Chronic Pain, Back Pain
Conditions
Keywords
Fitness devices
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.
Interventions
PROCEDUREEpidural 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.
DRUGEpidural steroid injection as determined by routine care provider
Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed