Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study

Purpose

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.

Conditions

  • Peripheral Nerve Stimulation
  • Genicular Nerves
  • Chronic Knee Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 (standard steroid injection) 		Participants will receive 1 standard steroid injection.
  • Drug: Triamcinolone
    Given by Injection
  • Drug: Bupivacaine
    Given by Injection
Experimental
Group 2 (PNS therapy plus 1 standard steroid injection). 		Participants will receive PNS therapy plus 1 standard steroid injection.
  • 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
Experimental
Group 3 (PNS therapy plus 1 placebo injection) 		Participants will receive PNS therapy plus 1 placebo injection.
  • 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
  • Other: Placebo
    Given by Injection

Recruiting Locations

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Saba Javed, MD
713-792-9530
sjaved@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Saba Javed, MD
(713) 792-9530
sjaved@mdanderson.org

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