NCT06004882

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peripheral Nerve Stimulation
• Genicular Nerves
• Chronic Knee Pain

Interventions

Type	Name	Description
OTHER	PNS 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
DRUG	Triamcinolone	Given by Injection
DRUG	Bupivacaine	Given by Injection
OTHER	Placebo	Given by Injection

Timeline

• Start date: 2023-08-10
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2023-08-22
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States