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NCT05460871 · ClinicalTrials.gov registry record · Phase 4
Pregabalin for Central Sensitization in TKA
A Phase 4 study, sponsored by University of Iowa.
- Terminated
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT05460871 is a Phase 4 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 20 participants.
The verdict
NCT05460871, a Phase 4 study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Participants will be identified who are indicated for TKA. Interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet inclusion criteria and agree to participate, they will complete the informed consent before being randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. They will also be scheduled to have a pre-operative physical therapy (PT) appointment which will include tests and measures standard to PT. Tests will include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures. On the day of surgery participants will be asked about any adverse effects of study medication and determine need to withdraw from study. The post-operative plan will be reviewed, including dose of study medication. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA . All participants will complete standard of practice physical therapy. After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. The study pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average). At the 6 week pos
Interventions
- DRUG Pregabalin 75mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-02-21 |
| Est. Completion | 2024-01-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05460871
The ClinicalTrials.gov registry entry for NCT05460871 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pregabalin 75mg is the first listed.
NCT05460871 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05460871 about?
NCT05460871 is a clinical study titled "Pregabalin for Central Sensitization in TKA". The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Participants will be identified who are indicated for TKA. Interested patients will complete...
What is the current status of trial NCT05460871?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2023-02-21. Estimated completion is 2024-01-25.
What interventions are being tested in trial NCT05460871?
The interventions under investigation include: Pregabalin 75mg (DRUG).
Who is sponsoring clinical trial NCT05460871?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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