Pain Neuroscience Education for Depression

Depression Clinical Trial

— PNEdepress  

Official title:

Pain Neuroscience Education for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023435
• Other study ID #: 1819307
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: January 2023
• Source: St. Ambrose University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 5, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Depression
• Depressive Disorder
• Low Back Pain

Intervention

Other:
• PNE edcuation
The PNE session will last 30 minutes and will be delivered in a one-on-one educational format with a clinician using prepared images, drawings and metaphors. The 30-minute PNE session was chosen to reflect a clinically meaningful intervention in a typical allocated time frame in clinical practice. The content of the PNE is described in detail elsewhere, using a metaphors to explain various aspects of pain including sensitization of the peripheral and central nervous system (sensitive alarm system metaphor); spreading pain (nosy neighbors metaphor); increases problems with focus and concentration (brain meeting metaphor) and difficulty with fatigue and sleep (lion metaphor).

Locations

Country	Name	City	State
United States	Kevin Farrell	Davenport	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
St. Ambrose University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain rating	Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.	within a single, 90 minute session
Primary	Pain Catastrophization Scale	The PCS is a self-report questionnaire assessing inappropriate coping strategies and catastrophic thinking about pain and injury. on a 13-item, 5-point Likert scale with higher scores indicating elevated levels of catastrophizing.	within a single, 90 minute session
Primary	revised Pain Neurophysiology Questionnaire - rNPQ	The NPQ measures the neurophysiology knowledge of patients and healthcare personnel. The original NPQ is a 19-item questionnaire requesting 'true'; 'false'; or 'not sure' answers to statements, with higher scores indicating more correct answers.	within a single, 90 minute session
Primary	Patient Health Questionnaire - PHQ-9	The PHQ-9 is the nine item depression scale	within a single, 90 minute session