Central Mechanisms of Intervention for Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Spinal Manipulation; Other: Static Touch; Other: Spinal Mobilization

• Registration Number: NCT01406847
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Study Start: 2012-08
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Manipulation	Spinal Manipulation	High-velocity manual technique applied to the pelvis with the participant in supine
Static Touch	Static Touch	Practitioner hands are placed on the lumbar spine with the participant in prone.
Spinal Mobilization	Spinal Mobilization	Oscillation of the third lumbar level performed with the participant in prone

Primary Outcome Measures

Name	Time	Method
Change in temporal sensory summation	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
Immediate change in temporal sensory summation	10 minutes post-intervention	We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.

Secondary Outcome Measures

Name	Time	Method
Change in Physical Impairment Index	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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States