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Pain Neuroscience Education for Depression (PNEdepress)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04023435
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Information provided by (Responsible Party):
Kevin Farrell, St. Ambrose University

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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Depression Other: PNE edcuation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: No other parties will be masked.
Primary Purpose: Treatment
Official Title: Pain Neuroscience Education for Depression
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: PNE education
All subjects will be tested before and after receiving PNE education
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).

Primary Outcome Measures :
  1. Low back pain rating [ Time Frame: within a single, 90 minute session ]
    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.

  2. Pain Catastrophization Scale [ Time Frame: within a single, 90 minute session ]
    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.

  3. revised Pain Neurophysiology Questionnaire - rNPQ [ Time Frame: within a single, 90 minute session ]
    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.

  4. Patient Health Questionnaire - PHQ-9 [ Time Frame: within a single, 90 minute session ]
    The PHQ-9 is the nine item depression scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04023435

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Contact: Kevin Farrell 563-333-6405
Contact: Adriaan Louw 515-722-2699

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United States, Iowa
Kevin Farrell Recruiting
Davenport, Iowa, United States, 52803
Contact: Kevin Farrell    563-333-6405   
Sponsors and Collaborators
St. Ambrose University
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Principal Investigator: Kevin Farrell St. Ambrose University

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Responsible Party: Kevin Farrell, Professor and Chair, Orthopaedic Residency Program in Physical Therapy, St. Ambrose University Identifier: NCT04023435     History of Changes
Other Study ID Numbers: 1819307
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevin Farrell, St. Ambrose University:
Low-Back Pain

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms