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

NCT06004882 | Recruiting DMC

• 2 other identifiers: 2023-0041NCI-2023-06513
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Knee Pain; Peripheral Nerve Stimulation; Genicular Nerves

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1 (standard steroid injection)

EXPERIMENTAL

Participants will receive 1 standard steroid injection.

Drug: Triamcinolone; Drug: Bupivacaine

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

EXPERIMENTAL

Participants will receive PNS therapy plus 1 standard steroid injection.

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

Group 3 (PNS therapy plus 1 placebo injection)

EXPERIMENTAL

Participants will receive PNS therapy plus 1 placebo injection.

Other: PNS therapy; Other: Placebo

Interventions

Placebo OTHER

Given by Injection

Group 3 (PNS therapy plus 1 placebo injection)

PNS therapy OTHER

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

Group 2 (PNS therapy plus 1 standard steroid injection).; Group 3 (PNS therapy plus 1 placebo injection)

Triamcinolone DRUG

Given by Injection

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

Bupivacaine DRUG

Given by Injection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Triamcinolone; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Saba Javed, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saba Javed, MD

CONTACT

(713) 792-9530; sjaved@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)