Examining Effects of Aerobic Exercise on Pain Sensation

Chronic Low Back Pain Clinical Trial

Official title:

Phenotyping Chronic Low Back Pain Patients With Central Sensitization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546153
• Other study ID #: STUDY00141062
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)