Pain Treatment in a Breast Cancer Population. PaiNEd Study.

Summary

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

• Breast Cancer

Interventions

OTHER

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

The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement.

OTHER

Multimodal rehabilitation program + traditional biomedical information

The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment.

OTHER

Control group

Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.

Sponsors & Collaborators

• Universidad de Granada

  lead OTHER

Principal Investigators

• Carolina Fernández Lao, PhD · Health Sciences Faculty, University of Granada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2024-01-31

Completion

2024-04-30

Countries

• Spain

Study Locations