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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06004882
Status
Recruiting
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Conditions

  • Chronic Knee Pain
  • Genicular Nerves
  • Peripheral Nerve Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PNS therapy — OTHER
    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
  • Triamcinolone — DRUG
    Given by Injection
  • Bupivacaine — DRUG
    Given by Injection
  • Placebo — OTHER
    Given by Injection

Study Details

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.

Key Dates

Start date
Aug 10, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (standard steroid injection)
    Participants will receive 1 standard steroid injection.
  • Experimental: Group 2 (PNS therapy plus 1 standard steroid injection).
    Participants will receive PNS therapy plus 1 standard steroid injection.
  • Experimental: Group 3 (PNS therapy plus 1 placebo injection)
    Participants will receive PNS therapy plus 1 placebo injection.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Saba Javed, MD
[email protected]
713-792-9530
Saba Javed, MD (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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