What is the mechanism of action of this treatment?

Pregabalin, a common treatment for Central Sensitization Syndrome (CSS), works by modulating the release of neurotransmitters to reduce pain and central sensitization. This is particularly important for CSS patients because the condition involves an increased sensitivity of the central nervous system to pain stimuli. By decreasing the abnormal pain signaling, pregabalin helps alleviate the heightened pain response. Other treatments for CSS may include anticonvulsants and antidepressants, which also aim to modulate neurotransmitter activity and reduce central nervous system hyperactivity.

What side effects are associated with this type of intervention?

Pregabalin, used to modulate neurotransmitter release and reduce pain in Central Sensitization Syndrome, is generally well-tolerated but can cause side effects such as dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and difficulty concentrating. Gabapentin, a similar medication, shares many of these side effects and can also cause headache, dizziness, and disorientation. Both medications require careful dose adjustments, especially in patients with renal impairment. Other treatments for central sensitization, such as transcranial magnetic stimulation (TMS), may cause mild side effects like tingling or discomfort at the stimulation site but are generally well-tolerated.

What prior FDA approvals exist?

Pregabalin and gabapentin are FDA-approved drugs that modulate neurotransmitter release to reduce pain and central sensitization. Pregabalin is approved for conditions like neuropathic pain, fibromyalgia, and as an adjunctive therapy for partial seizures. Gabapentin is similarly approved for postherpetic neuralgia and as an adjunctive treatment for partial seizures. Both drugs are used off-label for various pain syndromes, including those involving central sensitization.

What other types of research exist?

Promising alternatives to Pregabalin for Central Sensitization Syndrome include: 1) Gabapentin, which also modulates neurotransmitter release and has shown efficacy in neuropathic pain; 2) Amitriptyline, a tricyclic antidepressant effective in neuropathic pain and fibromyalgia; 3) Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI) used for chronic pain conditions; 4) Capsaicin 8% dermal patch, which provides localized pain relief by desensitizing sensory neurons; 5) Non-pharmacological interventions such as cognitive-behavioral therapy (CBT) and physical therapy, which can help manage pain and improve function.

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Pregabalin for Osteoarthritis Pain

Phase 4

Waitlist Available

Led By Lee Kral, Pharm. D.

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if pregabalin can help reduce pain and improve function in patients with an overactive pain response undergoing knee replacement surgery. Pregabalin works by calming the nerves, making them less sensitive to pain. Pregabalin is a well-accepted treatment option for patients with nerve pain.

Who is the study for?

This trial is for people aged 50-85 with severe primary osteoarthritis needing knee replacement surgery, who are non-smokers for over two years and score at least 40 on the Central Sensitization Inventory. Excluded are those taking high doses of opioids, with poor kidney function, pregnant women or potential to become pregnant, prisoners, non-English speakers, suicidal individuals or current/recent users of pregabalin.

What is being tested?

The study tests if pregabalin can improve pain and function in patients with central sensitization undergoing total knee arthroplasty (TKA). Participants will either receive standard care or add pregabalin before and after surgery. They'll be monitored through physical therapy assessments and surveys about their pain levels and opioid use.

What are the potential side effects?

Possible side effects from pregabalin include dizziness, sleepiness, dry mouth, swelling in limbs, blurred vision, weight gain and difficulty concentrating. Patients will report any adverse effects they experience during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Stiffness

Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Symptoms

+6 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study (Pregabalin)Experimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

Participants will receive standard peri-operative pain management

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pregabalin 75mg

2011

Completed Phase 4

~690

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pregabalin, a common treatment for Central Sensitization Syndrome (CSS), works by modulating the release of neurotransmitters to reduce pain and central sensitization. This is particularly important for CSS patients because the condition involves an increased sensitivity of the central nervous system to pain stimuli. By decreasing the abnormal pain signaling, pregabalin helps alleviate the heightened pain response. Other treatments for CSS may include anticonvulsants and antidepressants, which also aim to modulate neurotransmitter activity and reduce central nervous system hyperactivity.

Pregabalin suppresses nociceptive behavior and central sensitization in a rat trigeminal neuropathic pain model.Pregabalin attenuates place escape/avoidance behavior in a rat model of spinal cord injury.