Investigation of the Efficiency of Pain Neuroscience Education in Patients With Chronic Pain After Breast Cancer Surgery

NCT06052085 | Unknown

• 1 other identifier: KA-22059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Cronic pain; Side effect; Pain neuroscience education

Outcome Measures

Primary Outcomes (2)

• Pain intensity of the upper extremity

  In our study, Visual Analog Scale(VAS) will be used to measure subjectively perceived pain. The Visual Analogue Scale (VAS) is a horizontal line of 0-10 cm denoting the absence of pain at one end and the most severe pain possible at the other. The subjects will be asked to mark the pain they have experienced in the last 3 days on the VAS.

  Change in pain intensity from baseline up to the end of the 6th week

• Pain Related Dysfunction

  Pain Disability Questionnaire (PDQ) will be used to measure pain-related disability. The Pain Disability Questionnaire (PDQ) is a seven-item scale aiming to determine the functional losses related to the musculoskeletal system suffered by the patient due to pain. From the patient, by giving 0 to 10 points to all questions; are asked to rate the impact on daily living activities, including family-home responsibilities, leisure activities, occupation, social activities, sexuality, and self-care. The total score ranges from 0 to 70. If the result is over 40 points, it means high disability.

  Change in pain-related dysfunction from baseline to end of week 6

Secondary Outcomes (5)

• Somatosensory function: Pressure Pain Threshold

  Change in pressure pain threshold from baseline to end of 6 weeks

• Somatosensory function: Mechanical Detection Threshold

  Change in mechanical detection threshold from baseline up to the end of the 6th week

• Psychological Function: Pain Related Catastrophization

  Change in Pain Related Catastrophization from baseline to end of week 6

• Psychological Function:Psychological Symptoms

  Change in psychological symptoms from baseline to end of week 6

• Life Quality

  Change in life quality from baseline to end of week 6

Study Arms (2)

Pain Neuroscience Education

ACTIVE COMPARATOR

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.

Other: Pain Neuroscience Education; Other: Standard Physiotherapy Program

Biomedical Pain Education

ACTIVE COMPARATOR

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.

Other: Biomedical Pain Education; Other: Standard Physiotherapy Program

Interventions

Pain Neuroscience Education OTHER

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.

Pain Neuroscience Education

Biomedical Pain Education OTHER

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.

Biomedical Pain Education

Standard Physiotherapy Program OTHER

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; Pain Neuroscience Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Rumeysa Konokman

Ankara, 06690, Turkey (Türkiye)

RECRUITING

Related Publications (9)

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  PMID: 31284377 BACKGROUND

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  PMID: 21999358 BACKGROUND

• 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.

  PMID: 33677717 BACKGROUND

• 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.

  PMID: 11124730 BACKGROUND

• 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.

  PMID: 6240632 BACKGROUND

• 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.

  PMID: 20011713 BACKGROUND

• 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.

  PMID: 26826097 BACKGROUND

• 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.

  PMID: 25558568 BACKGROUND

• 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.

  PMID: 29900947 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ceren Gürşen, PhD

CONTACT

+905380644120; cerengursen@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doc. Dr.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: February 15, 2023
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)