- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722394
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89178
- University of Nevada Las Vegas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a complaint of LBP with or without leg pain less than 3 months, and
- a willingness to participate
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain Neuroscience Education
Subjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session
|
15 minute verbal one-on-one education session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Immediate change from baseline after assigned intervention
|
|
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)
|
Immediate change from baseline after assigned intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active trunk flexion
Time Frame: Immediate change from baseline in centimeters after assigned intervention
|
Active trunk flexion measured in centimeters from fingertips to floor
|
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
|
Range of hip flexion angle during passive straight leg raise test measured in degrees
|
Immediate change from baseline in angular degrees after assigned intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Farrell, PhD, St. Ambrose University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1202-4022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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