Pain Neuroscience Education for Depression

NCT04023435 | Completed

• 1 other identifier: 1819307
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Depression

Keywords

chronic; Low-Back Pain; Depression

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Patient Health Questionnaire - PHQ-9

  The PHQ-9 is the nine item depression scale

  within a single, 90 minute session

Study Arms (1)

PNE education

EXPERIMENTAL

All subjects will be tested before and after receiving PNE education

Other: PNE edcuation

Interventions

PNE edcuation OTHER

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).

PNE education

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Ambrose University: lead

Study Sites (1)

Kevin Farrell

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Depression; Bronchiolitis Obliterans Syndrome; Low Back Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Farrell

  St. Ambrose University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No other parties will be masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Orthopaedic Residency Program in Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 17, 2019
• Study Start: June 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: November 5, 2019
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)