Pain Treatment in a Breast Cancer Population. PaiNEd Study.

University of Granada (UGR)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE); Other: Multimodal rehabilitation program + traditional biomedical information; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04877860

PI-0171-2020

Details and patient eligibility

About

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.

Full description

People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. 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. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. 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 the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

Experimental group

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.

Treatment:

Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

Multimodal rehabilitation program + traditional biomedical information

Active Comparator group

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.

Treatment:

Other: Multimodal rehabilitation program + traditional biomedical information

Control group

Active Comparator group

Description:

Information dossier with recommendations on pain control and dysfunction improvement.

Treatment:

Other: Control group