Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

NCT02375386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-02-15

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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

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.

PROCEDURE

fMRI

Both groups will receive an fMRI.

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • University of Florida

    lead OTHER

Principal Investigators

  • Mark D Bishop, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-05-01
Completion
2017-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375386 on ClinicalTrials.gov