Chronic Low Back PainNCT03546153
Examining Effects of Aerobic Exercise on Pain Sensation
A study testing Aerobic exercise program in people with Chronic Low Back Pain, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Aerobic exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Phenotyping Chronic Low Back Pain Patients With Central Sensitization
By doing this study, researchers hope to learn effects of aerobic exercise on over activated nervous system in people with chronic low back pain.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Aerobic exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise program | Experimental | Participants will complete 12 week exercise program. Receives: Behavioral: Aerobic exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity (Pressure pain threshold)
Sensitivity will be measured using a pressure algometer.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Secondary outcomes (7)
Pain Sensitivity (CPM test)
Measure of the functionality of descending inhibitory pain pathways with use of pressure algometry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jun 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neena Sharma, PT, PhD, CMPT, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546153
- Sponsor's protocol ID
- STUDY00141062
- Status last verified
- Sep 2019
- First submitted
- 22 May 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Chronic Low Back Pain Patients With Central Sensitization
- ClinicalTrials.gov ID
- NCT03546153
- Acronym / sponsor ID
- STUDY00141062
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise program | Experimental | Behavioral: Aerobic exercise programParticipants will complete 12 week exercise program. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise programExercise 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. | Behavioural | Aerobic exercise program |
Primary outcome
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.
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.
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
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.
7 secondary outcomes
Pain Sensitivity (CPM test)
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Fear Avoidance Belief Questionnaire
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Pain Catastrophizing Scale
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Beck Depression Inventory
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Beck Anxiety Inventory
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Pittsburgh Sleep Quality Index
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Lumbar spine range of motion
Time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neena Sharma, PT, PhD, CMPT principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise program in people with Chronic Low Back Pain, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensitivity (Pressure pain threshold) (time frame: Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.