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

NCT ID: NCT05953454

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pain neuroscience Education

Intervention Type: OTHER

A pain neuroscience education session geared towards fear-avoidance beliefs

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.

Group Type: EXPERIMENTAL

Pain neuroscience Education

Intervention Type: OTHER

A pain neuroscience education session geared towards fear-avoidance beliefs

Control

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pain neuroscience Education

A pain neuroscience education session geared towards fear-avoidance beliefs

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Santo Tomas, Chile

OTHER

Sponsor Role: lead

Responsible Party

Joaquín Ignacio Salazar Méndez

adjunct teacher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquín I Salazar, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Santo Tomás

Central Contacts

Joaquín I Salazar, MSc

Role: CONTACT

jsalazar13@santotomas.cl

+569 73785287

Other Identifiers

USantoTomasChile

Identifier Type: -

Identifier Source: org_study_id