Pregabalin for Central Sensitization in TKA

• Status: Not yet recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: All

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 post-operative visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine MME based on patient report of quantity of opioid medication used. A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lee A. Kral
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Patients undergoing native joint unilateral TKA due to Grade 3-4 primary osteoarthritis

• Patients with score of at least 40 on Central Sensitization Inventory

• Patients who will complete PT within the U of Iowa Health Care system

• Patients who have been nonsmokers for > 2 years

• Patients between the ages of 50 and 85

Exclusion Criteria:

• Patients already taking pregabalin or had an adverse effect with pregabalin in the past

• Patients indicated for joint revision surgery

• Patients taking at least 30 morphine milligram equivalents per day

• Patients with an estimate GFR < 30 ml/min

• Patients who do not have an understanding of English

• Patients who are pregnant

• Patients who are prisoners