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临床试验/NCT05452499
NCT05452499已完成不适用

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 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Changes in pain intensity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Intervention group

Experimental

干预措施: Pain neuroscience education and therapeutic exercise (Other)

结局指标

主要结局

Changes in pain intensity

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Antonio Lores Peniche

Principal Investigator

Universidad Autónoma de Yucatán

研究点 (1)

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