Central Mechanisms of Intervention for Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01406847
First received: July 26, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.


Condition Intervention
Low Back Pain
Other: Spinal Manipulation
Other: Spinal Mobilization
Other: Static Touch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Immediate change in temporal sensory summation [ Time Frame: 10 minutes post-intervention ] [ Designated as safety issue: No ]
    We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.

  • Change in temporal sensory summation [ Time Frame: 48 hours post-intervention ] [ Designated as safety issue: No ]
    The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention


Secondary Outcome Measures:
  • Change in Physical Impairment Index [ Time Frame: 48 hours post-intervention ] [ Designated as safety issue: No ]
    Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance


Estimated Enrollment: 170
Study Start Date: August 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal Manipulation
High-velocity manual technique applied to the pelvis with the participant in supine
Other: Spinal Manipulation
High velocity low amplitude joint-biased intervention
Other Name: SMT
Sham Comparator: Static Touch
Practitioner hands are placed on the lumbar spine with the participant in prone.
Other: Static Touch
The investigators maintains hand contact with both hands over the lumbar area of the participant
Active Comparator: Spinal Mobilization
Oscillation of the third lumbar level performed with the participant in prone
Other: Spinal Mobilization
Low velocity, large amplitude oscillating joint biased technique
Other Names:
  • Mobilization
  • Mobs

Detailed Description:

170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18 to 40 years
  • able to read and understand spoken English

Exclusion Criteria:

  • Previous participation in a conditioning program specific to trunk extensors in the past 6 months
  • Any report of back or leg pain in the past 3 months
  • Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder
  • History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction
  • Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation
  • Performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol
  • Recent illness
  • Any contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406847

Contacts
Contact: Cally House 352-2735276 CALLY.HOUSE@PHHP.UFL.EDU
Contact: Mark D Bishop, PhD 352-2736112 bish@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610-0154
Principal Investigator: Mark D Bishop, PhD         
Sub-Investigator: Jason G Craggs, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Mark D Bishop, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01406847     History of Changes
Other Study ID Numbers: 439-2010, 1R01AT006334-01
Study First Received: July 26, 2011
Last Updated: April 16, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Florida:
Spinal Manipulation
Body-based intervention
Experimental pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014