Clinical trial NCT05452499: Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
Official title: Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Chronic Pain, Kinesiophobia and Increased Physical Functionality in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Pain, Chronic
Kinesiophobia
Breast Cancer
Keywords: Breast neoplasms
Breast cancer survivors
Chronic pain
Pain
Kinesiophobia
Pain neuroscience education
Exercise
Lead sponsor: Universidad Autónoma de Yucatán
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 26
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Have had a stage I to III diagnosis.
2. Report a pain intensity of 30 millimeters or more in the Visual Analoge Scale (VAS).
3. Be in completed remission and have completed primary treatment at least three months age. Adjuvant hormone therapy or inmunotherapy is accepted.
4. 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.
5. Presenting kinesiophobia measured with the Tampa Scale for Kinesiophobia (TSK-11V).
6. That presents alterations in the physical functionality of the upper limb, measured with the Upper Limb Functional Index (ULFI-Sp).
7. 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:

1. That presents some other type of cancer or metastasis at the time of the study.
2. Have uncontrolled lymphedema or uncontrolled hypertension.
3. That presents a musculoskeletal pathology in the upper limb or a chronic health condition that limits the performance of the therapeutic exercise.
4. Difficulty understanding the Spanish language that limits the comprehension of the evaluation instruments or participating in the pain neuroscience education program.

Primary outcomes:
measure: Changes in pain intensity
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
measure: Changes in pain frequency
timeFrame: 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 outcomes:
measure: Changes in kinesiophobia
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
measure: Changes in physical functionality
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
measure: Shoulder range of motion
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
Other outcomes:
measure: Personal characteristics
timeFrame: This data will be recollected only before the intervention (T0).
measure: Evaluation of neuropathic and nociceptive type of pain
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
measure: Central sensitization
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
measure: Evaluation of nociplastic type of pain.
timeFrame: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
Locations:
city: Mérida
country: Mexico
facility: Jose Antonio Lores Peniche
state: Yucatán
Study officials:
affiliation: Universidad Autónoma de Yucatán
name: Jose Antonio Lores, PT
role: PRINCIPAL_INVESTIGATOR
References: