia Severity Index (ISI) The ISI is a self-rated instrument with seven items that assess insomnia's nature, severity, and impact, rated on a 5-point \[0 (no problem) - 4 (very severe problem)\]. Insomnia is graded as absent (score 0-7), mild (score 8-14), moderate (score15-21), and severe (score 22-28)
Secondary Outcomes
- Evaluation of biomarker associated to pain intensity and sleep disorders(Evaluation performed three and six months after surgery])
- Evaluation of serum cortisol(Evaluation performed three and six months after surgery)
Investigators
Gioacchino Calapai
Professor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"