Tracking Outcomes in Pain Patients Using Fitness Devices

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

Study Overview

• Status: Completed
• Conditions: Back Pain; Chronic Pain
• Intervention / Treatment: Procedure: Epidural injection; Drug: Epidural steroid injection as determined by routine care provider

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 275997010
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic back pain

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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.; Drug: Epidural steroid injection as determined by routine care provider; Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Matthew C Mauck, MD PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Fitness devices
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 14-2949