Clinical trial NCT06004882: Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Nerve Stimulation
Genicular Nerves
Chronic Knee Pain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Saba Javed, MD
role: PRINCIPAL_INVESTIGATOR
References: