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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Knee Pain; Peripheral Nerve Stimulation; Genicular Nerves
• Intervention / Treatment: Drug: Triamcinolone; Drug: Bupivacaine; Other: PNS therapy; Other: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saba Javed, MD; Phone Number: (713) 792-9530; Email: sjaved@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Saba Javed, MD; Phone Number: 713-792-9530; Email: sjaved@mdanderson.org
      • Principal Investigator: Saba Javed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (standard steroid injection); Participants will receive 1 standard steroid injection.	Drug: Triamcinolone; Given by Injection; Drug: Bupivacaine; Given by Injection
Experimental: Group 2 (PNS therapy plus 1 standard steroid injection).; Participants will receive PNS therapy plus 1 standard steroid injection.	Drug: Triamcinolone; Given by Injection; Drug: Bupivacaine; Given by Injection; 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
Experimental: Group 3 (PNS therapy plus 1 placebo injection); Participants will receive PNS therapy plus 1 placebo injection.	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; Other: Placebo; Given by Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0	through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Saba Javed, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Bupivacaine; Triamcinolone
• Other Study ID Numbers: 2023-0041; NCI-2023-06513 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No