Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06052085
Study type Interventional
Source Hacettepe University
Contact Ceren Gürsen, PhD
Phone +905380644120
Email cerengursen@yahoo.com
Status Recruiting
Phase N/A
Start date February 15, 2023
Completion date February 15, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A