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Effectiveness of a Pain Neuroscience Education Program in Adults With Cancer Pain

Primary Purpose

Cancer Pain

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pain neuroscience education
Conventional management or Usual care
Sponsored by
Instituto Neurociencia Del Dolor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain focused on measuring Pain Neuroscience education, Cancer pain, Paliative therapy, Neoplasm

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a life expectancy of more than three months (Karnofski Scales (KPS), Eastern Cooperative Oncology Group Scale (ECOG), survival prognosis PAP score, Palliative Prognosis Index PPI).
  • Acceptance of informed consent.
  • Educational level (high school diploma).
  • No pain hospitalizations in the previous month
  • Capable of establishing a team communication process
  • at least 21 points on the MOCA scale for preserved cognitive function
  • Understanding of the Spanish language.

Exclusion Criteria:

  • Surgery scheduled within the next three months
  • Visual and auditory sensory system deficiency (deafness or blindness).
  • The presence of a recent traumatic injury
  • Atrial or ventricular arrhythmias that are uncontrolled.
  • Aortic aneurysm dissection
  • Aortic stenosis severe
  • Endocarditis or pericarditis that is acute
  • Uncontrollable hypertension
  • Thromboembolic disease, acute.
  • Acute severe heart failure
  • Acute severe respiratory failure
  • Fracture within the last month

Sites / Locations

  • Universidad Arturo Prat
  • Universidad Santiago de CaliRecruiting
  • Clinica de OccidenteRecruiting
  • Instituto Neurociencia del Dolor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pain neuroscience education.

Conventional treatment or Usual Care

Arm Description

This consists of generating elements from neurobiology and neurophysiology for the understanding of pain from the development of metaphors.

Pharmacological treatment and indications estimated by a specialist in palliative care and pain.

Outcomes

Primary Outcome Measures

Change in Brief Pain Inventory (Impact of pain)
The BPI or brief pain questionnaire is a self-administered questionnaire that contains two dimensions: one related to the intensity of pain and the impact of pain on the activities of the patient's life. Its use has increased in the evaluation of patients with cancer pain. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. the higher the score, the greater the severity of the pain.
Change in Visual Analog Scale-Pain (EVA)
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.

Secondary Outcome Measures

Change in Central Sensitization Inventory Score (CSI)
Central Sensitization Inventory (CSI) is a scale used to detect patients with symptoms associated with central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension type headache, migraine. The Central Sensitization Inventory (CSI) consists of two parts: Part A consists of 25 questions about central sensitization syndrome (CNS) symptoms; Section B examines the patient's condition of being diagnosed with certain CNS diseases or CNS related diseases such as anxiety and depression. The patient answers 25 questions in section A with a score between 0 and 4. The total score will be between 0-100. Results above 40 points indicate central sensitization.
Change in Pain Catastrophizing Scale (PCS)
The PCS is measured with a self-administered questionnaire. Is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
Change in Tampa Scale for Kinesiophobia (TSK-11)
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Change in Beck Depression Inventory Score
Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.It contains 21 categories to measure physical, emotional, cognitive and motivational symptoms such as hopelessness, irritability, guilt, feeling of punishment, fatigue, and weight loss in each depression, and each category is scored between 0-3. The patient is asked to mark the most appropriate one for the four options in each category. Scoring progressively increases from the absence of symptoms to severe symptoms. 0-10 points: No depression, 11-17 points: Mild depression, 18-23 points: Moderate depression, 24 and above points: Severe depression.
Change in DN4 neuropathic pain
We will work with the DN4 scale that evaluates 4 questions with a possibility of being qualified up to 10 points to determine the presence of neuropathic pain.
Change in Moca test Cognitive function
It is made up of 19 items and eight cognitive domains that assess skills such as visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. a maximum score of 30, with the cut-off points for cognitive impairment being 25/26.
Change in EORTC QLQ C-30 Quality of life
has been defined as the way in which the individual perceives his/her place in life, The standard model consists of 14 domains and an empirical solution with five domains (physical, psychological, frailty, socioeconomic, and global score). This widely used questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social function), a global quality of life (QoL) scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six individual. items (loss of appetite, diarrhea, dyspnea, constipation, insomnia, economic impact). For the functional and global quality of life scales, a higher score indicates better health. For the symptom scales, a higher score indicates a higher symptom burden.
Change in Sleep quality Pittsburgh Sleep Quality Index
This is one of the most reliable tests to define the quality of sleep and its disorders. It contains a total of 19 questions, grouped into 10 questions. The questions are combined to form seven areas with their corresponding score, each one of which shows a range between 0 and 3 points.

Full Information

First Posted
October 1, 2022
Last Updated
June 13, 2023
Sponsor
Instituto Neurociencia Del Dolor
Collaborators
Universidad Santiago de Cali, Clinica de Occidente
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1. Study Identification

Unique Protocol Identification Number
NCT05581784
Brief Title
Effectiveness of a Pain Neuroscience Education Program in Adults With Cancer Pain
Official Title
The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Neurociencia Del Dolor
Collaborators
Universidad Santiago de Cali, Clinica de Occidente

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
IASP defines "pain" as "an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage". In some patients, pain is one of the reasons they initially consult a doctor and will be strongly related to cancer itself, is connected to receiving the cancer diagnosis, and therefore may become an uncertain threat of disease recurrence in cancer survivors. Neuropathic pain is the most prevalent type of pain, but a mixed type of pain is also common, reflecting the complexity of the pain experience. There is increasing evidence in oncology that quality of life and survival are linked to early and effective palliative care, including pain management. Although improvements have been seen, undertreatment of pain remains a problem in a significant subset of cancer patients. Regarding the interventional options in cancer pain, multiple possibilities range from pharmacological modulation, the use of modalities or physical means, as well as the practice of physical exercise as a mechanism of pain modulation, which has been established according to the background grade of recommendation. Regarding education in neuroscience, this has gained momentum in chronic pain since previous interventions have generated recommendations to include neurocognitive interventions in pain processes. Therefore, it seeks to determine the effectiveness of a neuroscience education program compared to conventional treatment in adults with cancer pain in biopsychosocial variables.
Detailed Description
A parallel group randomized controlled clinical trial will be conducted during the months of November 2022 to December 2023. The proposed research will be a quantitative experimental design type controlled clinical trial following the SPIRIT guidelines for clinical trial protocols and CONSORT for the execution of clinical trials. A total of 80 patients, where 40 will be assigned to (PNE) and 40 to conventional management. experimental group: based on education in neuroscience of pain for 9 sessions in a period of 10 weeks. Work will be done to prepare the content for an adapted and illustrated guide as a complementary material for patients. An expert judgment test will be carried out to validate the content of the material. Each patient must complete at least 8 sessions to comply with the protocol. These sessions will be personalized and will include the guide as complementary material for each session. This group remains with pharmacological treatment and the usual guidelines given by the doctor. Results will be assessed at baseline (t1) and at week 10 (t2). Written informed consent will be obtained from all participants prior to their participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Pain Neuroscience education, Cancer pain, Paliative therapy, Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Masking: Simple (result evaluator)
Masking
InvestigatorOutcomes Assessor
Masking Description
Simple (result evaluator)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain neuroscience education.
Arm Type
Experimental
Arm Description
This consists of generating elements from neurobiology and neurophysiology for the understanding of pain from the development of metaphors.
Arm Title
Conventional treatment or Usual Care
Arm Type
Other
Arm Description
Pharmacological treatment and indications estimated by a specialist in palliative care and pain.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education
Other Intervention Name(s)
Explaining Pain, Therapeutic Neuroscience Education
Intervention Description
PNE sessions will be led by an experienced physical therapist certified in PNE in 35-minute face-to-face group sessions. Here elements of the neurophysiology of pain are addressed, as well as the different psychosocial dimensions that influence it. The distribution of themes will be carried out as follows: Week One: Coping with Pain. Week 2: Pain and Cognition Week 3: Your security system Week 4: Altered Alarm System (extra sensitive). Week 5: The defense system is in distress. Week 6: Fatigue, anxiety, and stress Week 7: Current Models of Treatment Week 8: Achievements and goals Week 9: Pain emphasis and differentiation This group remains with pharmacological treatment and the usual guidelines given by the doctor.
Intervention Type
Other
Intervention Name(s)
Conventional management or Usual care
Other Intervention Name(s)
Usual care, Conventional management
Intervention Description
This group will only have pharmacological treatment and the usual guidelines given by the doctor. Without educational intervention.
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory (Impact of pain)
Description
The BPI or brief pain questionnaire is a self-administered questionnaire that contains two dimensions: one related to the intensity of pain and the impact of pain on the activities of the patient's life. Its use has increased in the evaluation of patients with cancer pain. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. the higher the score, the greater the severity of the pain.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Visual Analog Scale-Pain (EVA)
Description
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
Time Frame
At baseline and through intervention's completion, 10 weeks
Secondary Outcome Measure Information:
Title
Change in Central Sensitization Inventory Score (CSI)
Description
Central Sensitization Inventory (CSI) is a scale used to detect patients with symptoms associated with central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension type headache, migraine. The Central Sensitization Inventory (CSI) consists of two parts: Part A consists of 25 questions about central sensitization syndrome (CNS) symptoms; Section B examines the patient's condition of being diagnosed with certain CNS diseases or CNS related diseases such as anxiety and depression. The patient answers 25 questions in section A with a score between 0 and 4. The total score will be between 0-100. Results above 40 points indicate central sensitization.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Pain Catastrophizing Scale (PCS)
