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NCT06004882NARecruiting

Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study

M.D. Anderson Cancer Center

Start Date

8/10/2023

Completion Date

1/31/2027

Summary

To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain: * A standard steroid injection * Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid injection * PNS therapy in combination with a placebo injection Steroid injections are given directly into the knee joints and are considered to be the standard therapy for chronic knee pain. In this study, the injection will be made of the steroid drugs triamcinolone and bupivacaine.

Detailed Description

Primary Objectives: * To compare the mean change in knee range of motion using goniometry from at 30 days (visit 2) from baseline among the three treatment arms. Secondary Objectives: * To compare the mean change in knee range of motion using goniometry at 60 days (visit 3) and 90 days (visit 4) from baseline among the three treatment arms. * To compare changes in knee pain scores (NRS), WOMAC index, use of opioids (measured in morphine milliequivalent), and incidence of complications and adverse effects at 30 days, 60 days, and 90 days from baseline among the three treatment arms

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients diagnosed with chronic knee pain (baseline pain score \>=4), seen at Pain Management Center at MD Anderson Cancer Center; if patient has bilateral knee pain, the side with the more severe knee pain will be treated first and counted towards the primary and secondary endpoints * Patients between ages 18-85 years old * Patient signed informed consent Exclusion Criteria: * Patients with cognitive dysfunction or without capacity to consent * Patient with recent history (\<6 months) of drug or alcohol abuse * Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection * Patients with allergies to local anesthesia, steroids, or adhesives * Patients who are on opioids for reasons other than knee pain

Interventions

OTHER

PNS therapy

DRUG

Triamcinolone

DRUG

Bupivacaine

OTHER

Placebo

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Conditions

Peripheral Nerve StimulationGenicular NervesChronic Knee Pain

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States