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

NCT05452499 | Completed

• 1 other identifier: Folio No.03-2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Breast neoplasms; Breast cancer survivors; Chronic pain; Pain; Kinesiophobia; Pain neuroscience education; Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in 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

  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

  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 (4)

• Personal characteristics

  This data will be recollected only before the intervention (T0).

• Evaluation of neuropathic and nociceptive type of 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.

• Central sensitization

  Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Pain neuroscience education and therapeutic exercise

Interventions

Pain neuroscience education and therapeutic exercise 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).

Intervention group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Due to the current health situation in a state of pandemic by COVID-19, the patient must have their full COVID-19 vaccination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autónoma de Yucatán: lead

Study Sites (1)

Jose Antonio Lores Peniche

Mérida, Yucatán, 97000, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Kinesiophobia; Pain; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jose Antonio Lores, PT

  Universidad Autónoma de Yucatán

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: September 5, 2022
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

ME (1)