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

Chronic Low-back Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953454
• Other study ID #: USantoTomasChile
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Universidad Santo Tomas, Chile
• Contact: Joaquín I Salazar, MSc
• Phone: +569 73785287
• Email: jsalazar13[@]santotomas.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: December 30, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Santo Tomas, Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Employment status	employed versus unemployed	baseline
Other	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
Other	economic income	individual monthly taxable income	baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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