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Clinical Trials/NCT04023435
NCT04023435CompletedNot Applicable

Pain Neuroscience Education for Depression

St. Ambrose University2 sites in 1 country30 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Patient Health Questionnaire - PHQ-9

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

No other parties will be masked.

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

Patient Health Questionnaire - PHQ-9

Time Frame: within a single, 90 minute session

The PHQ-9 is the nine item depression scale

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kevin Farrell

Professor and Chair, Orthopaedic Residency Program in Physical Therapy

St. Ambrose University

Study Sites (2)

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