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

July 26, 2011
April 16, 2014
August 2012
February 2016   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01406847 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Central Mechanisms of Intervention for Low Back Pain
Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Low Back Pain
  • Other: Spinal Manipulation
    High velocity low amplitude joint-biased intervention
    Other Name: SMT
  • Other: Spinal Mobilization
    Low velocity, large amplitude oscillating joint biased technique
    Other Names:
    • Mobilization
    • Mobs
  • Other: Static Touch
    The investigators maintains hand contact with both hands over the lumbar area of the participant
  • Experimental: Spinal Manipulation
    High-velocity manual technique applied to the pelvis with the participant in supine
    Intervention: Other: Spinal Manipulation
  • Sham Comparator: Static Touch
    Practitioner hands are placed on the lumbar spine with the participant in prone.
    Intervention: Other: Static Touch
  • Active Comparator: Spinal Mobilization
    Oscillation of the third lumbar level performed with the participant in prone
    Intervention: Other: Spinal Mobilization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
March 2016
February 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact: Cally House 352-2735276 CALLY.HOUSE@PHHP.UFL.EDU
Contact: Mark D Bishop, PhD 352-2736112 bish@ufl.edu
United States
 
NCT01406847
439-2010, 1R01AT006334-01
Yes
University of Florida
University of Florida
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Mark D Bishop, PhD University of Florida
University of Florida
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP