Chronic PainNCT02420457
Tracking Outcomes in Pain Patients Using Fitness Devices
An observational study of Chronic Pain and Back Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Back Pain
- What is being tested?
- Epidural injection and Epidural steroid injection as determined by routine care provider
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to May 2018
- Phase
- Observational
- 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
Study population: Adult patients with chronic back pain
Who may be able to join
- Back pain which may benefit from epidural injection
- Assenting to epidural injection for back pain
Who cannot join
- Inability to wear fitness tracking device
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill
Chapel Hill, North Carolina, 275997010
About this study
The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.
Read the detailed description
The investigators are attempting to validate the usage of personal fitness trackers against the classical survey tools used. These devices are known to be of use in measuring activity and sleep in healthy patients but their use in chronic pain patients has not been assessed. This study will follow participants with chronic back pain undergoing treatment to see if changes in clinical course can be captured with these fitness devices.
- Conditions
- Chronic Pain, Back Pain
- Being tested
- Epidural injection, Epidural steroid injection as determined by routine care provider
- Keywords
- Fitness devices
- Medical subject headings
- Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural injectionProcedure or surgery
After evaluation by their pain physician, if the clinician offers an epidural injection for their back pain, they will be followed for this study before and after the injection.
Epidural steroid injection as determined by routine care providerDrug
Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Back pain receiving epidural injection | Patients who have chronic back pain and are scheduled for an epidural injection to treat this pain will be receive a transforaminal epidural steroid injection as determined by routine care provider Receives: Procedure: Epidural injection; Drug: Epidural steroid injection as determined by routine care provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of percent improvement in pain and number of steps.
Linear regression will be used to determine the association of change in percent improvement of pain (assessed at baseline and follow-up) and number of steps taken on average the week of the assessment. Increased beta-coefficient from linear regression demonstrates that increased improvement in pain is related to an increased number of steps indicating improved mobility. If the beta coefficient from the linear regression is negative, this indicates that percent improvement in pain is associated with decreased number of steps and reduced mobility.
Measured: Follow-up assessment approximately 2-4 weeks following epidural procedure.
Secondary outcomes (3)
Change in pain severity following procedure
Pain will be assessed by using a Visual Analog Scale (VAS) where scores range from 0 = no pain to 100 = worst possible pain. An increase in pain scores from baseline represent disease progression and decrease represent clinical response to treatment. VAS will be assessed prior to treatment and then at a followup assessment.
Measured: Follow-up timepoint approximately 2-4 weeks following procedure
Association in minutes slept as measured by fitness device and percent improvement in pain
Linear regression will be used to determine the association of change in percent improvement of pain (assessed at baseline and follow-up) and number of minutes slept on average the week of the assessment. Increased beta-coefficient from linear regression demonstrates that increased improvement in pain is related to an increased number of steps indicating improved mobility. If the beta coefficient from the linear regression is negative, this indicates that percent improvement in pain is associated with decreased number of steps and reduced mobility.
Measured: Follow-up assessment approximately 2-4 week following procedure
Change in survey measures of pain
Conglomerate survey device of brief pain inventory, roland morris disability questionnaire, and oswestry disability index. The investigators will measure baseline survey data before the treatment and then at follow up visit.
Measured: Follow-up assessment approximately 2-4 weeks following the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Matthew C Mauck, MD PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420457
- Sponsor's protocol ID
- 14-2949
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Outcomes in Pain Patients Using Fitness Devices
- ClinicalTrials.gov ID
- NCT02420457
- Acronym / sponsor ID
- 14-2949
- Conditions
- Chronic Pain, Back Pain
- Keywords
- Fitness devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- Mar 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Apr 2015 (estimated)
- 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 investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.
Detailed description
The investigators are attempting to validate the usage of personal fitness trackers against the classical survey tools used. These devices are known to be of use in measuring activity and sleep in healthy patients but their use in chronic pain patients has not been assessed. This study will follow participants with chronic back pain undergoing treatment to see if changes in clinical course can be captured with these fitness devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Back pain receiving epidural injection | – | Procedure: Epidural injection, Drug: Epidural steroid injection as determined by routine care providerPatients who have chronic back pain and are scheduled for an epidural injection to treat this pain will be receive a transforaminal epidural steroid injection as determined by routine care provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic back pain
Key inclusion criteria (2 listed)
- Back pain which may benefit from epidural injection
- Assenting to epidural injection for back pain
Key exclusion criteria (1 listed)
- Inability to wear fitness tracking device
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 |
|---|---|---|
| Epidural injectionAfter evaluation by their pain physician, if the clinician offers an epidural injection for their back pain, they will be followed for this study before and after the injection. | Procedure or surgery | Back pain receiving epidural injection |
| Epidural steroid injection as determined by routine care providerBetamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline | Drug | Back pain receiving epidural injection |
Primary outcome
Association of percent improvement in pain and number of steps.
Time frame: Follow-up assessment approximately 2-4 weeks following epidural procedure.
Linear regression will be used to determine the association of change in percent improvement of pain (assessed at baseline and follow-up) and number of steps taken on average the week of the assessment. Increased beta-coefficient from linear regression demonstrates that increased improvement in pain is related to an increased number of steps indicating improved mobility. If the beta coefficient from the linear regression is negative, this indicates that percent improvement in pain is associated with decreased number of steps and reduced mobility.
3 secondary outcomes
Change in pain severity following procedure
Time frame: Follow-up timepoint approximately 2-4 weeks following procedure
Association in minutes slept as measured by fitness device and percent improvement in pain
Time frame: Follow-up assessment approximately 2-4 week following procedure
Change in survey measures of pain
Time frame: Follow-up assessment approximately 2-4 weeks following the procedure.
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 25 Apr 2019.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Matthew C Mauck, MD PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Back Pain, run by University of North Carolina, Chapel Hill 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 2 inclusion and 1 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 25 Apr 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?
Association of percent improvement in pain and number of steps. (time frame: Follow-up assessment approximately 2-4 weeks following epidural procedure.). 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 25 Apr 2019.