Chronic Low-back PainSUMITNCT04257539
Reducing Sedentary Time in Chronic Low Back Pain: Sedentary Intervention Using Motivational Interviewing and Technology
A study testing Intervention to Reduce Sedentary Time in people with Chronic Low-back Pain, run by Iowa State University at 1 site in United States.
Trial summary
This study will test the effects of a sedentary behavior intervention on pain processing, blood bio-markers and pain symptoms in individuals with chronic low back pain. The behavioral intervention will include a wrist-worn activity monitor that will notify participants when they have been sedentary for too long… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Intervention to Reduce Sedentary Time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 6 Apr 2020
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic low back pain (Currently experiencing low back pain every day or nearly every day for longer than 3 months)
- Elevated depressive symptoms (Patient Health Questionnaire-9 greater than or equal to 5)
- Ability to safely complete exercise session (Physical Activity Readiness Questionnaire)
- Willing to wear a physical activity tracker with an idle alert
- Regular access to computer or smartphone
Who cannot join
- Currently using activity tracker with idle alert
- Taking immunomodulatory medication
- Taking anti-depressant medication
- Changed medication or treatment in last 8 weeks
- Have injuries or conditions that prevent change in activity level
- Pregnant or planning to become pregnant during study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Reducing Sedentary Behavior on Symptoms, Inflammation and Endocannabinoids in Patients With Chronic Low Back Pain and Elevated Depressive Symptoms
This study will test the effects of a sedentary behavior intervention on pain processing, blood bio-markers and pain symptoms in individuals with chronic low back pain. The behavioral intervention will include a wrist-worn activity monitor that will notify participants when they have been sedentary for too long, motivational interviewing, and habit development.
Read the detailed description
Chronic low back pain (cLBP) is a prevalent and costly condition that is associated with substantial individual and societal burden. Exercise is a recommended behavioral treatment but adherence to regular exercise is frequently low in individuals with cLBP, so research of the utility of other behavioral treatments is needed. Previous research suggests that reducing sitting time (or sedentary time) may improve symptoms of back pain and be beneficial in treating chronic low back pain. Thus, the purpose of this study is to examine the utility of a theory-based intervention to reduce sedentary time (Sedentary-intervention Utilizing Motivational Interviewing and Technology, or 'SUMIT') in individuals with cLBP. Specifically, the primary aim of this study is to examine the utility of SUMIT on sedentary behaviors in individuals with cLBP and elevated symptoms of depression. Secondary aims are to determine how SUMIT influences mood, pain symptoms, and pain psychophysics, and to quantify cytokine and endocannabinoid responses to acute exercise across the intervention. To test this, individuals with cLBP will either be randomized into an intervention group (n=20) or a wait-list control group (n=20). Additionally, healthy adults (n=20) without cLBP will be enrolled to serve as a pain-free control group and will not receive the intervention. All participants will complete baseline assessments, enroll in an 8-week intervention period, return for final assessments and a 3-month follow up. Over the intervention period, those in the intervention group will be provided with a wrist-worn activity monitor that vibrates after prolonged sedentariness and a behavioral intervention utilizing motivational interviewing and education surrounding sitting habits and strategies for new habit development. Individuals in the cLBP wait-list control group and pain-free control group will be asked to maintain current physical activity levels, sedentary behaviors, and medication and/or treatment for low back pain during this period. The investigators hypothesize that 1) objectively-monitored prolonged sedentary behavior will decrease across SUMIT and be maintained at follow-up, 2) cLBP symptoms, mood-related symptoms, and pain psychophysics (e.g pain regulation and modulation) will improve across SUMIT with maintenance of changes at follow-up, and 3) in response to acute exercise, cytokine and endocannabinoid responses post-SUMIT will become more similar to those of controls. If effective, this scalable intervention could be implemented as a behavioral treatment for cLBP.
- Conditions
- Chronic Low-back Pain
- Being tested
- Intervention to Reduce Sedentary Time
- Keywords
- Sedentary
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to Reduce Sedentary TimeBehavioural
Chronic low back pain participants in the intervention group will be provided with a wrist-worn activity device that vibrates after prolonged sedentariness and meet with a health coach trained in motivational interviewing to discuss individual sedentary levels and provide education surrounding sitting habits and strategies for new habit development. Participants will meet with the health coach initially and at 4 weeks during the 8 week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior. This will include an initial, in-person behavioral intervention with a health coach trained and a 4 week phone call. Participants will receive a wrist-worn activity prompter to aid in sedentary behavior reduction. Receives: Behavioral: Intervention to Reduce Sedentary Time |
| Wait-list Control Group | No intervention | Chronic low back pain participants in this group will not receive the intervention until completion of the study. Over the 8 week intervention period, participants will be asked to maintain currently levels of physical activity, sedentary behaviors, and treatment for low back pain. |
| Pain-free Control Group | No intervention | These subjects will be healthy, pain-free adults and receive no intervention. Over the 8 week intervention period, participants in this group will be asked to maintain currently levels of physical activity, sedentary behaviors, and medication regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline monitor-assessed sedentary time at 8 weeks
Average daily sedentary time in bouts longer than 60 minutes assessed using thigh worn activPAL monitors. The activPAL classifies time into sedentary, upright and stepping, has been validated for measuring free-living sedentary behaviors and is sensitive to changes in these behaviors.
Measured: baseline and immediately following intervention (8 weeks)
Change from baseline depressive symptoms at 8 weeks
The Patient Health Questionnaire (PHQ-9), consisting of 9 questions, will be used for participants to report the presence and severity of depressive symptoms over the past 2 weeks. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: baseline, immediately following intervention (8 weeks), and 3-months after intervention
Change from baseline low back pain symptoms at 8 weeks
The Minimal Dataset for Low Back Pain will be used for participants to report current symptoms of low back pain and impact on daily life. On this questionnaire, for each item a score of 1 is least severe and 5 most severe, with the exception of the single item on pain intensity, which ranges from 0 (no pain) to 10 (worst possible pain). Total scores range from 8 (least impact) to 50 (most impact).
Measured: baseline, immediately following intervention (8 weeks), and 3-months after intervention
Change from baseline pain sensitivity levels at 8 weeks
Pain sensitivity will be asesssed using the Medoc Pathway Pain \& Sensory Evaluation System and applying thermal stimuli to the palm of the non-dominant hand. Subjects will be randomly presented temperatures ranging from 41°to 49°C and asked to rate each stimulus using two separate category-ratio scales to assess pain intensity and unpleasantness.
Measured: before exercise at baseline and immediately following intervention (8 weeks)
Change from baseline pain inhibition at 8 weeks
Exercise-induced hypoalgesia (EIH) will be used to assess pain inhibition. EIH will be tested by re-administering the pain-sensitivity protocol post exercise.
Measured: after exercise at baseline and immediately following intervention (8 weeks)
Change from baseline plasma cytokine levels at 8 weeks
Blood samples will be collected and processed to determine concentrations of IL-6 and TNF-alpha.
Measured: before and after exercise at baseline and immediately following intervention (8 weeks)
Change from baseline plasma endocannabinoid levels at 8 weeks
Blood samples will be collected and processed to determine levels of anandamide(AEA) and 2-arachidonoylglycerol (2-AG).
Measured: before and after exercise at baseline and immediately following intervention (8 weeks)
Secondary outcomes (4)
Change from baseline 36-Item Short Form Survey (SF-36) scores at 8 weeks
SF-36 is a patient health and quality of life questionnaire consisting of 36 questions with the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, so a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: baseline, immediately following intervention, and 3-months after intervention
Change from baseline Profile of Mood States Short Form scores at 8 weeks
This measure asks 36 questions and assesses different dimensions of mood, including: tension, anger, vigor, fatigue, depression, and confusion. Participants rate the extent to which adjectives describe them during the past week using a 1-5 Likert scale. Totals are created for each subscale (Tension, Depression, Anger, Fatigue, Confusion, and Vigor), with higher ratings indicating greater levels of that subscale. Total Mood Disturbance is calculated by adding the first 5 subscales and then subtracting Vigor, with higher scores indicating greater mood disturbance.
Measured: baseline, immediately following intervention, and 3-months after intervention
Change from baseline self-reported sedentary time at 8 weeks
The SIT Q 7d will be used for participants to recall their sedentary time over the past 7 days in different domains, including eating meals, transportation, occupation, screen-time, and other. Participants report levels of sitting in each domain, with higher amounts indicated great total sedentary time.
Measured: baseline, immediately following intervention, and 3-months after intervention
Change from baseline monitor-assessed physical activity at 8 weeks
Average light, moderate and vigorous physical activity per day will be assessed with a thigh-worn activPAL monitor.
Measured: baseline and immediately following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Apr 2018
- Primary completion3 Feb 2020
- Study completion6 Apr 2020
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 40 participants with chronic low back pain were randomized to either Intervention or Wait-list Control groups, while all 20 healthy control participants did not receive the intervention.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Meyer, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257539
- Sponsor's protocol ID
- 18-068
- Acronym
- SUMIT
- Status last verified
- Aug 2020
- First submitted
- 31 Jan 2020
- Last updated
- 10 Aug 2020
- 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 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Reducing Sedentary Behavior on Symptoms, Inflammation and Endocannabinoids in Patients With Chronic Low Back Pain and Elevated Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04257539
- Acronym / sponsor ID
- SUMIT / 18-068
- Conditions
- Chronic Low-back Pain
- Keywords
- Sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 6 Feb 2020 (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.
This study will test the effects of a sedentary behavior intervention on pain processing, blood bio-markers and pain symptoms in individuals with chronic low back pain. The behavioral intervention will include a wrist-worn activity monitor that will notify participants when they have been sedentary for too long, motivational interviewing, and habit development.
Detailed description
Chronic low back pain (cLBP) is a prevalent and costly condition that is associated with substantial individual and societal burden. Exercise is a recommended behavioral treatment but adherence to regular exercise is frequently low in individuals with cLBP, so research of the utility of other behavioral treatments is needed. Previous research suggests that reducing sitting time (or sedentary time) may improve symptoms of back pain and be beneficial in treating chronic low back pain. Thus, the purpose of this study is to examine the utility of a theory-based intervention to reduce sedentary time (Sedentary-intervention Utilizing Motivational Interviewing and Technology, or 'SUMIT') in individuals with cLBP. Specifically, the primary aim of this study is to examine the utility of SUMIT on sedentary behaviors in individuals with cLBP and elevated symptoms of depression. Secondary aims are to determine how SUMIT influences mood, pain symptoms, and pain psychophysics, and to quantify cytokine and endocannabinoid responses to acute exercise across the intervention. To test this, individuals with cLBP will either be randomized into an intervention group (n=20) or a wait-list control group (n=20). Additionally, healthy adults (n=20) without cLBP will be enrolled to serve as a pain-free control group and will not receive the intervention. All participants will complete baseline assessments, enroll in an 8-week intervention period, return for final assessments and a 3-month follow up. Over the intervention period, those in the intervention group will be provided with a wrist-worn activity monitor that vibrates after prolonged sedentariness and a behavioral intervention utilizing motivational interviewing and education surrounding sitting habits and strategies for new habit development. Individuals in the cLBP wait-list control group and pain-free control group will be asked to maintain current physical activity levels, sedentary behaviors, and medication and/or treatment for low back pain during this period. The investigators hypothesize that 1) objectively-monitored prolonged sedentary behavior will decrease across SUMIT and be maintained at follow-up, 2) cLBP symptoms, mood-related symptoms, and pain psychophysics (e.g pain regulation and modulation) will improve across SUMIT with maintenance of changes at follow-up, and 3) in response to acute exercise, cytokine and endocannabinoid responses post-SUMIT will become more similar to those of controls. If effective, this scalable intervention could be implemented as a behavioral treatment for cLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The 40 participants with chronic low back pain were randomized to either Intervention or Wait-list Control groups, while all 20 healthy control participants did not receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention to Reduce Sedentary TimeThese subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior. This will include an initial, in-person behavioral intervention with a health coach trained and a 4 week phone call. Participants will receive a wrist-worn activity prompter to aid in sedentary behavior reduction. |
| Wait-list Control Group | No intervention | –Chronic low back pain participants in this group will not receive the intervention until completion of the study. Over the 8 week intervention period, participants will be asked to maintain currently levels of physical activity, sedentary behaviors, and treatment for low back pain. |
| Pain-free Control Group | No intervention | –These subjects will be healthy, pain-free adults and receive no intervention. Over the 8 week intervention period, participants in this group will be asked to maintain currently levels of physical activity, sedentary behaviors, and medication regimen. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chronic low back pain (Currently experiencing low back pain every day or nearly every day for longer than 3 months)
- Elevated depressive symptoms (Patient Health Questionnaire-9 greater than or equal to 5)
- Ability to safely complete exercise session (Physical Activity Readiness Questionnaire)
- Willing to wear a physical activity tracker with an idle alert
- Regular access to computer or smartphone
Key exclusion criteria (6 listed)
- Currently using activity tracker with idle alert
- Taking immunomodulatory medication
- Taking anti-depressant medication
- Changed medication or treatment in last 8 weeks
- Have injuries or conditions that prevent change in activity level
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 |
|---|---|---|
| Intervention to Reduce Sedentary TimeChronic low back pain participants in the intervention group will be provided with a wrist-worn activity device that vibrates after prolonged sedentariness and meet with a health coach trained in motivational interviewing to discuss individual sedentary levels and provide education surrounding sitting habits and strategies for new habit development. Participants will meet with the health coach initially and at 4 weeks during the 8 week intervention period. | Behavioural | Intervention Group |
Primary outcome
Change from baseline monitor-assessed sedentary time at 8 weeks
Time frame: baseline and immediately following intervention (8 weeks)
Average daily sedentary time in bouts longer than 60 minutes assessed using thigh worn activPAL monitors. The activPAL classifies time into sedentary, upright and stepping, has been validated for measuring free-living sedentary behaviors and is sensitive to changes in these behaviors.
Change from baseline depressive symptoms at 8 weeks
Time frame: baseline, immediately following intervention (8 weeks), and 3-months after intervention
The Patient Health Questionnaire (PHQ-9), consisting of 9 questions, will be used for participants to report the presence and severity of depressive symptoms over the past 2 weeks. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Change from baseline low back pain symptoms at 8 weeks
Time frame: baseline, immediately following intervention (8 weeks), and 3-months after intervention
The Minimal Dataset for Low Back Pain will be used for participants to report current symptoms of low back pain and impact on daily life. On this questionnaire, for each item a score of 1 is least severe and 5 most severe, with the exception of the single item on pain intensity, which ranges from 0 (no pain) to 10 (worst possible pain). Total scores range from 8 (least impact) to 50 (most impact).
Change from baseline pain sensitivity levels at 8 weeks
Time frame: before exercise at baseline and immediately following intervention (8 weeks)
Pain sensitivity will be asesssed using the Medoc Pathway Pain \& Sensory Evaluation System and applying thermal stimuli to the palm of the non-dominant hand. Subjects will be randomly presented temperatures ranging from 41°to 49°C and asked to rate each stimulus using two separate category-ratio scales to assess pain intensity and unpleasantness.
Change from baseline pain inhibition at 8 weeks
Time frame: after exercise at baseline and immediately following intervention (8 weeks)
Exercise-induced hypoalgesia (EIH) will be used to assess pain inhibition. EIH will be tested by re-administering the pain-sensitivity protocol post exercise.
Change from baseline plasma cytokine levels at 8 weeks
Time frame: before and after exercise at baseline and immediately following intervention (8 weeks)
Blood samples will be collected and processed to determine concentrations of IL-6 and TNF-alpha.
Change from baseline plasma endocannabinoid levels at 8 weeks
Time frame: before and after exercise at baseline and immediately following intervention (8 weeks)
Blood samples will be collected and processed to determine levels of anandamide(AEA) and 2-arachidonoylglycerol (2-AG).
4 secondary outcomes
Change from baseline 36-Item Short Form Survey (SF-36) scores at 8 weeks
Time frame: baseline, immediately following intervention, and 3-months after intervention
Change from baseline Profile of Mood States Short Form scores at 8 weeks
Time frame: baseline, immediately following intervention, and 3-months after intervention
Change from baseline self-reported sedentary time at 8 weeks
Time frame: baseline, immediately following intervention, and 3-months after intervention
Change from baseline monitor-assessed physical activity at 8 weeks
Time frame: baseline and immediately following intervention
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 10 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to Reduce Sedentary Time in people with Chronic Low-back Pain, run by Iowa State University 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 5 inclusion and 6 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 10 Aug 2020. 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?
Change from baseline monitor-assessed sedentary time at 8 weeks (time frame: baseline and immediately following intervention (8 weeks)). The study lists 7 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 10 Aug 2020.