Tracking Outcomes in Pain Patients Using Fitness Devices

Completed

• Conditions: Chronic Pain; Back Pain
• Interventions: Procedure: Epidural injection; Drug: Epidural steroid injection as determined by routine care provider

• Registration Number: NCT02420457
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Back pain receiving epidural injection	Epidural steroid injection as determined by routine care provider	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
Back pain receiving epidural injection	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

Primary Outcome Measures

Name	Time	Method
Association of percent improvement in pain and number of steps.	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.

Secondary Outcome Measures

Name	Time	Method
Change in survey measures of pain	Follow-up assessment approximately 2-4 weeks following the procedure.	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.
Change in pain severity following procedure	Follow-up timepoint approximately 2-4 weeks 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.
Association in minutes slept as measured by fitness device and percent improvement in pain	Follow-up assessment approximately 2-4 week following 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 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.

Trial Locations

Locations (1)

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States