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

Status: Enrolling

Conditions: Chronic Knee Pain; Genicular Nerves; Peripheral Nerve Stimulation

Treatments: Drug: Bupivacaine; Other: Placebo; Other: PNS therapy; Drug: Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06004882

2023-0041

NCI-2023-06513 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Group 1 (standard steroid injection)

Experimental group

Description:

Participants will receive 1 standard steroid injection.

Treatment:

Drug: Triamcinolone

Drug: Bupivacaine

Group 2 (PNS therapy plus 1 standard steroid injection).

Experimental group

Description:

Participants will receive PNS therapy plus 1 standard steroid injection.

Treatment:

Drug: Triamcinolone

Other: PNS therapy

Drug: Bupivacaine

Group 3 (PNS therapy plus 1 placebo injection)

Experimental group

Description:

Participants will receive PNS therapy plus 1 placebo injection.

Treatment:

Other: PNS therapy

Other: Placebo