NCT03722394

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 22, 2018

Last Update Submit

October 24, 2018

Conditions

Low Back PainPain, ChronicPain, Back

Outcome Measures

Primary Outcomes (2)

  • NPRS - LBP

    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

    Numeric Pain Rating Scale for leg pain (Range 0 = no pain to 11 = maximum pain)

    Immediate change from baseline after assigned intervention

Secondary Outcomes (2)

  • Active trunk flexion

    Immediate change from baseline in centimeters after assigned intervention

  • Passive Straight Leg Raise

    Immediate change from baseline in angular degrees after assigned intervention

Study Arms (1)

Pain Neuroscience Education

EXPERIMENTAL

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

Behavioral: Pain Neuroscience Education

Interventions

Pain Neuroscience EducationBEHAVIORAL

15 minute verbal one-on-one education session

Pain Neuroscience Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a complaint of LBP with or without leg pain less than 3 months, and
  • a willingness to participate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89178, United States

Location

MeSH Terms

Conditions

Low Back PainChronic PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Farrell, PhD

    St. Ambrose University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Observational cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Coordinator

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 26, 2018

Study Start

January 10, 2018

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)