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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Spinal Manipulation; Other: Static Touch; Other: Spinal Mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-0154
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate change in temporal sensory summation	We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.	10 minutes post-intervention
Change in temporal sensory summation	The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention	48 hours post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Impairment Index	Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance	48 hours post-intervention

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Mark D Bishop, PT, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Spinal Manipulation; Experimental pain; Body-based intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB201602462-N; 1R01AT006334-01 (U.S. NIH Grant/Contract); 439-2010 (Other Identifier: UF legacy)