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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Peripheral Nerve Stimulation, Genicular Nerves, Chronic Knee Pain

Intervention / Treatment
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* Other: PNS therapy
* Drug: Triamcinolone
* Drug: Bupivacaine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (standard steroid injection)<br>Participants will receive 1 standard steroid injection. | Drug: Triamcinolone<br>* Given by Injection<br>Drug: Bupivacaine<br>* Given by Injection<br>|
| Experimental: Group 2 (PNS therapy plus 1 standard steroid injection).<br>Participants will receive PNS therapy plus 1 standard steroid injection. | Other: PNS therapy<br>* 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<br>Drug: Triamcinolone<br>* Given by Injection<br>Drug: Bupivacaine<br>* Given by Injection<br>|
| Experimental: Group 3 (PNS therapy plus 1 placebo injection)<br>Participants will receive PNS therapy plus 1 placebo injection. | Other: PNS therapy<br>* 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<br>Other: Placebo<br>* Given by Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |