Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

CENTRAL MECHANISMS OF BODY BASED INTERVENTION FOR MUSCULOSKELETAL LOW BACK PAIN: Feasibility Assessment of Neurophysiological Measurement in Veterans With Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Spinal manipulation; Procedure: fMRI; Behavioral: Pain Sensitivity Testing; Other: Questionnaires; Behavioral: Physical Impairment; Procedure: Therapeutic touch

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-0154
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal manipulation; Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.	Procedure: Spinal manipulation; Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.; Procedure: fMRI; Both groups will receive an fMRI.; Other Names: Functional MRI; Behavioral: Pain Sensitivity Testing; Both groups will receive an Pain Sensitivity Testing; Other: Questionnaires; Both groups will receive Questionnaires; Behavioral: Physical Impairment; Both groups will receive testing on physical impairment.
Sham Comparator: Therapeutic touch; Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.	Procedure: fMRI; Both groups will receive an fMRI.; Other Names: Functional MRI; Behavioral: Pain Sensitivity Testing; Both groups will receive an Pain Sensitivity Testing; Other: Questionnaires; Both groups will receive Questionnaires; Behavioral: Physical Impairment; Both groups will receive testing on physical impairment.; Procedure: Therapeutic touch; Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Change from Day 3, Day 4 and Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	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.	Change from Day 3, Day 4 and Day 5
McGill Pain Questionnaire-2	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.	Change from Day 3, Day 4 and Day 5
Physical Impairment	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.	Change from Day 3, Day 4 and Day 5
Oswestry Disability Questionnaire (ODQ)	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.	Change from Day 3, Day 4 and Day 5

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Mark D Bishop, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB201300827-N; 3R01AT006334-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO