Pain, Postoperative Clinical Trial
— P1RESPECTOfficial title:
Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores
Verified date | April 2021 |
Source | InCaveo |
Contact | Cynthia Harris, BS |
Phone | 8326776747 |
cindy[@]clinregconsult.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
InCaveo |
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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