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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04836169
Other study ID # InCaveoDanielandDaniel2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date May 2022

Study information

Verified date April 2021
Source InCaveo
Contact Cynthia Harris, BS
Phone 8326776747
Email cindy@clinregconsult.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system with integrated mobile CBT but without tapering to improve The Pain Catastrophizing Scale (PCS) scores, and secondarily scores on the VNS pain scale, the Tampa Scale of Kinesiophobia (TSK), and patient satisfaction scores in the subacute period (defined as 2 weeks to 3 months post TKR). Statistically significant positive results on the Pain Catastrophizing Scale (PCS) will trigger phase 2. Phase 1 will also inform the detailed conditions and patient management algorithms for Phase II.


Description:

The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy (CBT) built into a mobile software app, patient medication usage, and tracking of patient PROs. It is designed to be used alongside Usual Standard of Care using Pill Bottles or to simplify, Usual Care with Pill Bottles (UCPB) treatment practices. The InCaveo EOA System is designed to improve a set of patient outcome measures, primarily Pain Catastrophizing Scale (PCS) and secondarily the Visual Numeric Pain (VNS), Kinesiophobia (TSK) and satisfaction scores while facilitating the ability of patients to taper off their pain medication faster than through the use of USPB in the management of post-operative pain. In order to reduce confounding variables, the study will focus on pain management following a single surgical procedure: Total Knee Replacement (TKR) surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: 1. Patient has a Pain Catastrophizing Score >16 2. 55 years of age and older. 3. English speaking. 4. Has a smartphone (iPhone). 5. Able to swallow oral medications. 6. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery. 7. Undergoing TKR surgery. 8. Patients who are willing and able to comply with scheduled visits and study procedures. Exclusion Criteria: 1. Diagnosed with Opioid Use Disorder (OUD). 2. Actively using illicit drugs. 3. Allergy to opioids 4. Older than 85 years

Study Design


Related Conditions & MeSH terms


Intervention

Device:
InCaveo's EOA system with integrated mobile CBT
integrated pain management therapeutic and tapering system including a software apt that manages and tracks patient-reported outcomes, including pain levels, medication use, quality of life

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
InCaveo

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Catastrophizing Scale (PCS) A measure of the extent of catastrophizing 60 days
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