Description
The PCS is measured with a self-administered questionnaire. Is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Tampa Scale for Kinesiophobia (TSK-11)
Description
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Beck Depression Inventory Score
Description
Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.It contains 21 categories to measure physical, emotional, cognitive and motivational symptoms such as hopelessness, irritability, guilt, feeling of punishment, fatigue, and weight loss in each depression, and each category is scored between 0-3. The patient is asked to mark the most appropriate one for the four options in each category. Scoring progressively increases from the absence of symptoms to severe symptoms. 0-10 points: No depression, 11-17 points: Mild depression, 18-23 points: Moderate depression, 24 and above points: Severe depression.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in DN4 neuropathic pain
Description
We will work with the DN4 scale that evaluates 4 questions with a possibility of being qualified up to 10 points to determine the presence of neuropathic pain.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Moca test Cognitive function
Description
It is made up of 19 items and eight cognitive domains that assess skills such as visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. a maximum score of 30, with the cut-off points for cognitive impairment being 25/26.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in EORTC QLQ C-30 Quality of life
Description
has been defined as the way in which the individual perceives his/her place in life, The standard model consists of 14 domains and an empirical solution with five domains (physical, psychological, frailty, socioeconomic, and global score). This widely used questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social function), a global quality of life (QoL) scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six individual. items (loss of appetite, diarrhea, dyspnea, constipation, insomnia, economic impact). For the functional and global quality of life scales, a higher score indicates better health. For the symptom scales, a higher score indicates a higher symptom burden.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Sleep quality Pittsburgh Sleep Quality Index
Description
This is one of the most reliable tests to define the quality of sleep and its disorders. It contains a total of 19 questions, grouped into 10 questions. The questions are combined to form seven areas with their corresponding score, each one of which shows a range between 0 and 3 points.
Time Frame
At baseline and through intervention's completion, 10 weeks
Other Pre-specified Outcome Measures:
Title
Change in 6-minute walk test
Description
It is performed to determine exercise tolerance and specify functional status. This evaluates the number of meters traveled during the last 6 minutes.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in grip strength
Description
It is a marker of nutritional status and a marker of morbidity and mortality of the pathology. It will be measured with a dynamometer to establish the grip strength value in kilograms.
Time Frame
At baseline and through intervention's completion, 10 weeks
Title
Change in Test Get up and Go
Description
This test has been developed, finding that it has been a predictor of falls and as a measure of functional capacity. n this test, the participant starts in a chair, stands up, runs three meters, and sits down again. The time of the execution of the test is taken.
Time Frame
At baseline and through intervention's completion, 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a life expectancy of more than three months (Karnofski Scales (KPS), Eastern Cooperative Oncology Group Scale (ECOG), survival prognosis PAP score, Palliative Prognosis Index PPI). Acceptance of informed consent. Educational level (high school diploma). No pain hospitalizations in the previous month Capable of establishing a team communication process at least 21 points on the MOCA scale for preserved cognitive function Understanding of the Spanish language. Exclusion Criteria: Surgery scheduled within the next three months Visual and auditory sensory system deficiency (deafness or blindness). The presence of a recent traumatic injury Atrial or ventricular arrhythmias that are uncontrolled. Aortic aneurysm dissection Aortic stenosis severe Endocarditis or pericarditis that is acute Uncontrollable hypertension Thromboembolic disease, acute. Acute severe heart failure Acute severe respiratory failure Fracture within the last month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leidy Tatiana Ordoñez-Mora, MSC
Phone
573159262968
Email
leidy.ordonez01@usc.edu.co
Facility Information:
Facility Name
Universidad Arturo Prat
City
Iquique
ZIP/Postal Code
1110939
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Universidad Santiago de Cali
City
Cali
State/Province
Valle
ZIP/Postal Code
760033
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leidy Tatiana Ordoñez-Mora
Phone
573159262968
Email
tatiana.ormora@gmail.com
First Name & Middle Initial & Last Name & Degree
Leidy Tatiana Ordoñez-Mora, MSC
First Name & Middle Initial & Last Name & Degree
Ilem Dayana Rosero-Rosero, PhD
Facility Name
Clinica de Occidente
City
Cali
State/Province
Valle
ZIP/Postal Code
760046
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Avila Valencia, MSC
Phone
573013369979
Email
rhcardiopulmonar09@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Carlos Avila-Valencia, MSC
First Name & Middle Initial & Last Name & Degree
Julian Alberto Agudelo, MSC
Facility Name
Instituto Neurociencia del Dolor
City
Puebla
ZIP/Postal Code
72000
Country
Mexico
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30606621
Citation
Nijs J, Wijma AJ, Leysen L, Pas R, Willaert W, Hoelen W, Ickmans K, Wilgen CPV. Explaining pain following cancer: a practical guide for clinicians. Braz J Phys Ther. 2019 Sep-Oct;23(5):367-377. doi: 10.1016/j.bjpt.2018.12.003. Epub 2018 Dec 21.
Results Reference
background
PubMed Identifier
23303884
Citation
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
Results Reference
background
PubMed Identifier
20332511
Citation
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
Results Reference
background
Links:
URL
https://www.iasp-pain.org/
Description
Pain definition

Learn more about this trial

Effectiveness of a Pain Neuroscience Education Program in Adults With Cancer Pain

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