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

NCT05953454 | Unknown

• 1 other identifier: USantoTomasChile
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low-back Pain

Keywords

pain neuroscience education; physical therapy; chronic pain

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, 1-week post-intervention, and 4 -weeks post-intervention

• 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.

  baseline, 1-week post-intervention, and 4 -weeks post-intervention

Secondary Outcomes (4)

• Changes in Pain Self-efficacy

  baseline, 1-week post-intervention, and 4 -weeks post-intervention

• Changes in Catastrophizing

  baseline, 1-week post-intervention, and 4 -weeks post-intervention

• Changes in Pain intensity

  baseline, 1-week post-intervention, and 4 -weeks post-intervention

• Treatment expectation

  baseline

Other Outcomes (3)

• Employment status

  baseline

• Educational level

  baseline

• economic income

  baseline

Study Arms (3)

Group Pain Neuroscience Education

EXPERIMENTAL

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

Individual Pain Neuroscience Education

EXPERIMENTAL

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

Control

NO INTERVENTION

no intervention

Interventions

Pain neuroscience Education OTHER

A pain neuroscience education session geared towards fear-avoidance beliefs

Group Pain Neuroscience Education; Individual Pain Neuroscience Education

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Santo Tomas, Chile: lead

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joaquín I Salazar, MSc

  Universidad Santo Tomás

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquín I Salazar, MSc

CONTACT

+569 73785287; jsalazar13@santotomas.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct teacher

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 20, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from 6 months after publication. They will be available for one year.
• Access Criteria: will be provided to any researcher who requires it via email