Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 2 (PNS therapy plus 1 standard steroid injection).
Participants will receive PNS therapy plus 1 standard steroid injection.
Intervention: PNS therapy (Other)
Group 3 (PNS therapy plus 1 placebo injection)
Participants will receive PNS therapy plus 1 placebo injection.
Intervention: PNS therapy (Other)
Group 3 (PNS therapy plus 1 placebo injection)
Participants will receive PNS therapy plus 1 placebo injection.
Intervention: Placebo (Other)
Group 1 (standard steroid injection)
Participants will receive 1 standard steroid injection.
Intervention: Triamcinolone (Drug)
Group 1 (standard steroid injection)
Participants will receive 1 standard steroid injection.
Intervention: Bupivacaine (Drug)
Group 2 (PNS therapy plus 1 standard steroid injection).
Participants will receive PNS therapy plus 1 standard steroid injection.
Intervention: Triamcinolone (Drug)
Group 2 (PNS therapy plus 1 standard steroid injection).
Participants will receive PNS therapy plus 1 standard steroid injection.
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
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
No secondary outcomes reported