search
Back to results

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

Primary Purpose

Breast Neoplasms, Pain, Chronic, Kinesiophobia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Pain neuroscience education and therapeutic exercise
Sponsored by
Universidad Autónoma de Yucatán
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast neoplasms, Breast cancer survivors, Chronic pain, Pain, Kinesiophobia, Pain neuroscience education, Exercise

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jose Antonio Lores Peniche

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in kinesiophobia
Kinesiophobia will be measured through the Tampa Kinesiophobia Scale Spanish version with 11 items (TSK-11V). It consists of a self-report instrument with 11 items related to fear of movement or injury relapse. Each ítem is measured on a Likert-type scale between 1 and 4 points, being 1 totally disagree and 4 totally agree, being able to obtain a total between a range of 11 to 44 final points. The higher the score, the higher the level of kinesiophobia.
Changes in physical functionality
Physical functionality will be measured through the Upper Limb Functional Index scale (ULFI-Sp), which consists of a list of 25 items. Each item is scored on a 3-point scale by filling in a box, so that filling in the whole box means strongly agree, half a box means partially agree, and leaving it empty means strongly disagree, giving it a score of 1, 0.5 and 0 points respectively. The total score (25 points maximum) is multiplied by 4 to obtain a score based on 100 points, of which 0 would represent no functional limitation and 100 maximum limitation. The first 16 items refer to common functional activities, while the other 9 focus on activities involving the use of the upper limb.
Shoulder range of motion
Active joint range of motion (active ROM) will be measured as part of the physical function assessment of the patient's upper limb. Flexion, horizontal flexion, extension, internal rotation, external rotation and abduction of both shoulders will be measured. Active ROM will be measured using a BASELINE® brand 12-inch shoulder goniometer. Three goniometric measurements will be taken per movement, and the average will be taken to obtain a value of the active ROM between a range of 0 and 180 degrees.

Full Information

First Posted
July 6, 2022
Last Updated
March 24, 2023
Sponsor
Universidad Autónoma de Yucatán
search

1. Study Identification

Unique Protocol Identification Number
NCT05452499
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autónoma de Yucatán

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Pain, Chronic, Kinesiophobia, Breast Cancer
Keywords
Breast neoplasms, Breast cancer survivors, Chronic pain, Pain, Kinesiophobia, Pain neuroscience education, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education and therapeutic exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in pain intensity
Description
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.
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.
Title
Changes in pain frequency
Description
Participants will report the number of days per week with pain.
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.
Secondary Outcome Measure Information:
Title
Changes in kinesiophobia
Description
Kinesiophobia will be measured through the Tampa Kinesiophobia Scale Spanish version with 11 items (TSK-11V). It consists of a self-report instrument with 11 items related to fear of movement or injury relapse. Each ítem is measured on a Likert-type scale between 1 and 4 points, being 1 totally disagree and 4 totally agree, being able to obtain a total between a range of 11 to 44 final points. The higher the score, the higher the level of kinesiophobia.
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.
Title
Changes in physical functionality
Description
Physical functionality will be measured through the Upper Limb Functional Index scale (ULFI-Sp), which consists of a list of 25 items. Each item is scored on a 3-point scale by filling in a box, so that filling in the whole box means strongly agree, half a box means partially agree, and leaving it empty means strongly disagree, giving it a score of 1, 0.5 and 0 points respectively. The total score (25 points maximum) is multiplied by 4 to obtain a score based on 100 points, of which 0 would represent no functional limitation and 100 maximum limitation. The first 16 items refer to common functional activities, while the other 9 focus on activities involving the use of the upper limb.
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.
Title
Shoulder range of motion
Description
Active joint range of motion (active ROM) will be measured as part of the physical function assessment of the patient's upper limb. Flexion, horizontal flexion, extension, internal rotation, external rotation and abduction of both shoulders will be measured. Active ROM will be measured using a BASELINE® brand 12-inch shoulder goniometer. Three goniometric measurements will be taken per movement, and the average will be taken to obtain a value of the active ROM between a range of 0 and 180 degrees.
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.
Other Pre-specified Outcome Measures:
Title
Personal characteristics
Description
An initial survey with 2 sections will be applied: the first will collect information on sociodemographic variables such as: age, marital status, occupation, level of schooling, weight, height, BMI, habits (alcohol and tobacco) and comorbidities. The second will contain questions on the clinical characteristics of breast cancer such as: number of months with pain, time since initial diagnosis, time elapsed and stage of breast cancer at diagnosis, type of breast cancer according to histological classification, hormone receptor status, location of breast cancer (right, left or bilateral), type of surgery and other treatments (radiotherapy, chemotherapy, hormone therapy or inmunotherapy), the region of pain (axilla, shoulder, arm or thorax).
Time Frame
This data will be recollected only before the intervention (T0).
Title
Evaluation of neuropathic and nociceptive type of pain
Description
The DN4 questionnarie will be used to discriminate between neuropathic and nociceptive type of pain. The DN4 questionnaire consists of a total of 10 items grouped in 4 sections. The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other 3 items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as the sum of all 10 items, and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
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.
Title
Central sensitization
Description
To evaluate central sensitization related symptoms part A of the Spanish Central Sensitization Inventory (CSI) will be used. Part A of the CSI assesses 25 health-related symptoms common to central sensitization, with total scores ranging from 0 to 100. . A total score of 40 or higher indicates the presence of central sensitization.
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.
Title
Evaluation of nociplastic type of pain.
Description
To evaluate possible nociplastic pain, the clinical criteria for nociplastic pain affecting the musculoeskeletal system propose by the International Association for The Study of Pain (IASP) Terminology Task Force (TTF) will be used. It consists of 4 items to clinically evaluate: the type of pain (if greater than 3 months, its distribution and the presence or not of nociceptive type of pain), history of hypersensitivity in the region of pain, presence of comorbidities (sensitivity to sound or light, sleep problems, fatigue or cognitive problems), evoked pain hypersensitivity in the region of pain (static mechanical allodynia, static dynamic allodynia, allodynia to heat or cold). Presence of item 1 and 4 is classifed as possible nociplastic pain, and all of the above (item 1, 2, 3 and 4) as probable nociplastic pain.
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Antonio Lores, PT
Organizational Affiliation
Universidad Autónoma de Yucatán
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Antonio Lores Peniche
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs