Pregabalin for Central Sensitization in TKA

NCT05460871 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 202105361
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee; Central Nervous System Sensitization

Keywords

Arthroplasty; Pain; Central Nervous System Sensitization; Osteo Arthritis Knee; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Calculate the Change Using the Knee Osteoarthritis Outcome Survey- Activities of Daily Living Subscale

  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.

  Approximately 6 weeks

Secondary Outcomes (9)

• Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Symptoms

  Approximately 6 weeks

• Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Stiffness

  Approximately 6 weeks

• Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Sports and Recreational Activities

  Approximately 6 weeks

• Calculate the Change in Central Sensitization Inventory Score

  Approximately 6 weeks

• Calculate the Change of Physical Function Using the Timed Up & Go Assessment

  Approximately 6 weeks

Study Arms (2)

Control

NO INTERVENTION

Participants will receive standard peri-operative pain management

Study (Pregabalin)

EXPERIMENTAL

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.

Drug: Pregabalin 75mg

Interventions

Pregabalin 75mg DRUG

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.

Also known as: Study

Study (Pregabalin)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 for the past 1 month
• Patients with an estimate GFR \< 30 ml/min
• Patients who do not have an understanding of English
• Patients who are pregnant or women of child-bearing years
• Patients who are prisoners
• Patients who score \< 40 on the CSI
• Patients who answer Yes to any questions on the Columbia Suicide Severity Rating Scale or express suicidal ideation

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Lee Kral
• Organization: University of Iowa Hospitals and Clinics

lee-kral@uiowa.edu

(319) 384-6593

Study Officials

• Lee Kral, Pharm. D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Open label interventional trial

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: February 21, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 18, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)