Central Mechanisms of Intervention for Low Back Pain
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Purpose
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 (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain |
- Immediate change in temporal sensory summation [ Time Frame: 10 minutes post-intervention ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention
- Change in Physical Impairment Index [ Time Frame: 48 hours post-intervention ] [ Designated as safety issue: No ]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: | March 2016 |
| Estimated Primary Completion Date: | February 2016 (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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| 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| Contact: Maggie E Horn, DPT | 352-2735276 | mhorn21@phhp.ufl.edu |
| Contact: Mark D Bishop, PhD | 352-2736112 | bish@ufl.edu |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610-0154 | |
| Principal Investigator: Mark D Bishop, PhD | |
| Sub-Investigator: Jason G Craggs, PhD | |
| Principal Investigator: | Mark D Bishop, PhD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01406847 History of Changes |
| Other Study ID Numbers: | 439-2010, 1R01AT006334-01 |
| Study First Received: | July 26, 2011 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Florida:
|
Spinal Manipulation Body-based intervention Experimental pain |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013