Tracking Outcomes in Pain Patients Using Fitness Devices

NCT02420457 | Completed

• 1 other identifier: 14-2949
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain; Back Pain

Keywords

Fitness devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in pain severity following procedure

  Follow-up timepoint approximately 2-4 weeks following procedure

• Association in minutes slept as measured by fitness device and percent improvement in pain

  Follow-up assessment approximately 2-4 week following procedure

• Change in survey measures of pain

  Follow-up assessment approximately 2-4 weeks following the procedure.

Study Arms (1)

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; Drug: Epidural steroid injection as determined by routine care provider

Interventions

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.

Back pain receiving epidural injection

Epidural steroid injection as determined by routine care provider DRUG

Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline

Back pain receiving epidural injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic back pain

You may qualify if:

• Back pain which may benefit from epidural injection
• Assenting to epidural injection for back pain

You may not qualify if:

• Inability to wear fitness tracking device

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 275997010, United States

Location

MeSH Terms

Conditions

Chronic Pain; Back Pain

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Matthew C Mauck, MD PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 17, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (1)