Clinical trial NCT05953454: Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: pain neuroscience education
physical therapy
chronic pain
Lead sponsor: Universidad Santo Tomas, Chile
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 69
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in Fear avoidance beliefs
timeFrame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
measure: changes in pressure pain sensitivity
timeFrame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Secondary outcomes:
measure: Changes in Pain Self-efficacy
timeFrame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
measure: Changes in Catastrophizing
timeFrame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
measure: Changes in Pain intensity
timeFrame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
measure: Treatment expectation
timeFrame: baseline
Other outcomes:
measure: Employment status
timeFrame: baseline
measure: Educational level
timeFrame: baseline
measure: economic income
timeFrame: baseline
Locations:
Study officials:
affiliation: Universidad Santo Tomás
name: Joaquín I Salazar, MSc
role: PRINCIPAL_INVESTIGATOR
References: