Low Back PainNCT03478007
Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
A study testing Intervention Technology and Intervention Technology Plus Coaching in people with Low Back Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intervention Technology and Intervention Technology Plus Coaching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 6 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Diagnosis of chronic low back pain (> 3 months duration)
- Have a current prescription for at-home exercises for chronic low back pain
Who cannot join
- Patients with a high likelihood of being lost to follow-up or contact
- Patients with an inability to provide good data or follow commands
- Patients with an inability to do mild exercise
- Patients with a history of spine surgery that included instrumentation or hardware
- Patients who are taking opioid medication chronically without reasonable reduction in pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. The investigators hypothesize that a device which measures compliance to physical therapy regimens in patients with low back pain will increase patient participation.
Read the detailed description
Innovative Design Labs (IDL) proposes to develop and deploy a low-cost measurement system which tracks exercise compliance and enables remote health coaching for patients with low back pain. The system will consist of a series of small motion sensors built into a custom designed harness which connect wirelessly to the user's tablet or smartphone. A software application will guide the patient through the exercise routine while the sensor system monitors their motion, classifies exercise completion, and tracks their progress through the protocol. The results of the routine will be securely uploaded to caregivers where they can monitor progress, modify the patient's exercise prescription, and offer encouragement and coaching to continue the therapy. This research program aims to enable the long term treatment-tracking of patients with chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Intervention Technology, Intervention Technology Plus Coaching
- Keywords
- Exercise Compliance, Health Coaching
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention TechnologyDevice
Subjects will perform their exercises using the provided monitoring device. They will be able to contact the investigators with questions regarding the use of the monitoring device, however, no encouragement or coaching will be provided
Intervention Technology Plus CoachingDevice
Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.
| Study group | Role | What they receive |
|---|---|---|
| Usual Treatment | No intervention | Usual standard of care (exercises) |
| Intervention Technology Only | Experimental | Exercises with technology alone Receives: Device: Intervention Technology |
| Intervention Technology Plus Coaching | Experimental | Exercises with technology plus coaching Receives: Device: Intervention Technology Plus Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Back Disability Related Quality of Life
Participants will fill out the Modified Oswestry Disability Index, a 10 section questionnaire with 6 possible answers within each section. Statement 1 is graded as 0 points; statement 6 is graded as 5 points. A total score of 50 is possible and would indicate 100% disability. A score of 0-20% indicates minimal disability.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Change in Overall Pain
Participants will fill out the pain Numerical Rating Scale survey, a 4 question survey used to rate intensity of pain from a scale of 0 ("no pain") to 10 ("worst possible pain"). Pain is categorized as mile (1-3), moderate (4-6) or severe (7-10).
Measured: Baseline and 8 weeks
Degree of Compliance
Compliance collected through written diaries (control group) or electronically recorded compliance monitoring. Compliance will be defined on whether or not the subject completed the assigned exercises each day.
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start21 Aug 2019
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Design Labs, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kenton R. Kaufman, PhD, PE, Mayo Clinic
- Investigators
- Kenton R Kaufman, Ph.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478007
- Sponsor's protocol ID
- 16-002177
- Other IDs
- R44AG055152-02A1
- Status last verified
- Apr 2022
- First submitted
- 20 Mar 2018
- Last updated
- 14 Apr 2022
- 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03478007
- Acronym / sponsor ID
- 16-002177
- Conditions
- Low Back Pain
- Keywords
- Exercise Compliance, Health Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Innovative Design Labs, National Institute on Aging (NIA)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 27 Mar 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.
The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. The investigators hypothesize that a device which measures compliance to physical therapy regimens in patients with low back pain will increase patient participation.
Detailed description
Innovative Design Labs (IDL) proposes to develop and deploy a low-cost measurement system which tracks exercise compliance and enables remote health coaching for patients with low back pain. The system will consist of a series of small motion sensors built into a custom designed harness which connect wirelessly to the user's tablet or smartphone. A software application will guide the patient through the exercise routine while the sensor system monitors their motion, classifies exercise completion, and tracks their progress through the protocol. The results of the routine will be securely uploaded to caregivers where they can monitor progress, modify the patient's exercise prescription, and offer encouragement and coaching to continue the therapy. This research program aims to enable the long term treatment-tracking of patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Treatment | No intervention | –Usual standard of care (exercises) |
| Intervention Technology Only | Experimental | Device: Intervention TechnologyExercises with technology alone |
| Intervention Technology Plus Coaching | Experimental | Device: Intervention Technology Plus CoachingExercises with technology plus coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Diagnosis of chronic low back pain (> 3 months duration)
- Have a current prescription for at-home exercises for chronic low back pain
Key exclusion criteria (5 listed)
- Patients with a high likelihood of being lost to follow-up or contact
- Patients with an inability to provide good data or follow commands
- Patients with an inability to do mild exercise
- Patients with a history of spine surgery that included instrumentation or hardware
- Patients who are taking opioid medication chronically without reasonable reduction in pain
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 TechnologySubjects will perform their exercises using the provided monitoring device. They will be able to contact the investigators with questions regarding the use of the monitoring device, however, no encouragement or coaching will be provided | Device | Intervention Technology Only |
| Intervention Technology Plus CoachingSubjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call. | Device | Intervention Technology Plus Coaching |
Primary outcome
Change in Back Disability Related Quality of Life
Time frame: Baseline and 8 weeks
Participants will fill out the Modified Oswestry Disability Index, a 10 section questionnaire with 6 possible answers within each section. Statement 1 is graded as 0 points; statement 6 is graded as 5 points. A total score of 50 is possible and would indicate 100% disability. A score of 0-20% indicates minimal disability.
2 secondary outcomes
Change in Overall Pain
Time frame: Baseline and 8 weeks
Degree of Compliance
Time frame: 4 and 8 weeks
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 14 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Kenton R Kaufman, Ph.D principal investigator
Mayo Clinic
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 Technology and Intervention Technology Plus Coaching in people with Low Back Pain, run by Mayo Clinic 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 5 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 14 Apr 2022. 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 in Back Disability Related Quality of Life (time frame: Baseline and 8 weeks). 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 14 Apr 2022.