Clinical trial NCT03546153: Examining Effects of Aerobic Exercise on Pain Sensation
Official title: Phenotyping Chronic Low Back Pain Patients With Central Sensitization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain sensitivity (Pressure pain threshold)
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: 2011 FM survey
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Opioid consumption
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Oswestry Disability Index
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Secondary outcomes:
measure: Pain Sensitivity (CPM test)
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Fear Avoidance Belief Questionnaire
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Pain Catastrophizing Scale
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Beck Depression Inventory
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Beck Anxiety Inventory
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
measure: Lumbar spine range of motion
timeFrame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Neena Sharma, PT, PhD, CMPT
role: PRINCIPAL_INVESTIGATOR
References: