Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain

October 24, 2018 updated by: Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas

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).

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nevada
      • Las Vegas, Nevada, United States, 89178
        • University of Nevada Las Vegas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kevin Farrell, PhD, St. Ambrose University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1202-4022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Pain Neuroscience Education

Subscribe