Clinical trial · Interventional
Pain Treatment in a Breast Cancer Population. PaiNEd Study.
Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.
- 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)
The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.
Conditions
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Other | — | UNRESOLVED |
| Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) | Other | — | UNRESOLVED |
| Multimodal rehabilitation program + traditional biomedical information | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)
- description
- Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system.
- interventionNames
- Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)
- type
- ACTIVE_COMPARATOR
- label
- Multimodal rehabilitation program + traditional biomedical information
- description
- Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Dossier with traditional biomedical recommendations on the management of pain and disability.
- interventionNames
- Other: Multimodal rehabilitation program + traditional biomedical information
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects over 18 years of age. 2. Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago. 3. Not having active cancer. 4. Having pain in the regions related to the tumor area (cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for\> 4 weeks 5. Present musculoskeletal or functional alterations in the previous regions. Exclusion Criteria: 1. Identification by the research team of physical or mental impossibility to carry out the tests of the study. 2. Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.
References
Publications (1)
- DERIVEDFernandez-Gualda MA, Ariza-Vega P, Lozano-Lozano M, Cantarero-Villanueva I, Martin-Martin L, Castro-Martin E, Arroyo-Morales M, Tovar-Martin I, Lopez-Garzon M, Postigo-Martin P, Gonzalez-Santos A, Artacho-Cordon F, Ortiz-Comino L, Galiano-Castillo N, Fernandez-Lao C. Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol. PLoS One. 2023 Aug 15;18(8):e0290096. doi: 10.1371/journal.pone.0290096. eCollection 2023. PMID 37582097