Examining Effects of Aerobic Exercise on Pain Sensation

Study Overview
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Brief Summary
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By doing this study, researchers hope to learn effects of aerobic exercise on over activated nervous system in people with chronic low back pain.

Detailed Description
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Chronic low back pain is a common condition in the world. About 85% of people with low back pain do not know the cause of their pain. This leads to ineffective treatments. Recently, the idea of an over activated nervous system is thought to be one of the main reasons for chronic pain. Over activated nervous system means pain processing areas in the spine or brain might be more sensitive. Aerobic exercise, such as walking and cycling, is often used to decrease chronic pain. Aerobic exercise is a form of physical exercise that strengthen the heart and lungs in order to improve the body's utilization of oxygen. The researchers want to examine if aerobic exercise is effective in decreasing over activation of the nervous system. Gaining a better understanding of effects of aerobic exercise on the nervous system may lead to more effective treatments for low back pain.

Official Title
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Phenotyping Chronic Low Back Pain Patients With Central Sensitization

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Aerobic exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lower back pain (LBP) for more than 3 months A minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days Can read and understand English. Exclusion Criteria: Nerve root compression that resulted in numbness or decrease in sensation in the areas for the pain sensitivity tests as reported by the subject cervical or thoracic pain as a main complaint spinal pathologies such as fracture, tumor, infection, and severe inflammation severe spinal deformity severe cardiovascular and neurological diseases cancer history of spinal surgery currently seeking active treatments for LBP other than medications resting blood pressure more than 160/90 mmHg 49 currently taking blood thinning medications uncontrolled diabetes cannot have blood pressure taken participated in a similar trial in the past

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise program<br>Participants will complete 12 week exercise program. | Behavioral: Aerobic exercise program<br>* Exercise program consists of training for 60 minutes, three times per week for 12 weeks. Participants will use a treadmill, Nu stepper/bike or elliptical to exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity (Pressure pain threshold) | Sensitivity will be measured using a pressure algometer. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| 2011 FM survey | Sensitivity will be measured using the 2011 Fibromyalgia (FM) Survey Criteria. The survey includes widespread pain index and symptom severity scale. The total score is 31 and scores more than 13 is considered fibromyalgia positive, suggesting presence of central sensitization. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Opioid consumption | Use of opioids (dose, frequency, and duration) will be obtained by interviewing the subjects | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Oswestry Disability Index | This questionnaire consists of questions related to daily functions and degrees to which back pain interferes with these functions. Each items is measured on a 6-point scale with a total possible score of 50. Higher numbers indicate greater disability. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Sensitivity (CPM test) | Measure of the functionality of descending inhibitory pain pathways with use of pressure algometry. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Fear Avoidance Belief Questionnaire | The survey has items related to fear about physical and work activities. Each item is scored from 0-6 points, with higher number indicating increased fear of activity or work. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Pain Catastrophizing Scale | PCS is a validated 13--item scale with questions related to catastrophizing behavior. Total score is 52 with higher scores indicating greater catastrophic thoughts. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Beck Depression Inventory | Beck depression questionnaire contains 21 multiple-choice depression related questions on a scale value of 0 to 3. Higher scores indicate greater depressive symptoms. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Beck Anxiety Inventory | Beck anxiety questionnaire contains 21 multiple-choice questions, each score 0 (not al all) to 3 (severely). Higher scores indicate greater anxiety symptoms. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Pittsburgh Sleep Quality Index | Pittsburgh sleep quality index contains 19 questions, creating 7 components that produce one global score. Higher scores indicate poorer sleep quality. | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) | 
| Lumbar spine range of motion | Lumbar spine range of motion into forward, backward, and side bending will be assessed with two inclinometers or a tape measure. subjects will | Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment) |