Clinical trial NCT02375386: Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP
Official title: CENTRAL MECHANISMS OF BODY BASED INTERVENTION FOR MUSCULOSKELETAL LOW BACK PAIN: Feasibility Assessment of Neurophysiological Measurement in Veterans With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-03-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: fMRI during testing of pain changes from approximately Day 3 and Day 5
timeFrame: Change from approximately Day 3 and Day 5
measure: fMRI during quite rest changes from approximately Day 3 and Day 5
timeFrame: Change from approximately Day 3 and Day 5
measure: Pain Sensitivity Testing changes from Day 3, Day 4 and Day 5
timeFrame: Change from Day 3, Day 4 and Day 5
Secondary outcomes:
measure: Pain Intensity
timeFrame: Change from Day 3, Day 4 and Day 5
measure: McGill Pain Questionnaire-2
timeFrame: Change from Day 3, Day 4 and Day 5
measure: Physical Impairment
timeFrame: Change from Day 3, Day 4 and Day 5
measure: Oswestry Disability Questionnaire (ODQ)
timeFrame: Change from Day 3, Day 4 and Day 5
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Mark D Bishop, PhD
role: PRINCIPAL_INVESTIGATOR
References: