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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Pain neuroscience Education

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joaquín I Salazar, MSc; Phone Number: +569 73785287; Email: jsalazar13@santotomas.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; no intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 1-week post-intervention, and 4 -weeks post-intervention
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.	baseline, 1-week post-intervention, and 4 -weeks post-intervention
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.	baseline, 1-week post-intervention, and 4 -weeks post-intervention
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.	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Employment status	employed versus unemployed	baseline
Educational level	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	baseline
economic income	individual monthly taxable income	baseline

Collaborators and Investigators

• Sponsor: Universidad Santo Tomas, Chile
• Investigators: Principal Investigator: Joaquín I Salazar, MSc, Universidad Santo Tomás

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; physical therapy; pain neuroscience education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: USantoTomasChile

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No