Clinical trial NCT06052085: Investigation of the Efficiency of Pain Neuroscience Education in Patients With Chronic Pain After Breast Cancer Surgery
Official title: Investigation of the Efficiency of Pain Neuroscience Education in Patients With Chronic Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Cronic pain
Side effect
Pain neuroscience education
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most common type of cancer among women worldwide. Various side effects are seen after the treatments (surgery, chemotherapy, radiotherapy, etc.). Fatigue and pain are the most common and persistent side effects of breast cancer treatments. Pain management in patients currently undergoing breast cancer surgery: It consists of medical treatment, physiotherapy program and psychosocial practices. Psychosocial practices include educational interventions. The most widely used is Biomedical Education. Biomedical Education explains pain to the patient from a biological point of view and may be insufficient in curing and preventing chronic pain. The increase in the knowledge of pain physiology has revealed the modern neuroscience-based Pain Neuroscience Education. Pain Neuroscience Education explains the neurophysiology of pain and the ability of the nervous system to modulate the experience of pain. When we look at the literature, it has been seen that the lack of studies in which my Pain Neuroscience Education was applied in chronic pain after breast cancer surgery and the results of existing studies were contradictory. The aim of this study to compare the effects of Pain Neuroscience Education applied together with a standard physiotherapy program on pain, somatode function, psychological function and quality of life in patients with chronic pain after breast cancer surgery in a randomized desing. The hypotheses of this study are as follows; H1(1): The effect of Pain Neuroscience Education and Biomedical Education applied in addition to standard physiotherapy on pain-related outcomes (pain severity and disability) is different in patients with chronic pain after breast cancer surgery.

H1(2): The effect of Pain Neuroscience Education and Biomedical Education applied in addition to standard physiotherapy on somatosensory function (pressure pain threshold and mechanical perception threshold) is different in patients with chronic pain after breast cancer surgery. H1(3) : The effect of Pain Neuroscience Education and Biomedical Education applied in addition to standard physiotherapy on psychological state (psychological symptoms (stress, anxiety and depression), pain-related catastrophe) in patients with chronic pain after breast cancer surgery is different. H1(4) : Pain Neuroscience Education and Biomedical Education applied in addition to standard physiotherapy have different effects on quality of life in patients with chronic pain after breast cancer surgery. The patients were over the age of 18, diagnosed with breast cancer, had at least three months after primary cancer treatments (surgery, chemotherapy, radiotherapy), had pain in the upper extremity and shoulder region for more than three months, and were evaluated on the Visual Analogue Scale in terms of pain intensity in the last week. Patients who indicate at least 40 points out of 100 (VAS) will be included. The Mini Mental Test will be applied to individuals over 65 years of age in terms of cooperation suitability and those with a score of 24 and above will be included in the study. Cases who met the inclusion criteria and accepted to participate in the study will be randomly assigned to 2 separate groups according to the online computer-based block randomization list. Pain Neuroscience Education and standard physiotherapy program (soft tissue mobilization + exercise) will be applied to the individuals in the 1st group, and Biomedical Education and standard physiotherapy program (soft tissue mobilization + exercise) will be applied to the individuals in the 2nd group. The working period is 6 weeks. Individuals in the 1st group will receive 4 sessions of Pain Neuroscience Training, and 4 sessions of Biomedical Pain Training will be applied to the individuals in the 2nd group. Standard physiotherapy will be applied to the cases in both groups for 6 weeks, 2 sessions per week. In the first session of the treatment, individuals in both groups will be informed about the treatment process. Individuals will be evaluated in terms of research and outcome measurements twice, at the beginning of the study and at the end of the 6th week, in line with the control frequencies used routinely in the clinic. The assessment will take approximately 45 minutes for each individual. At the beginning of the study, demographic and physical characteristics of individuals, medical and surgical background (cancer history, treatments, number of sessions and/or cures), drugs used (type and dosage), and lifestyle characteristics (alcohol and smoking and regular physical activity/exercise habits) ) related information will be saved. In the evaluation; Visual Analogue Scale, Pain Disability Index, Digital Pressure Algometer, Semmes Weinstein Monoflames, Pain Disaster Scale, Depression, Anxiety-Stress Scale-21(DASS-21), Functional Assessment of Cancer Treatment-Breast ( FACT-B+4) scale will be used.


Eligibility criteria: Inclusion Criteria:

* Women over 18 years old
* Women diagnosed with breast cancer
* Patients who have passed at least 3 months after their primary treatment such as surgery, radiotherapy, chemotherapy
* Women who have pain in the upper extremity and shoulder region for more than three months and have achieved at least 40 points out of 100 on the Visual Analogue Scale (VAS) in the last week

Exclusion Criteria:

* Patients with chronic pain in the upper extremity/shoulder before the diagnosis of breast cancer,
* Patients who have previously undergone a pain education program,
* Those with metastases, bilateral or recurrent breast cancer,
* Lack of cooperation in assessment and/or treatment and illiteracy,
* Patients who did not consent to the study and did not have an informed consent form

Primary outcomes:
measure: Pain intensity of the upper extremity
timeFrame: Change in pain intensity from baseline up to the end of the 6th week
measure: Pain Related Dysfunction
timeFrame: Change in pain-related dysfunction from baseline to end of week 6
Secondary outcomes:
measure: Somatosensory function: Pressure Pain Threshold
timeFrame: Change in pressure pain threshold from baseline to end of 6 weeks
measure: Somatosensory function: Mechanical Detection Threshold
timeFrame: Change in mechanical detection threshold from baseline up to the end of the 6th week
measure: Psychological Function: Pain Related Catastrophization
timeFrame: Change in Pain Related Catastrophization from baseline to end of week 6
measure: Psychological Function:Psychological Symptoms
timeFrame: Change in psychological symptoms from baseline to end of week 6
measure: Life Quality
timeFrame: Change in life quality from baseline to end of week 6
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Rumeysa Konokman
Study officials:
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