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Examining Effects of Aerobic Exercise on Pain Sensation

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise program
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aerobic exercise program

Arm Description

Participants will complete 12 week exercise program.

Outcomes

Primary Outcome Measures

Pain sensitivity (Pressure pain threshold)
Sensitivity will be measured using a pressure algometer.
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.
Opioid consumption
Use of opioids (dose, frequency, and duration) will be obtained by interviewing the subjects
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.

Secondary Outcome Measures

Pain Sensitivity (CPM test)
Measure of the functionality of descending inhibitory pain pathways with use of pressure algometry.
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.
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.
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.
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.
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.
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

Full Information

First Posted
May 22, 2018
Last Updated
September 26, 2019
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03546153
Brief Title
Examining Effects of Aerobic Exercise on Pain Sensation
Official Title
Phenotyping Chronic Low Back Pain Patients With Central Sensitization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise program
Arm Type
Experimental
Arm Description
Participants will complete 12 week exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise program
Intervention Description
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 Outcome Measure Information:
Title
Pain sensitivity (Pressure pain threshold)
Description
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)
Title
2011 FM survey
Description
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)
Title
Opioid consumption
Description
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)
Title
Oswestry Disability Index
Description
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)
Secondary Outcome Measure Information:
Title
Pain Sensitivity (CPM test)
Description
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)
Title
Fear Avoidance Belief Questionnaire
Description
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)
Title
Pain Catastrophizing Scale
Description
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)
Title
Beck Depression Inventory
Description
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)
Title
Beck Anxiety Inventory
Description
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)
Title
Pittsburgh Sleep Quality Index
Description
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)
Title
Lumbar spine range of motion
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neena Sharma, PT, PhD, CMPT
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Examining Effects of Aerobic Exercise on Pain Sensation

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