Pain Neuroscience Education for Depression

NCT ID: NCT04023435

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-11-05

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.

Conditions

Chronic Low-back Pain; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PNE education

All subjects will be tested before and after receiving PNE education

Group Type: EXPERIMENTAL

PNE edcuation

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Ambrose University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Farrell

Professor and Chair, Orthopaedic Residency Program in Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Farrell

Role: PRINCIPAL_INVESTIGATOR

St. Ambrose University

Locations

Kevin Farrell

Davenport, Iowa, United States

Countries

United States

Other Identifiers

1819307

Identifier Type: -

Identifier Source: org_study_id