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

NCT ID: NCT05452499

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2023-01-09

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.

Conditions

Breast Neoplasms; Pain, Chronic; Kinesiophobia; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Pain neuroscience education and therapeutic exercise

Intervention Type: OTHER

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).

Interventions

Pain neuroscience education and therapeutic exercise

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autónoma de Yucatán

OTHER

Sponsor Role: lead

Responsible Party

José Antonio Lores Peniche

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Antonio Lores, PT

Role: PRINCIPAL_INVESTIGATOR

Universidad Autónoma de Yucatán

Locations

Jose Antonio Lores Peniche

Mérida, Yucatán, Mexico

Countries

Mexico

Other Identifiers

Folio No.03-2022

Identifier Type: -

Identifier Source: org_study_id