Actively Recruiting
Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
Led by M.D. Anderson Cancer Center · Updated on 2026-03-03
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different therapies to improve knee range of motion in patients with chronic knee pain. The study compares a standard steroid injection, peripheral nerve stimulation (PNS) therapy combined with a steroid injection, and PNS therapy with a placebo injection. Steroid injections, containing triamcinolone and bupivacaine, are the usual treatment, and this study aims to explore the effects of adding PNS therapy alongside or instead of steroids. Participants are assigned to one of three groups: one receiving a steroid injection only, another receiving PNS therapy along with a steroid injection, and the third receiving PNS therapy plus a placebo injection. PNS therapy involves implanting a small wire near the nerve causing pain, which is connected to an external device delivering electrical pulses for 60 days to block pain signals. The steroid injection is given directly into the knee joint. During the study, knee range of motion is measured using goniometry at baseline, 30, 60, and 90 days to assess changes. Researchers also track knee pain scores, use of opioids, and any complications or adverse effects. Safety is monitored through adverse event reporting averaged over one year. Participants are evaluated at multiple visits to monitor progress and outcomes throughout the study period.
CONDITIONS
Brief Title
Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with chronic knee pain with a baseline pain score of 4 or higher
- Patients aged between 18 and 85 years old
- Patients who have signed informed consent
- If bilateral knee pain, the more severe side will be treated and counted toward study outcomes
You will not qualify if you...
- Patients with cognitive dysfunction or without capacity to consent
- Patients with recent history (less than 6 months) of drug or alcohol abuse
- Patients with open skin lesions or currently on antibiotics for local or systemic infection
- Patients allergic to local anesthesia, steroids, or adhesives
- Patients on opioids for reasons other than knee pain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 60 days
Participants receive one of three interventions: a standard steroid injection alone, peripheral nerve stimulation (PNS) therapy plus a standard steroid injection, or PNS therapy plus a placebo injection. PNS therapy involves implanting a wire to deliver electrical pulses blocking pain signals for 60 days.
1 treatment visit (in-person)
Duration - Up to 90 days from baseline
Participants are monitored for changes in knee range of motion, knee pain scores, opioid use, and any complications or adverse effects.
3 follow-up visits at 30, 60, and 90 days (in-person)
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Saba Javed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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