Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors
Unknown statusNot applicableNCT04965909
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Introduction: Pain stands out among the sequelae that affect the quality of life of breast cancer survivors. Pain neuroscience education and graded exposure to movement are therapeutic approaches that have been shown to be effective in the management of chronic pain in other populations. However, there are no previous studies that combine them in this population. Objective: To evaluate the effectiveness of an online physiotherapy focused-person program which combines pain neuroscience education and graded exposure to movement, to improve the quality of life of breast cancer survivors. Methodology: The design of the study is a randomised controlled clinical trial and the sample will be 40 breast cancer survivors with pain in the last 6 months. A random method will be used to assign participants into two groups (experimental and control). The evaluator and statistician will be blinded to participant allocation while the experimental group will receive the therapeutic program which combines pain neuroscience education and graded exposure to movement-based intervention throughout therapeutic yoga; the control will be a passive group. There will be four points of assessment: the main outcome assessed will be quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the secondary outcomes are variables related to pain experience (catastrophising, self-efficacy, kinesiophobia and fear-avoidance behaviours). All will be assessed using validated methods. SPSS program will be used for the data analysis. A mixed-model analyses of variance ANOVA (2x4) will be used to study the effects of the treatment on the dependent variables. An intention-to-treat analysis will be performed. All statistical tests will be performed considering a confidence interval of 95%. Trial record: NCT04965909.
Study details
- Official title
- Online Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors: Protocol of a Randomised Controlled Trial.
- Interventions
- Other: Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement.
- Sponsor
- University of Seville
- Start date
- 2021-04-01
- Primary completion
- 2024-12-01
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria: * Woman aged between 18 - 65 years. * Diagnosis of stage 0 - III breast cancer. * Primary treatment (surgery, radiotherapy and chemotherapy) completed at least 3 months ago may still be receiving hormonal therapy. * Pain related to primary treatment in the last 6 months. * Access to Internet and an electronic device that allows the use of the applications used in this study and skills for their use or assistance from a close person who has them. * Ability to communicate fluently verbally and in writing in the language of the research team (Spanish). * Approval of participation in the study by the coordinator of the health team that assisted her during the course of cancer and its treatment. Exclusion criteria: * Another previous type of cancer or breast cancer recurrence in a period of less than 1 year. * Medical diagnosis of a neurological, autoimmune or cardiovascular disease. * Some type of pathology that is associated with a contraindication to physical exercise. * Diagnosis of serious psychiatric or neurologic disorders that do not allow the participant to follow orders.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04965909