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Central Mechanisms of Intervention for Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University of Florida
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Florida Identifier:
First received: July 26, 2011
Last updated: December 21, 2016
Last verified: December 2016
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 (Participant, 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 ]
    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 ]
    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 ]
    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: June 2017
Estimated Primary Completion Date: June 2017 (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.

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.
  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 identifier: NCT01406847

Contact: Mark D Bishop, PT, PhD 352-273-6112

United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610-0154
Principal Investigator: Mark D Bishop, PhD         
Sub-Investigator: Steven Z George, PhD         
Sub-Investigator: Michael E Robinsons, PhD         
Sponsors and Collaborators
University of Florida
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Mark D Bishop, PT, PhD University of Florida
  More Information

Responsible Party: University of Florida Identifier: NCT01406847     History of Changes
Other Study ID Numbers: IRB201602462
1R01AT006334-01 ( US NIH Grant/Contract Award Number )
439-2010 ( Other Identifier: UF legacy )
Study First Received: July 26, 2011
Last Updated: December 21, 2016

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 28, 2017