Pain Treatment in a Breast Cancer Population. PaiNEd Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental design with two intervention groups and a control group. Effectiveness study.

Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants who meet the inclusion criteria will be randomized into each of the groups using a random number generation program (EPIDAT 4.2, junta de Galicia). The sequence will be placed in an opaque envelope closed by a member outside the investigation and will be opened once the baseline assessment is completed, so the assessment staff will be masked for the randomization of the participants, thus reducing the risk of bias during the evaluation. The blinding of evaluators will be guaranteed by the fact that some members of the group are specialized in the treatment of cancer patients and others in their evaluation.

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Multimodal rehabilitation program + traditional biomedical information

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.

Group Type ACTIVE_COMPARATOR

Multimodal rehabilitation program + traditional biomedical information

Intervention Type OTHER

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.

Control group

Information dossier with recommendations on pain control and dysfunction improvement.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No