Chronic Knee Pain, Genicular Nerves, Peripheral Nerve Stimulation
Conditions
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
Interventions
OTHERPNS 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
DRUGTriamcinolone
Given by Injection
DRUGBupivacaine
Given by Injection
OTHERPlacebo
Given by Injection
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTSaba Javed, MD
PRINCIPAL_INVESTIGATORSaba Javed, MD
M.D. Anderson Cancer Center
Outcome results
None listed