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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06004882
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 29.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nerve Stimulation; Genicular Nerves; Chronic Knee Pain	Other: PNS therapy; Drug: Triamcinolone; Drug: Bupivacaine; Other: Placebo	N/A

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
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study
• Actual Study Start Date: Aug 10, 2023
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Saba Javed, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT06004882
• Other Study ID Numbers: 2023-0041; NCI-2023-06513
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Triamcinolone; Bupivacaine

Study Results

No Results Posted as of Aug 22, 2023