RecruitingNot ApplicableNCT06004882

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

45 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

OTHERPNS therapy

PNS therapy-NS is a 60-day therapy targeting chronic pain. The procedure involves implanting a small piece of wire next to the nerve causing pain, and the wire is connected to an external device that is then used to apply electric pulses to the nerve, blocking pain signals, for 60 days

DRUGTriamcinolone

Given by Injection

DRUGBupivacaine

Given by Injection

OTHERPlacebo

Given by Injection


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT06004882


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