Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae

Study Overview
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Brief Summary
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Introduction: Breast cancer represents the most common type of malignant neoplasm worldwide. Advances in diagnosis and treatment have increased the life expectancy of patients. However, the sequelae associated with treatment and disease in survivors such as chronic pain, kinesiophobia and loss of physical function represent a long-term health problem. Physical therapy is a frequently used strategy for the treatment of sequelae in the acute stage of the disease, but there is a need to evaluate its effectiveness in cancer survivors with chronic sequelae. Therapeutic exercise and pain neuroscience education have been shown to be effective in the management of populations with chronic pain and loss of function; however, more evidence is needed in specific populations of cancer survivors. Objective:To evaluate the effectiveness of a physical therapy program based on pain neuroscience education and therapeutic exercise for the treatment of chronic pain, kinesiophobia and loss of physical function in breast cancer survivors. Methodology. Quasi-experimental study. The sample will consist of 40 female breast cancer survivors. The intervention will last 9 weeks, with 3 sessions of pain neuroscience education and 24 sessions of therapeutic exercise, 3 times per week (16 face-to-face sessions and 8 sessions at home). The intervention will be carried out in small groups of 8 to 12 people. The frequency and intensity of pain, the level of kinesiophobia and physical functionality and the range of of motion of the shoulder will be evaluated in 4 assessments, before the intervention (T0), 3rd (T1), 6th (T2) and 9th (T3) week of the intervention. Different validated measurement instruments will be used in this population such as self-report scales, questionnaires and the use of a goniometer.

Official Title
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Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Chronic Pain, Kinesiophobia and Increased Physical Functionality in Breast Cancer Survivors

Conditions
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Breast Neoplasms, Pain, Chronic, Kinesiophobia, Breast Cancer

Intervention / Treatment
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* Other: Pain neuroscience education and therapeutic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had a stage I to III diagnosis. Report a pain intensity of 30 millimeters or more in the Visual Analoge Scale (VAS). Be in completed remission and have completed primary treatment at least three months age. Adjuvant hormone therapy or inmunotherapy is accepted. Present pain in the neck, arms or shoulder of the affected side after primary cancer treatment, and that is repeated or maintained for a period longer than three months. Presenting kinesiophobia measured with the Tampa Scale for Kinesiophobia (TSK-11V). That presents alterations in the physical functionality of the upper limb, measured with the Upper Limb Functional Index (ULFI-Sp). Who is willing to participate through informed consent. 9. Due to the current health situation in a state of pandemic by COVID-19, the patient must have their full COVID-19 vaccination. Exclusion Criteria: That presents some other type of cancer or metastasis at the time of the study. Have uncontrolled lymphedema or uncontrolled hypertension. That presents a musculoskeletal pathology in the upper limb or a chronic health condition that limits the performance of the therapeutic exercise. Difficulty understanding the Spanish language that limits the comprehension of the evaluation instruments or participating in the pain neuroscience education program.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: Pain neuroscience education and therapeutic exercise<br>* Participants will receive a 9-week physiotherapy program. Consisting of 3 sessions of pain neuroscience education and 24 sessions of therapeutic exercise (16 face-to-face sessions and 8 at home).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain intensity | Pain intensity will be measured using the visual analog scale (VAS), participants will report their pain intensity within a range of 0 to 100 millimeters, with 0 being no pain and 100 being the maximum pain. | Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program. | 
| Changes in pain frequency | Participants will report the number of days per week with pain. | Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in kinesiophobia | Kinesiophobia will be measured through the Tampa Kinesiophobia Scale Spanish version with 11 items (TSK-11V). It consists of a self-report instrument with 11 items related to fear of movement or injury relapse. Each ítem is measured on a Likert-type scale between 1 and 4 points, being 1 totally disagree and 4 totally agree, being able to obtain a total between a range of 11 to 44 final points. The higher the score, the higher the level of kinesiophobia. | Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program. | 
| Changes in physical functionality | Physical functionality will be measured through the Upper Limb Functional Index scale (ULFI-Sp), which consists of a list of 25 items. Each item is scored on a 3-point scale by filling in a box, so that filling in the whole box means strongly agree, half a box means partially agree, and leaving it empty means strongly disagree, giving it a score of 1, 0.5 and 0 points respectively. The total score (25 points maximum) is multiplied by 4 to obtain a score based on 100 points, of which 0 would represent no functional limitation and 100 maximum limitation. The first 16 items refer to common functional activities, while the other 9 focus on activities involving the use of the upper limb. | Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program. | 
| Shoulder range of motion | Active joint range of motion (active ROM) will be measured as part of the physical function assessment of the patient's upper limb. Flexion, horizontal flexion, extension, internal rotation, external rotation and abduction of both shoulders will be measured. Active ROM will be measured using a BASELINE® brand 12-inch shoulder goniometer. Three goniometric measurements will be taken per movement, and the average will be taken to obtain a value of the active ROM between a range of 0 and 180 degrees. | Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast neoplasms, Breast cancer survivors, Chronic pain, Pain, Kinesiophobia, Pain neuroscience education, Exercise