Tracking Outcomes in Pain Patients Using Fitness Devices

Chronic Pain Clinical Trial

Official title:

Tracking Outcomes in Pain Patients Using Fitness Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420457
• Other study ID #: 14-2949
• Status: Completed
• Start date: March 2015
• Est. completion date: May 2018

Study information

• Verified date: April 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.