Tracking Outcomes in Pain Patients Using Fitness Devices
24 april 2019 uppdaterad av: University of North Carolina, Chapel Hill
The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
36
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 275997010
- UNC Chapel Hill
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adult patients with chronic back pain
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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
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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.
Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Association of percent improvement in pain and number of steps.
Tidsram: Follow-up assessment approximately 2-4 weeks following epidural procedure.
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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.
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Follow-up assessment approximately 2-4 weeks following epidural procedure.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in pain severity following procedure
Tidsram: Follow-up timepoint approximately 2-4 weeks following procedure
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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.
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Follow-up timepoint approximately 2-4 weeks following procedure
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Association in minutes slept as measured by fitness device and percent improvement in pain
Tidsram: 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.
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Follow-up assessment approximately 2-4 week following procedure
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Change in survey measures of pain
Tidsram: Follow-up assessment approximately 2-4 weeks following the procedure.
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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.
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Follow-up assessment approximately 2-4 weeks following the procedure.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Matthew C Mauck, MD PhD, Assistant Professor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2015
Primärt slutförande (Faktisk)
1 maj 2018
Avslutad studie (Faktisk)
1 maj 2018
Studieregistreringsdatum
Först inskickad
31 mars 2015
Först inskickad som uppfyllde QC-kriterierna
14 april 2015
Första postat (Uppskatta)
17 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14-2949
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .