Low Back PainNCT03722394
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain
A study testing Pain Neuroscience Education in people with Low Back Pain and Pain, Chronic, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
To determine if Pain Neuroscience Education (PNE) would result in positive clinical changes in patients presenting with acute or sub-acute low back pain (LBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Pain, Chronic, Pain, Back
- What is being tested?
- Pain Neuroscience Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 30 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a complaint of LBP with or without leg pain less than 3 months, and
- a willingness to participate
Who cannot join
- a) were under age 18 (minor);
- b) had undergone lumbar surgery;
- c) could not read or understand the English language;
- d) presented with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.),
- e) declined to participate or
- f) presented with a medical etiology (red flag) associated with their LBP.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89178
About this study
Official title: Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series
To determine if Pain Neuroscience Education (PNE) would result in positive clinical changes in patients presenting with acute or sub-acute low back pain (LBP).
Read the detailed description
Background: Pain neuroscience education (PNE) has shown efficacy in treating chronic pain. Clinicians may believe PNE is not suitable for acute and sub-acute pain. Subgroupings of low back pain (LBP) imply some patients with LBP may respond favorably to PNE.
Objective: To determine if PNE would result in positive clinical changes in patients presenting with acute or sub-acute LBP.
Methods: Eighty consecutive patients with LBP < 3 months were enrolled in the study. Patients completed a demographics questionnaire, leg and LBP rating (Numeric Pain Rating Scale - NPRS), disability (Oswestry Disability Index), fear-avoidance (Fear-Avoidance Beliefs Questionnaire), pain catastrophization (Pain Catastrophization Scale), central sensitization (Central Sensitization Inventory), pain knowledge (Revised Neurophysiology of Pain Questionnaire), risk assessment (Keele STarT Back Screening Tool), active trunk flexion and straight leg raise (SLR). Patients received a 15-minute verbal, one-on-one PNE session, followed by repeat measurement of LBP and leg pain (NPRS), trunk flexion and SLR.
- Conditions
- Low Back Pain, Pain, Chronic, Pain, Back
- Being tested
- Pain Neuroscience Education
- Medical subject headings
- Low Back Pain, Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationBehavioural
15 minute verbal one-on-one education session
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education | Experimental | Subjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session Receives: Behavioral: Pain Neuroscience Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS - LBP
Numeric Pain Rating Scale for Low Back Pain (Range 0 = no pain to 11 = maximum pain)
Measured: Immediate change from baseline after assigned intervention
NPRS - Leg pain
Numeric Pain Rating Scale for leg pain (Range 0 = no pain to 11 = maximum pain)
Measured: Immediate change from baseline after assigned intervention
Secondary outcomes (2)
Active trunk flexion
Active trunk flexion measured in centimeters from fingertips to floor
Measured: Immediate change from baseline in centimeters after assigned intervention
Passive Straight Leg Raise
Range of hip flexion angle during passive straight leg raise test measured in degrees
Measured: Immediate change from baseline in angular degrees after assigned intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start10 Jan 2018
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational cohort
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- St. Ambrose University
- Responsible party
- Principal investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
- Investigators
- Kevin Farrell, PhD, Principal investigator, St. Ambrose University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722394
- Sponsor's protocol ID
- 1202-4022
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 26 Oct 2018
- 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 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series
- ClinicalTrials.gov ID
- NCT03722394
- Acronym / sponsor ID
- 1202-4022
- Conditions
- Low Back Pain, Pain, Chronic, Pain, Back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- St. Ambrose University
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 26 Oct 2018 (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.
To determine if Pain Neuroscience Education (PNE) would result in positive clinical changes in patients presenting with acute or sub-acute low back pain (LBP).
Detailed description
Background: Pain neuroscience education (PNE) has shown efficacy in treating chronic pain. Clinicians may believe PNE is not suitable for acute and sub-acute pain. Subgroupings of low back pain (LBP) imply some patients with LBP may respond favorably to PNE.
Objective: To determine if PNE would result in positive clinical changes in patients presenting with acute or sub-acute LBP.
Methods: Eighty consecutive patients with LBP < 3 months were enrolled in the study. Patients completed a demographics questionnaire, leg and LBP rating (Numeric Pain Rating Scale - NPRS), disability (Oswestry Disability Index), fear-avoidance (Fear-Avoidance Beliefs Questionnaire), pain catastrophization (Pain Catastrophization Scale), central sensitization (Central Sensitization Inventory), pain knowledge (Revised Neurophysiology of Pain Questionnaire), risk assessment (Keele STarT Back Screening Tool), active trunk flexion and straight leg raise (SLR). Patients received a 15-minute verbal, one-on-one PNE session, followed by repeat measurement of LBP and leg pain (NPRS), trunk flexion and SLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational cohort
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education | Experimental | Behavioral: Pain Neuroscience EducationSubjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a complaint of LBP with or without leg pain less than 3 months, and
- a willingness to participate
Key exclusion criteria (6 listed)
- a) were under age 18 (minor);
- b) had undergone lumbar surgery;
- c) could not read or understand the English language;
- d) presented with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.),
- e) declined to participate or
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 |
|---|---|---|
| Pain Neuroscience Education15 minute verbal one-on-one education session | Behavioural | Pain Neuroscience Education |
Primary outcome
NPRS - LBP
Time frame: Immediate change from baseline after assigned intervention
Numeric Pain Rating Scale for Low Back Pain (Range 0 = no pain to 11 = maximum pain)
NPRS - Leg pain
Time frame: Immediate change from baseline after assigned intervention
Numeric Pain Rating Scale for leg pain (Range 0 = no pain to 11 = maximum pain)
2 secondary outcomes
Active trunk flexion
Time frame: Immediate change from baseline in centimeters after assigned intervention
Passive Straight Leg Raise
Time frame: Immediate change from baseline in angular degrees after assigned intervention
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 26 Oct 2018.
- 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, PhD 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 Pain Neuroscience Education in people with Low Back Pain and Pain, Chronic, run by University of Nevada, Las Vegas 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 2 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 26 Oct 2018. 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?
NPRS - LBP (time frame: Immediate change from baseline after assigned intervention). The study lists 2 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 26 Oct 2018.