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

Primary Purpose

Low Back Pain, Pain, Chronic, Pain, Back

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Neuroscience Education
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nevada Las Vegas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain Neuroscience Education

Arm Description

Subjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session

Outcomes

Primary Outcome Measures

NPRS - LBP
Numeric Pain Rating Scale for Low Back Pain (Range 0 = no pain to 11 = maximum pain)
NPRS - Leg pain
Numeric Pain Rating Scale for leg pain (Range 0 = no pain to 11 = maximum pain)

Secondary Outcome Measures

Active trunk flexion
Active trunk flexion measured in centimeters from fingertips to floor
Passive Straight Leg Raise
Range of hip flexion angle during passive straight leg raise test measured in degrees

Full Information

First Posted
October 22, 2018
Last Updated
October 24, 2018
Sponsor
University of Nevada, Las Vegas
Collaborators
St. Ambrose University
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1. Study Identification

Unique Protocol Identification Number
NCT03722394
Brief Title
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain
Official Title
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
St. Ambrose University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Pain, Chronic, Pain, Back

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Observational cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education
Arm Type
Experimental
Arm Description
Subjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session
Intervention Type
Behavioral
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
15 minute verbal one-on-one education session
Primary Outcome Measure Information:
Title
NPRS - LBP
Description
Numeric Pain Rating Scale for Low Back Pain (Range 0 = no pain to 11 = maximum pain)
Time Frame
Immediate change from baseline after assigned intervention
Title
NPRS - Leg pain
Description
Numeric Pain Rating Scale for leg pain (Range 0 = no pain to 11 = maximum pain)
Time Frame
Immediate change from baseline after assigned intervention
Secondary Outcome Measure Information:
Title
Active trunk flexion
Description
Active trunk flexion measured in centimeters from fingertips to floor
Time Frame
Immediate change from baseline in centimeters after assigned intervention
Title
Passive Straight Leg Raise
Description
Range of hip flexion angle during passive straight leg raise test measured in degrees
Time Frame
Immediate change from baseline in angular degrees after assigned intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Farrell, PhD
Organizational Affiliation
St. Ambrose University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89178
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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