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

Sponsor
Universidad Santo Tomas, Chile (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05953454
Collaborator
(none)
69
3
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pain neuroscience Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Pain Neuroscience Education

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.

Other: Pain neuroscience Education
A pain neuroscience education session geared towards fear-avoidance beliefs

Experimental: Individual Pain Neuroscience Education

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.

Other: Pain neuroscience Education
A pain neuroscience education session geared towards fear-avoidance beliefs

No Intervention: Control

no intervention

Outcome Measures

Primary Outcome Measures

  1. Changes in Fear avoidance beliefs [baseline, 1-week post-intervention, and 4 -weeks post-intervention]

    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.

  2. changes in pressure pain sensitivity [baseline, 1-week post-intervention, and 4 -weeks post-intervention]

    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

  1. Changes in Pain Self-efficacy [baseline, 1-week post-intervention, and 4 -weeks post-intervention]

    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.

  2. Changes in Catastrophizing [baseline, 1-week post-intervention, and 4 -weeks post-intervention]

    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.

  3. Changes in Pain intensity [baseline, 1-week post-intervention, and 4 -weeks post-intervention]

    Numerical Rating Scale (NRS). It consists of a number line from 0 to 10. Higher scores indicate greater intensity of pain.

  4. Treatment expectation [baseline]

    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.

Other Outcome Measures

  1. Employment status [baseline]

    employed versus unemployed

  2. Educational level [baseline]

    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

  3. economic income [baseline]

    individual monthly taxable income

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidad Santo Tomas, Chile

Investigators

  • Principal Investigator: Joaquín I Salazar, MSc, Universidad Santo Tomás

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joaquín Ignacio Salazar Méndez, adjunct teacher, Universidad Santo Tomas, Chile
ClinicalTrials.gov Identifier:
NCT05953454
Other Study ID Numbers:
  • USantoTomasChile
First Posted:
Jul 20, 2023
Last Update Posted:
Jul 20, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joaquín Ignacio Salazar Méndez, adjunct teacher, Universidad Santo Tomas, Chile
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2023