An interventional study of Aerobic exercise program in Chronic Low Back Pain, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
By doing this study, researchers hope to learn effects of aerobic exercise on over activated nervous system in people with chronic low back pain.
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.
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
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Exclusion Criteria:
Participants will complete 12 week exercise program.
Behavioral: Aerobic exercise program
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.
Pain sensitivity (Pressure pain threshold)
Sensitivity will be measured using a pressure algometer.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Pain Sensitivity (CPM test)
Measure of the functionality of descending inhibitory pain pathways with use of pressure algometry.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Plan to share: No
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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