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Completed

NCT Number: NCT02420457

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.

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Key information

Conditions

Chronic Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 275997010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural injection

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

Drug

Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in pain severity following procedure

    Time frame: 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.

  2. 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

    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.

  3. Change in survey measures of pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2015
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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