Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
- Conditions
- Genicular NervesPeripheral Nerve StimulationChronic Knee Pain
- Interventions
- Registration Number
- NCT06004882
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 2 (PNS therapy plus 1 standard steroid injection). PNS therapy Participants will receive PNS therapy plus 1 standard steroid injection. Group 2 (PNS therapy plus 1 standard steroid injection). Triamcinolone Participants will receive PNS therapy plus 1 standard steroid injection. Group 3 (PNS therapy plus 1 placebo injection) PNS therapy Participants will receive PNS therapy plus 1 placebo injection. Group 3 (PNS therapy plus 1 placebo injection) Placebo Participants will receive PNS therapy plus 1 placebo injection. Group 1 (standard steroid injection) Triamcinolone Participants will receive 1 standard steroid injection. Group 1 (standard steroid injection) Bupivacaine Participants will receive 1 standard steroid injection. Group 2 (PNS therapy plus 1 standard steroid injection). Bupivacaine Participants will receive PNS therapy plus 1 standard steroid injection.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States