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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

ConditionsPeripheral Nerve StimulationGenicular NervesChronic Knee Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • PNS therapy

    Other intervention

    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

    Drug

    Given by Injection

  • Bupivacaine

    Drug

    Given by Injection

  • Placebo

    Other intervention

    Given by Injection

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Group 1 (standard steroid injection)Experimental treatment 2 interventions
Group B: Group 2 (PNS therapy plus 1 standard steroid injection).Experimental treatment 3 interventions
Group C: Group 3 (PNS therapy plus 1 placebo injection)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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