Chronic Low-back PainPNEdepressNCT04023435
Pain Neuroscience Education for Depression
A study testing PNE edcuation in people with Chronic Low-back Pain and Depression, run by St. Ambrose University at 1 site in United States.
Trial summary
This study will look at the effects of Pain Neuroscience Education on a Depression outcome tool in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain, Depression
- What is being tested?
- PNE edcuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 5 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study will look at the effects of Pain Neuroscience Education on a Depression outcome tool in patients with chronic low back pain.
Read the 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
- Being tested
- PNE edcuation
- Keywords
- chronic, Low-Back Pain, Depression
- Medical subject headings
- Depression, Bronchiolitis Obliterans Syndrome, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNE edcuationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| PNE education | Experimental | All subjects will be tested before and after receiving PNE education Receives: Other: PNE edcuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain rating
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.
Measured: within a single, 90 minute session
Pain Catastrophization Scale
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.
Measured: within a single, 90 minute session
revised Pain Neurophysiology Questionnaire - rNPQ
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.
Measured: within a single, 90 minute session
Patient Health Questionnaire - PHQ-9
The PHQ-9 is the nine item depression scale
Measured: within a single, 90 minute session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Jun 2019
- Primary completion1 Sep 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Ambrose University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Farrell, St. Ambrose University
- Investigators
- Kevin Farrell, Principal investigator, St. Ambrose University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023435
- Sponsor's protocol ID
- 1819307
- Acronym
- PNEdepress
- Status last verified
- Jan 2023
- First submitted
- 11 Jul 2019
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education for Depression
- ClinicalTrials.gov ID
- NCT04023435
- Acronym / sponsor ID
- PNEdepress / 1819307
- Conditions
- Chronic Low-back Pain, Depression
- Keywords
- chronic, Low-Back Pain, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Ambrose UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PNE education | Experimental | Other: PNE edcuationAll subjects will be tested before and after receiving PNE education |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNE edcuationThe 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). | Other | PNE education |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Farrell principal investigator
St. Ambrose University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNE edcuation in people with Chronic Low-back Pain and Depression, run by St. Ambrose University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain rating (time frame: within a single, 90 minute session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.