Breast NeoplasmsNCT05452499
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
A study testing Pain neuroscience education and therapeutic exercise in people with Breast Neoplasms and Pain, Chronic, run by Universidad Autónoma de Yucatán at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms, Pain, Chronic, Kinesiophobia
- What is being tested?
- Pain neuroscience education and therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteMexico
- Study dates
- 5 Sep 2022to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Chronic Pain, Kinesiophobia and Increased Physical Functionality in Breast Cancer Survivors
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
- Being tested
- Pain neuroscience education and therapeutic exercise
- Keywords
- Breast neoplasms, Breast cancer survivors, Chronic pain, Pain, Kinesiophobia, Pain neuroscience education, Exercise
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Kinesiophobia, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience education and therapeutic exerciseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Pain neuroscience education and therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Four evaluations will be performed, before the intervention (T0) and at the 3rd (T1), 6th (T2) and 9th (T3) week of the physiotherapy program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start5 Sep 2022
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Yucatán
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Antonio Lores Peniche, Universidad Autónoma de Yucatán
- Investigators
- Jose Antonio Lores, PT, Principal investigator, Universidad Autónoma de Yucatán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452499
- Sponsor's protocol ID
- Folio No.03-2022
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lores-Peniche JA, Uicab Pool GLA, Aguinaga-Malanco S. Pain neuroscience education and therapeutic exercise for the treatment of sequelae in breast cancer survivors living with chronic pain: A pilot study. J Bodyw Mov Ther. 2024 Oct;40:1744-1751. doi: 10.1016/j.jbmt.2024.10.025. Epub 2024 Oct 15.
PubMed 39593518
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Chronic Pain, Kinesiophobia and Increased Physical Functionality in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05452499
- Acronym / sponsor ID
- Folio No.03-2022
- Conditions
- Breast Neoplasms, Pain, Chronic, Kinesiophobia, Breast Cancer
- Keywords
- Breast neoplasms, Breast cancer survivors, Chronic pain, Pain, Kinesiophobia, Pain neuroscience education, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Autónoma de YucatánUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pain neuroscience education and therapeutic exercise |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain neuroscience education and therapeutic exerciseParticipants 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). | Other | Intervention group |
Primary outcome
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.
3 secondary outcomes
Changes in 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.
Changes in physical functionality
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.
Shoulder range of motion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 39593518Lores-Peniche JA, Uicab Pool GLA, Aguinaga-Malanco S. Pain neuroscience education and therapeutic exercise for the treatment of sequelae in breast cancer survivors living with chronic pain: A pilot study. J Bodyw Mov Ther. 2024 Oct;40:1744-1751. doi: 10.1016/j.jbmt.2024.10.025. Epub 2024 Oct 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Antonio Lores, PT principal investigator
Universidad Autónoma de Yucatán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience education and therapeutic exercise in people with Breast Neoplasms and Pain, Chronic, run by Universidad Autónoma de Yucatán at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.