- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023435
Pain Neuroscience Education for Depression (PNEdepress)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Davenport, Iowa, United States, 52803
- Kevin Farrell
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PNE education
All subjects will be tested before and after receiving PNE education
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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within a single, 90 minute session
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Pain Catastrophization Scale
Time Frame: within a single, 90 minute session
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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.
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within a single, 90 minute session
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revised Pain Neurophysiology Questionnaire - rNPQ
Time Frame: within a single, 90 minute session
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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.
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within a single, 90 minute session
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Patient Health Questionnaire - PHQ-9
Time Frame: within a single, 90 minute session
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The PHQ-9 is the nine item depression scale
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within a single, 90 minute session
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1819307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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