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.|
|ClinicalTrials.gov Identifier: NCT04023435|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low-back Pain Depression||Other: PNE edcuation||Not Applicable|
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 :||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.|
|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|
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).
- 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.
- 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.
- Patient Health Questionnaire - PHQ-9 [ Time Frame: within a single, 90 minute session ]The PHQ-9 is the nine item depression scale
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 ClinicalTrials.gov identifier (NCT number): NCT04023435
|Contact: Kevin Farrellfirstname.lastname@example.org|
|Contact: Adriaan Louw||515-722-2699||Adriaan@ispinstitute.com|
|United States, Iowa|
|Davenport, Iowa, United States, 52803|
|Contact: Kevin Farrell 563-333-6405 email@example.com|
|Principal Investigator:||Kevin Farrell||St. Ambrose University|