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Clinical Trials/NCT05452499
NCT05452499
Completed
Not Applicable

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

Universidad Autónoma de Yucatán1 site in 1 country26 target enrollmentSeptember 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Universidad Autónoma de Yucatán
Enrollment
26
Locations
1
Primary Endpoint
Changes in pain intensity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2022
End Date
January 9, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Antonio Lores Peniche

Principal Investigator

Universidad Autónoma de Yucatán

Eligibility Criteria

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.
  • 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.

Outcomes

Primary Outcomes

Changes in pain intensity

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

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.

Changes in pain frequency

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

Participants will report the number of days per week with pain.

Secondary Outcomes

  • 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.)

Study Sites (1)

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