This clinical trial compares the effect of peripheral nerve stimulation (PNS) of the knee (genicular) nerves to conventional therapy with an intra-articular (into a joint) steroid injection for improving chronic knee pain. PNS is a 60-day therapy that 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. 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 drug triamcinolone, as well as the anesthetic drug bupivacaine. Adding PNS to conventional intra-articular steroid injection may reduce pain in the knee and improve mobility.
Additional locations may be listed on ClinicalTrials.gov for NCT06004882.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Saba Javed
Phone: 713-792-9530
PRIMARY OBJECTIVE:
I. 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:
I. 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.
II. To compare changes in knee pain scores (Numeric Rating Score [NRS]), Western Ontario and McMaster Universities Arthritis Index (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.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM 1: Patients undergo fluoroscopy or ultrasound imaging and receive triamcinolone acetonide and bupivacaine once intra-articularly.
ARM 2: Patients undergo fluoroscopy or ultrasound imaging and receive triamcinolone acetonide and bupivacaine once intra-articularly. Patients also undergo peripheral nerve stimulation over 30-45 minutes for 60 days in the absence of unacceptably toxicity.
ARM 3: Patients undergo fluoroscopy or ultrasound imaging and receive placebo (saline) once via injection into the joint space. Patients also undergo peripheral nerve stimulation over 30-45 minutes for 60 days in the absence of unacceptably toxicity.
After completion of study treatment, patients are followed up at 30, 60, and 90 days from baseline.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSaba Javed
