Investigation of the Efficiency of Pain Neuroscience Education in Patients With Chronic Pain After Breast Cancer Surgery
NCT ID: NCT06052085
Last Updated: 2023-09-25
Study Results
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Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-02-15
2025-02-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pain Neuroscience Education
Pain Neuroscience Education; Four sessions of education will be applied. The neurophysiology of pain and the ability of the nervous system to modulate the experience of pain will be explained to the patient.
Standard Physiotherapy Program; Soft tissue mobilization will be applied to the upper extremity twice a week for 6 weeks.
Upper extremity exercises including breathing, warming, stretching and strengthening will be performed twice a week for 6 weeks.
Pain Neuroscience Education
Four sessions of Pain Neuroscience Education will be applied. The neurophysiology of pain and the ability of the nervous system to modulate the experience of pain will be explained to the patient.
Standard Physiotherapy Program
Soft tissue mobilization will be applied to the upper extremity twice a week for 6 weeks. Upper extremity exercises including breathing, warming, stretching and strengthening will be performed twice a week for 6 weeks.
Biomedical Pain Education
Biomedical Pain Education; 4 sessions of education will be applied in 6 weeks. Pain will be explained to the patient from a biological point of view.
Standard Physiotherapy Program; Soft tissue mobilization will be applied to the upper extremity twice a week for 6 weeks.
Upper extremity exercises including breathing, warming, stretching and strengthening will be performed twice a week for 6 weeks.
Biomedical Pain Education
4 sessions of Biomedical Pain Education will be applied in 6 weeks. Pain will be explained to the patient from a biological point of view.
Standard Physiotherapy Program
Soft tissue mobilization will be applied to the upper extremity twice a week for 6 weeks. Upper extremity exercises including breathing, warming, stretching and strengthening will be performed twice a week for 6 weeks.
Interventions
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Pain Neuroscience Education
Four sessions of Pain Neuroscience Education will be applied. The neurophysiology of pain and the ability of the nervous system to modulate the experience of pain will be explained to the patient.
Biomedical Pain Education
4 sessions of Biomedical Pain Education will be applied in 6 weeks. Pain will be explained to the patient from a biological point of view.
Standard Physiotherapy Program
Soft tissue mobilization will be applied to the upper extremity twice a week for 6 weeks. Upper extremity exercises including breathing, warming, stretching and strengthening will be performed twice a week for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Ceren Gursen
Doc. Dr.
Locations
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Rumeysa Konokman
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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De Groef A, Penen F, Dams L, Van der Gucht E, Nijs J, Meeus M. Best-Evidence Rehabilitation for Chronic Pain Part 2: Pain during and after Cancer Treatment. J Clin Med. 2019 Jul 5;8(7):979. doi: 10.3390/jcm8070979.
Ling CC, Lui LY, So WK. Do educational interventions improve cancer patients' quality of life and reduce pain intensity? Quantitative systematic review. J Adv Nurs. 2012 Mar;68(3):511-20. doi: 10.1111/j.1365-2648.2011.05841.x. Epub 2011 Oct 17.
Manfuku M, Nishigami T, Mibu A, Yamashita H, Imai R, Tanaka K, Kitagaki K, Hiroe K, Sumiyoshi K. Effect of perioperative pain neuroscience education in patients with post-mastectomy persistent pain: a retrospective, propensity score-matched study. Support Care Cancer. 2021 Sep;29(9):5351-5359. doi: 10.1007/s00520-021-06103-1. Epub 2021 Mar 6.
Von Korff M, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3140-51. doi: 10.1097/00007632-200012150-00009. No abstract available.
Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
Cathcart S, Winefield AH, Rolan P, Lushington K. Reliability of temporal summation and diffuse noxious inhibitory control. Pain Res Manag. 2009 Nov-Dec;14(6):433-8. doi: 10.1155/2009/523098.
Mucke M, Cuhls H, Radbruch L, Baron R, Maier C, Tolle T, Treede RD, Rolke R. Quantitative sensory testing (QST). English version. Schmerz. 2021 Nov;35(Suppl 3):153-160. doi: 10.1007/s00482-015-0093-2.
Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
Ugurlu M, Ugurlu GK, Erten S, Ulusoy Kaymak S, Caykoylu A. Reliability and Factorial Validity of the Turkish Version of the Pain Disability Index in Rheumatic Patients With Chronic Pain. Arch Rheumatol. 2016 Apr 26;31(3):265-271. doi: 10.5606/ArchRheumatol.2016.5750. eCollection 2016 Sep.
Other Identifiers
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KA-22059
Identifier Type: -
Identifier Source: org_study_id
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