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

• Sponsor: University of Nevada, Las Vegas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03722394
• Collaborator: St. Ambrose University (Other)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 12.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Pain, Chronic; Pain, Back	Behavioral: Pain Neuroscience Education	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Observational cohortObservational cohort
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series
• Actual Study Start Date: Jan 10, 2018
• Actual Primary Completion Date: Jul 30, 2018
• Actual Study Completion Date: Jul 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pain Neuroscience Education Subjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session	Behavioral: Pain Neuroscience Education; 15 minute verbal one-on-one education session

Outcome Measures

Primary Outcome Measures

1. NPRS - LBP [Immediate change from baseline after assigned intervention]

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

2. NPRS - Leg pain [Immediate change from baseline after assigned intervention]

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

Secondary Outcome Measures

1. Active trunk flexion [Immediate change from baseline in centimeters after assigned intervention]

   Active trunk flexion measured in centimeters from fingertips to floor

2. Passive Straight Leg Raise [Immediate change from baseline in angular degrees after assigned intervention]

   Range of hip flexion angle during passive straight leg raise test measured in degrees

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• a willingness to participate

Exclusion Criteria:

• 1. were under age 18 (minor);
• 1. had undergone lumbar surgery;
• 1. could not read or understand the English language;
• 1. presented with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.),
• 1. declined to participate or
• 1. presented with a medical etiology (red flag) associated with their LBP.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada Las Vegas	Las Vegas	Nevada	United States	89178

Sponsors and Collaborators

• University of Nevada, Las Vegas
• St. Ambrose University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emilio J Puentedura, PT, DPT, PhD, Project Coordinator, University of Nevada, Las Vegas
• ClinicalTrials.gov Identifier: NCT03722394
• Other Study ID Numbers: 1202-4022
• First Posted: Oct 26, 2018
• Last Update Posted: Oct 26, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Chronic Pain

Study Results

No Results Posted as of Oct 26, 2018