Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT02375386
• Lead Sponsor: University of Florida

Brief Summary

This is study testing the feasibility of collecting neurophysiological measures of outcome related to body-based interventions for low back pain. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the interventions. Participants will be randomly assigned to either spinal manipulation or therapeutic touch groups. Participants will attend two practice sessions prior to the first data collection. There will be two follow-up assessments.

Detailed Description

Participants will be enrolled from VA pain clinical at the North Florida/South George VA Medical Center.

The investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using thermal and mechanical stimuli. These data will be collected before and after the interventions, in addition to two follow-up sessions after intervention.

In addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• complaints of current back pain that they rate at least 40 on a 101-point numeric rating scale
• Participants must able to understand written and spoken English

Exclusion Criteria

• currently receiving treatment for LBP or have received SMT for LBP in the past year
• Quebec Task Force on Spinal Disorders (QTFSD) to identify patients with pre-existing nerve root compression, spinal stenosis, or post-surgery
• any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches)
• any contraindication to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fMRI during testing of pain changes from approximately Day 3 and Day 5	Change from approximately Day 3 and Day 5
fMRI during quite rest changes from approximately Day 3 and Day 5	Change from approximately Day 3 and Day 5
Pain Sensitivity Testing changes from Day 3, Day 4 and Day 5	Change from Day 3, Day 4 and Day 5	This measure thermal threshold and tolerance using continuous heat stimulus delivered to the participants' dominant arm. The stimulus will start at 35°C and will be increased at a rate of 0.5°C with participants terminating the stimulus when the temperature reached pain threshold ("when the sensation first transitions from heat to pain") and tolerance ("when the sensation becomes so strong you want to remove it from your skin"). Threshold and tolerance measures will also be collected using mechanical pressure applied using a Fischer Dolorimeter. During Dolorimeter testing, force is slowly increased until the subject indicates that the sensation changes from pressure to pain.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Questionnaire (ODQ)	Change from Day 3, Day 4 and Day 5	The ODQ has a range of 0 (no disability due to back pain) to 100 (completely disabled due to back pain), so higher scores indicate higher disability from LBP.
Pain Intensity	Change from Day 3, Day 4 and Day 5	Pain visual analog scale is a 10cm long line. The line is anchored at one end with 'none' or 'not bad at all' and at the other with 'worst imaginable.' Participants are asked to rate their pain at rest by placing a mark along the 10cm line. Participants will also rate pain during active trunk range of motion using the same scale.
McGill Pain Questionnaire-2	Change from Day 3, Day 4 and Day 5	This is 22-item questionnaire that asks participants to describe the intensity of varies qualities of the pain that he or she is experiencing; for example, throbbing or itching.
Physical Impairment	Change from Day 3, Day 4 and Day 5	A physical impairment scale consists of 7 different examination procedures that assess lumbar and hip range of motion, muscle performance of trunk musculature, and response to palpation. Scores is 0 - 8, Range is 0 is no impairment and 8 is completely impaired.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States