Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

NCT02375386 | Completed DMC

• 2 other identifiers: IRB201300827-N3R01AT006334-02S1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Pain Intensity

  Change from Day 3, Day 4 and Day 5

• McGill Pain Questionnaire-2

  Change from Day 3, Day 4 and Day 5

• Physical Impairment

  Change from Day 3, Day 4 and Day 5

• Oswestry Disability Questionnaire (ODQ)

  Change from Day 3, Day 4 and Day 5

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

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; Procedure: fMRI; Behavioral: Pain Sensitivity Testing; Other: Questionnaires; Behavioral: Physical Impairment

Therapeutic touch

SHAM COMPARATOR

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

Interventions

Spinal manipulation PROCEDURE

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.

Spinal manipulation

Therapeutic touch PROCEDURE

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.

Therapeutic touch

fMRI PROCEDURE

Both groups will receive an fMRI.

Also known as: Functional MRI

Spinal manipulation; Therapeutic touch

Pain Sensitivity Testing BEHAVIORAL

Both groups will receive an Pain Sensitivity Testing

Spinal manipulation; Therapeutic touch

Questionnaires OTHER

Both groups will receive Questionnaires

Spinal manipulation; Therapeutic touch

Physical Impairment BEHAVIORAL

Both groups will receive testing on physical impairment.

Spinal manipulation; Therapeutic touch

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610-0154, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal; Therapeutic Touch; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mark D Bishop, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)