Recruiting

Peripheral Nerve Stimulation vs. Intra-articular Steroid Injection

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06004882

Conditions

Peripheral Nerve Stimulation

Genicular Nerves

Chronic Knee Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PNS therapy

Triamcinolone

Bupivacaine

Placebo

Study Details

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

Peripheral Nerve Stimulation

Genicular Nerves

Chronic Knee Pain

Study ID

NCT06004882

Start date

Aug 10, 2023

Status verified date

Aug, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 (standard steroid injection)

Participants will receive 1 standard steroid injection.

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

Participants will receive PNS therapy plus 1 standard steroid injection.

experimental: Group 3 (PNS therapy plus 1 placebo injection)

Participants will receive PNS therapy plus 1 placebo injection.

Interventions

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

Triamcinolone

Given by Injection

Bupivacaine

Given by Injection

Placebo

Given by Injection

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Saba Javed, MD

(713) 792-9530sjaved@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Saba Javed, MD

713-792-9530sjaved@mdanderson.org

Principal Investigator:

Saba Javed, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-12.