Trial Outcomes & Findings for Pregabalin for Central Sensitization in TKA (NCT NCT05460871)
NCT ID: NCT05460871
Last Updated: 2025-03-04
Results Overview
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Activities of Daily Living subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
TERMINATED
PHASE4
20 participants
Approximately 6 weeks
2025-03-04
Participant Flow
After participants signed their informed consent, the participants completed surveys (Columbia Suicide Severity Rating Screen and Central Sensitization Inventory) to determine if they met the study inclusion criteria. Due to the sensitive nature of these surveys, our local IRB required that informed consent be signed before completing the assessments. If suicidal or the participant did not demonstrate Central Sensitization, they were not eligible for continued participation.
Participant milestones
| Measure |
Control
Participants will receive standard peri-operative pain management
|
Study (Pregabalin)
Participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Control
Participants will receive standard peri-operative pain management
|
Study (Pregabalin)
Participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=1 Participants
Participants will receive standard peri-operative pain management
|
Study (Pregabalin)
n=2 Participants
Participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop.
Pregabalin 75mg: participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, then 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days, then stop.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 0 • n=1 Participants
|
55.5 years
STANDARD_DEVIATION 4.5 • n=2 Participants
|
57.6 years
STANDARD_DEVIATION 4.78 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
|
Grade 3-4 primary osteoarthritis
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
|
no previous adverse reaction to study drug
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed baseline or follow-up surveys.
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Activities of Daily Living subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up survey.
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Symptoms subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5=always.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up survey.
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Stiffness subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up survey.
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Sports and Recreational Activities subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up survey.
The difference in change on the Central Sensitization Inventory assessment will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks follow-up. The survey is scored on a continuous scale as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up assessment.
The change of physical function using the Timed Up \& Go Assessment (TUG) will be evaluated at four intervals during the study; baseline, during the immediate post-operative time period (day of surgery or post-operative day 1), 7-day follow-up, and at 6-week follow-up. Patients will stand up from a chair, walk approximately 10 feet, turn, walk back and sit back down. This activity will be timed in seconds. The change from baseline until 6-week follow-up will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up assessment
The change of physical function using the Stand to Sit Assessment (STS) will be evaluated at four intervals during the study; baseline, during the immediate post-operative time period (day of surgery or post-operative day 1), 7-day follow-up, and at 6-week follow-up. Patients will stand up and sit down from a chair 5 times in a row, as quickly as they can. This activity will be timed in seconds. The change from baseline until 6-week follow-up will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up assessment
The change of physical function using the Patient-Specific Functional Scale Assessment (PSFS) will be evaluated at four intervals during the study; baseline, during the immediate post-operative time period (day of surgery or post-operative day 1), 7-day follow-up, and at 6-week follow-up. At baseline, patients will asked to identify activities they are having difficulty/unable to do and would like to gain the mobility back after procedure. The activities will be scored on a continuous rating with The change from baseline until 6-week follow-up will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed both the baseline and follow-up measurements
Using a numerical rating scale (0-10), patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. The pain scores will be collected on 7-day post procedure follow-up and at the 6-week follow up. The change between the timepoints will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: No subjects completed this.
Review with subjects the type and amount of additional pain (opioid) medication required to control their pain. This will be examined approximately 7-day post procedure and at the 6-week post procedure follow-up. The amount of opioid medication taken by the subject will be converted to morphine equivalents for reporting purposes.
Outcome measures
Outcome data not reported
Adverse Events
Control
Study (Pregabalin)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lee Kral
University of Iowa Hospitals and Clinics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place