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NCT Number: NCT01406847

Central Mechanisms of Intervention for 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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610-0154, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal Manipulation

Other

High velocity low amplitude joint-biased intervention

Other names: SMT

Spinal mobilization

Other

Low velocity, large amplitude oscillating joint biased technique

Other names: Mobilization, Mobs

Static Touch

Other

The investigators maintains hand contact with both hands over the lumbar area of the participant

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2011
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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