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Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pain neuroscience Education
Sponsored by
Universidad Santo Tomas, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring pain neuroscience education, physical therapy, chronic pain

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: non-specific low back pain ≥ 3 months without compromise of any lower limb. average pain intensity ≥ 3/10 and ≤8/10 (according to the 0-10 numerical rating scale [NRS]) in the last month. Exclusion Criteria: psychiatric, neurological or oncological diseases. operated of some lumbar pathology chronic low back pain due to a specific cause (lumbar stenosis, herniated disc, spinal deformity, fracture, spondylosis) have received any modality of active or passive physical therapy for pain in the last two months, previous experiences with PNE

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Group Pain Neuroscience Education

    Individual Pain Neuroscience Education

    Control

    Arm Description

    A single face-to-face group session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through). With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation.

    A single one-on-one face-to-face session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through). With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation.

    no intervention

    Outcomes

    Primary Outcome Measures

    Changes in Fear avoidance beliefs
    The Fear Avoidance Beliefs Questionnaire consists of two subscales: (1) a 7-item work subscale (FABQ-W) and (2) a 4-item physical activity subscale (FABQ-P). Both subscales score on a Likert-type scale from 0 to 6 points on each item. Higher scores indicate higher levels of fear-avoidance beliefs.
    changes in pressure pain sensitivity
    An algometer will be used to measure pressure pain sensitivity (SPD), which is defined as the amount of applied pressure required for a subject to report the onset of pain sensation. It will be applied three times for each moment of evaluation and the average of the three applications will be considered. The unit of measure kg/cm2/s will be used.

    Secondary Outcome Measures

    Changes in Pain Self-efficacy
    Cain self-efficacy questionnaire (PSEQ) consists of 10 items rated on a 7-point Likert scale from 0 ("not at all sure") to 6 ("very sure"). Higher scores indicate stronger self-efficacy beliefs, while low scores indicate a subject more focused on their pain.
    Changes in Catastrophizing
    Pain Catastrophizing Scale (PCS) consists of 13 items on a 5-point Likert scale ranging from (0) never to (4) all the time. Higher scores indicate more catastrophic thoughts.
    Changes in Pain intensity
    Numerical Rating Scale (NRS). It consists of a number line from 0 to 10. Higher scores indicate greater intensity of pain.
    Treatment expectation
    The treatment expectation questionnaire (TEX-Q). This questionnaire consists of 15 questions with a Likert scale of 0-10. higher scores indicate a better expectation of treatment.

    Full Information

    First Posted
    July 1, 2023
    Last Updated
    July 19, 2023
    Sponsor
    Universidad Santo Tomas, Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05953454
    Brief Title
    Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain
    Official Title
    Effectiveness of Group Versus Individual Pain Neuroscience Education on Clinical and Psychosocial Outcomes in Patients With Chronic Low Back Pain: Protocol of a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2024 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Santo Tomas, Chile

    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
    An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain. The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined. The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups. Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low-back Pain
    Keywords
    pain neuroscience education, physical therapy, chronic pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    69 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Pain Neuroscience Education
    Arm Type
    Experimental
    Arm Description
    A single face-to-face group session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through). With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation.
    Arm Title
    Individual Pain Neuroscience Education
    Arm Type
    Experimental
    Arm Description
    A single one-on-one face-to-face session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through). With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    no intervention
    Intervention Type
    Other
    Intervention Name(s)
    Pain neuroscience Education
    Intervention Description
    A pain neuroscience education session geared towards fear-avoidance beliefs
    Primary Outcome Measure Information:
    Title
    Changes in Fear avoidance beliefs
    Description
    The Fear Avoidance Beliefs Questionnaire consists of two subscales: (1) a 7-item work subscale (FABQ-W) and (2) a 4-item physical activity subscale (FABQ-P). Both subscales score on a Likert-type scale from 0 to 6 points on each item. Higher scores indicate higher levels of fear-avoidance beliefs.
    Time Frame
    baseline, 1-week post-intervention, and 4 -weeks post-intervention
    Title
    changes in pressure pain sensitivity
    Description
    An algometer will be used to measure pressure pain sensitivity (SPD), which is defined as the amount of applied pressure required for a subject to report the onset of pain sensation. It will be applied three times for each moment of evaluation and the average of the three applications will be considered. The unit of measure kg/cm2/s will be used.
    Time Frame
    baseline, 1-week post-intervention, and 4 -weeks post-intervention
    Secondary Outcome Measure Information:
    Title
    Changes in Pain Self-efficacy
    Description
    Cain self-efficacy questionnaire (PSEQ) consists of 10 items rated on a 7-point Likert scale from 0 ("not at all sure") to 6 ("very sure"). Higher scores indicate stronger self-efficacy beliefs, while low scores indicate a subject more focused on their pain.
    Time Frame
    baseline, 1-week post-intervention, and 4 -weeks post-intervention
    Title
    Changes in Catastrophizing
    Description
    Pain Catastrophizing Scale (PCS) consists of 13 items on a 5-point Likert scale ranging from (0) never to (4) all the time. Higher scores indicate more catastrophic thoughts.
    Time Frame
    baseline, 1-week post-intervention, and 4 -weeks post-intervention
    Title
    Changes in Pain intensity
    Description
    Numerical Rating Scale (NRS). It consists of a number line from 0 to 10. Higher scores indicate greater intensity of pain.
    Time Frame
    baseline, 1-week post-intervention, and 4 -weeks post-intervention
    Title
    Treatment expectation
    Description
    The treatment expectation questionnaire (TEX-Q). This questionnaire consists of 15 questions with a Likert scale of 0-10. higher scores indicate a better expectation of treatment.
    Time Frame
    baseline
    Other Pre-specified Outcome Measures:
    Title
    Employment status
    Description
    employed versus unemployed
    Time Frame
    baseline
    Title
    Educational level
    Description
    participants were assigned to the lower educational level if they had not completed secondary education and to the higher educational level if they had completed secondary education or university studies
    Time Frame
    baseline
    Title
    economic income
    Description
    individual monthly taxable income
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: non-specific low back pain ≥ 3 months without compromise of any lower limb. average pain intensity ≥ 3/10 and ≤8/10 (according to the 0-10 numerical rating scale [NRS]) in the last month. Exclusion Criteria: psychiatric, neurological or oncological diseases. operated of some lumbar pathology chronic low back pain due to a specific cause (lumbar stenosis, herniated disc, spinal deformity, fracture, spondylosis) have received any modality of active or passive physical therapy for pain in the last two months, previous experiences with PNE
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joaquín I Salazar, MSc
    Phone
    +569 73785287
    Email
    jsalazar13@santotomas.cl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joaquín I Salazar, MSc
    Organizational Affiliation
    Universidad Santo Tomás
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all collected IPD, all IPD that underlie results in a publication
    IPD Sharing Time Frame
    from 6 months after publication. They will be available for one year.
    IPD Sharing Access Criteria
    will be provided to any researcher who requires it via email

    Learn more about this trial

    Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain

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