Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

University of Florida

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Spinal manipulation; Behavioral: Physical Impairment; Procedure: fMRI; Procedure: Therapeutic touch; Other: Questionnaires; Behavioral: Pain Sensitivity Testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02375386

3R01AT006334-02S1 (U.S. NIH Grant/Contract)

IRB201300827-N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Spinal manipulation

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Sensitivity Testing

Procedure: Spinal manipulation

Procedure: fMRI

Behavioral: Physical Impairment

Other: Questionnaires

Therapeutic touch

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Pain Sensitivity Testing

Procedure: fMRI

Procedure: Therapeutic touch

Behavioral: Physical Impairment

Other: Questionnaires