Tracking Outcomes in Pain Patients Using Fitness Devices

NCT ID: NCT02420457

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-05-31

Brief Summary

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The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.

Detailed Description

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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

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Chronic Pain Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Epidural injection

Intervention Type PROCEDURE

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 provider

Intervention Type DRUG

Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline

Interventions

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Epidural injection

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.

Intervention Type PROCEDURE

Epidural steroid injection as determined by routine care provider

Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Back pain which may benefit from epidural injection
* Assenting to epidural injection for back pain

Exclusion Criteria

* Inability to wear fitness tracking device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew C Mauck, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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14-2949

Identifier Type: -

Identifier Source: org_study_id

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