Clinical trial NCT04023435: Pain Neuroscience Education for Depression
Official title: Pain Neuroscience Education for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Depression
Keywords: chronic
Low-Back Pain
Depression
Lead sponsor: St. Ambrose University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a pre- and post-intervention convenience sample of consecutive patients with chronic LBP (pain \> 6 months) meeting the inclusion criteria, attending outpatient PT. On initial examination, intake data and information will be collected prior to PNE and immediately following PNE.
Primary purpose: TREATMENT

Brief summary: This study will look at the effects of Pain Neuroscience Education on a Depression outcome tool in patients with chronic low back pain.

Detailed description: Pain and depression have been shown to be interrelated, especially chronic pain: people in chronic pain develop depression and people with depression develop chronic pain. In light of this coexistence it is not surprising that current best-evidence for depression and chronic pain shows significant overlap which includes primarily some type of cognitive intervention, aerobic exercise, and skilled delivery of medication including selective-serotonin-reuptake-inhibitors and/or membrane stabilizers. Current best-evidence regarding musculoskeletal pain provides strong support for Pain Neuroscience Education (PNE) to positively influence pain ratings, dysfunction, and limitations in movement, pain knowledge and healthcare utilization. Additionally, PNE has shown to powerfully influence psychosocial issues that powerfully influence pain and depression: fear-avoidance and pain catastrophization. Evidence is lacking in whether PNE could also influence depression ratings. The purpose of this study is to examine the immediate effect of PNE on pain, function, and depressive symptoms (using the Patient Health Questionnaire - PHQ-9) in patients attending PT for chronic low back pain (LBP).

This will be a pre- and post-intervention convenience sample of consecutive patients with chronic LBP (pain \> 6 months) meeting the inclusion criteria, attending outpatient PT. On initial examination, intake data and information will be collected prior to PNE and immediately following PNE.

Eligibility criteria: Inclusion Criteria:

* adults over the age of 18
* presenting at PT with a primary complaint of LBP
* LBP being present for 6 months or more
* fluent in English
* willing to participate in the study.

Exclusion Criteria:

* are under age 18 (minor)
* had undergone lumbar surgery
* cannot read or understand the English language
* presents with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.)
* decline to participate
* present with a medical etiology (red flag) associated with their LBP.

Primary outcomes:
measure: Low back pain rating
timeFrame: within a single, 90 minute session
measure: Pain Catastrophization Scale
timeFrame: within a single, 90 minute session
measure: revised Pain Neurophysiology Questionnaire - rNPQ
timeFrame: within a single, 90 minute session
measure: Patient Health Questionnaire - PHQ-9
timeFrame: within a single, 90 minute session
Secondary outcomes:
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Kevin Farrell
state: Iowa
Study officials:
affiliation: St. Ambrose University
name: Kevin Farrell
role: PRINCIPAL_INVESTIGATOR
References: