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Completed

NCT Number: NCT03546153

Examining Effects of Aerobic Exercise on Pain Sensation

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

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Key information

Conditions

Chronic Low Back Pain

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise Program

Behavioral

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.

Primary outcomes

  1. Pain sensitivity (Pressure pain threshold)

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Sensitivity will be measured using a pressure algometer.

  2. 2011 FM survey

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    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.

  3. Opioid consumption

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Use of opioids (dose, frequency, and duration) will be obtained by interviewing the subjects

  4. Oswestry Disability Index

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    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.

Secondary outcomes

  1. Pain Sensitivity (CPM test)

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Measure of the functionality of descending inhibitory pain pathways with use of pressure algometry.

  2. Fear Avoidance Belief Questionnaire

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    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.

  3. Pain Catastrophizing Scale

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    PCS is a validated 13--item scale with questions related to catastrophizing behavior. Total score is 52 with higher scores indicating greater catastrophic thoughts.

  4. Beck Depression Inventory

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Beck depression questionnaire contains 21 multiple-choice depression related questions on a scale value of 0 to 3. Higher scores indicate greater depressive symptoms.

  5. Beck Anxiety Inventory

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Beck anxiety questionnaire contains 21 multiple-choice questions, each score 0 (not al all) to 3 (severely). Higher scores indicate greater anxiety symptoms.

  6. Pittsburgh Sleep Quality Index

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Pittsburgh sleep quality index contains 19 questions, creating 7 components that produce one global score. Higher scores indicate poorer sleep quality.

  7. Lumbar spine range of motion

    Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

    Lumbar spine range of motion into forward, backward, and side bending will be assessed with two inclinometers or a tape measure. subjects will

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Phenotyping Chronic Low Back Pain Patients With Central Sensitization

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2018
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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