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

Low Back Pain Clinical Trial

Official title:

Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722394
• Other study ID #: 1202-4022
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: October 2018
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Pain, Back
• Pain, Chronic

Intervention

Behavioral:
• Pain Neuroscience Education
15 minute verbal one-on-one education session

Locations

Country	Name	City	State
United States	University of Nevada Las Vegas	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas	St. Ambrose University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Active trunk flexion	Active trunk flexion measured in centimeters from fingertips to floor	Immediate change from baseline in centimeters after assigned intervention
Secondary	Passive Straight Leg Raise	Range of hip flexion angle during passive straight leg raise test measured in degrees	Immediate change from baseline in angular degrees after assigned intervention