Clinical trial NCT04877860: Pain Treatment in a Breast Cancer Population. PaiNEd Study.
Official title: Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: E-health
exercise
telehealth
telerehabilitation
pain management
cancer
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
Secondary outcomes:
measure: Changes from baseline in Pain Catastrophizing Scale at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Central Sensitization Inventory (CSI) at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Kinesiophobia on the Tampa Scale for Kinesiophobia (TSK-11) at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Active shoulder and cervical spine on goniometry at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Functional capacity on the The Six-Minute Walk Test at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Isometric handgrip strength on Hand-held Dynamometry at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Strength endurance deep cervical musculature on cranio-cervical flexion test at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in Body composition by using electrical bioimpedance analysis at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
measure: Changes from baseline in stress and inflammatory responses at 2 and 6 months.
timeFrame: Baseline, 2 and 6 months.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Health Sciences Faculty, University of Granada
Study officials:
affiliation: Health Sciences Faculty, University of Granada
name: Carolina Fernández Lao, PhD
role: STUDY_DIRECTOR
References: