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NCT Number: NCT06004882

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Saba Javed, MD

CONTACT

[email protected]

713-792-9530

Saba Javed, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Triamcinolone

Drug

Given by Injection

Bupivacaine

Drug

Given by Injection

Placebo

Other

Given by Injection

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

    Time frame: through study completion; an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Saba Javed, MD

CONTACT

[email protected]

(713) 792-9530

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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