Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PNS therapy, Triamcinolone, Bupivacaine, Placebo.
- Who it may be relevant to
- Registry conditions: Peripheral Nerve Stimulation, Genicular Nerves, Chronic Knee Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 - Drug Bupivacaine
Given by Injection - Other Placebo
Given by Injection
Primary outcome measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT06004882 · 2023-0041 · NCI-2023-06513