Clinical trial · Interventional
Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors
Online Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors: Protocol of a Randomised Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain, Chronic | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Educational and therapeutic exercise program
- description
- Participants will receive a 3-month online physiotherapy program comprised of 'pain neuroscience education' (month 1) and 'gradual exposure to movement' (month 2 and 3). They will receive an informative booklet online.
- interventionNames
- Other: Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement.
- type
- NO_INTERVENTION
- label
- Passive control group (usual care)
- description
- Participants will receive the 'usual care'. They will receive an informative booklet online and the possibility of receiving the therapeutic program, once the study is completed.
Primary outcomes (1)
- measure
- Change from quality of life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDWatson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1. PMID 30831273
- BACKGROUNDDe 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. PMID 31284377
- BACKGROUNDCramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1(1):CD010802. doi: 10.1002/14651858.CD010802.pub2. PMID 28045199
- BACKGROUNDGatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581. PMID 17592957
- DERIVEDMartinez-Miranda P, Jimenez-Rejano JJ, Munoz-Fernandez MJ, Garcia-Munoz C, Casuso-Holgado MJ. Effectiveness of an interactive online group intervention based on pain neuroscience education and graded exposure to movement in breast cancer survivors with chronic pain: a randomised controlled trial. Support Care Cancer. 2024 Oct 7;32(10):705. doi: 10.1007/s00520-024-08887-4. PMID 39373766
- DERIVEDMartinez-Miranda P, Casuso-Holgado MJ, Garcia-Munoz C, Munoz-Fernandez MJ, Jimenez-Rejano JJ. Online pain neuroscience education and graded exposure to movement in breast cancer survivors: protocol of a randomized controlled trial. Front Med (Lausanne). 2024 Feb 28;11:1355964. doi: 10.3389/fmed.2024.1355964. eCollection 2024. PMID 38482528