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

Chronic Knee Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004882
• Other study ID #: 2023-0041
• Secondary ID: NCI-2023-06513
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Saba Javed, MD
• Phone: (713) 792-9530
• Email: sjaved[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Knee Pain

Intervention

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

Drug:
• Triamcinolone
Given by Injection
• Bupivacaine
Given by Injection

Other:
• Placebo
Given by Injection

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center