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Pain Neuroscience Education for Depression (PNEdepress)

Primary Purpose

Chronic Low-back Pain, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PNE edcuation
Sponsored by
St. Ambrose University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring chronic, Low-Back Pain, Depression

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kevin Farrell

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PNE education

Arm Description

All subjects will be tested before and after receiving PNE education

Outcomes

Primary Outcome Measures

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.
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.
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.
Patient Health Questionnaire - PHQ-9
The PHQ-9 is the nine item depression scale

Secondary Outcome Measures

Full Information

First Posted
July 11, 2019
Last Updated
January 13, 2023
Sponsor
St. Ambrose University
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1. Study Identification

Unique Protocol Identification Number
NCT04023435
Brief Title
Pain Neuroscience Education for Depression
Acronym
PNEdepress
Official Title
Pain Neuroscience Education for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Ambrose University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Depression
Keywords
chronic, Low-Back Pain, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
No other parties will be masked.
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNE education
Arm Type
Experimental
Arm Description
All subjects will be tested before and after receiving PNE education
Intervention Type
Other
Intervention Name(s)
PNE edcuation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Low back pain rating
Description
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.
Time Frame
within a single, 90 minute session
Title
Pain Catastrophization Scale
Description
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.
Time Frame
within a single, 90 minute session
Title
revised Pain Neurophysiology Questionnaire - rNPQ
Description
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.
Time Frame
within a single, 90 minute session
Title
Patient Health Questionnaire - PHQ-9
Description
The PHQ-9 is the nine item depression scale
Time Frame
within a single, 90 minute session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Farrell
Organizational Affiliation
St. Ambrose University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kevin Farrell
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Neuroscience Education for Depression

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