Tracking Outcomes in Pain Patients Using Fitness Devices

Study Overview
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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.

Official Title
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Tracking Outcomes in Pain Patients Using Fitness Devices

Conditions
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Chronic Pain, Back Pain

Intervention / Treatment
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* Procedure: Epidural injection
* Drug: Epidural steroid injection as determined by routine care provider


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Back pain receiving epidural injection<br>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 | Procedure: Epidural injection<br>* 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.<br>Drug: Epidural steroid injection as determined by routine care provider<br>* Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Follow-up assessment approximately 2-4 weeks following epidural procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Follow-up assessment approximately 2-4 weeks following the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fitness devices