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Central Mechanisms of Intervention for Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406847
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : April 5, 2018
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Other: Spinal Manipulation Other: Spinal Mobilization Other: Static Touch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain
Study Start Date : August 2012
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Immediate change in temporal sensory summation [ Time Frame: 10 minutes post-intervention ]
    We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.

  2. Change in temporal sensory summation [ Time Frame: 48 hours post-intervention ]
    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 :
  1. Change in Physical Impairment Index [ Time Frame: 48 hours post-intervention ]
    Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406847

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0154
Sponsors and Collaborators
University of Florida
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Mark D Bishop, PT, PhD University of Florida
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Responsible Party: University of Florida Identifier: NCT01406847    
Other Study ID Numbers: IRB201602462-N
1R01AT006334-01 ( U.S. NIH Grant/Contract )
439-2010 ( Other Identifier: UF legacy )
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Keywords provided by University of Florida:
Spinal Manipulation
Body-based intervention
Experimental pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms