ACTIVE_NOT_RECRUITING

Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Conditions

Knee Osteoarthritis Knee Pain Chronic Knee Arthritis Knee Arthropathy Dorsal Root Ganglion Stimulation knee pain osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Dorsal root ganglion stimulation (DRG-S) may be able to treat mechanical pain caused by tissue injury or damage such as trauma or arthritis in addition to pain caused by nerve dysfunction or injury. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.

Official Title

Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee

Quick Facts

Study Start:2022-01-01

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05103527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age \>= 21 years old * Able to provide informed consent * Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities * Current pain score on visual analog scale (VAS) intensity ≥60 mm * One of two groups: 1) Non-operated knee pain patients who want to pursue alternative therapies and delay surgery or are not candidates for knee arthroplasty based on age, frailty, non-operable condition, or poor outcome with other side arthroplasty, or 2) Post traumatic knee pain patients with history of surgical repair (such as meniscal or ligament repair). * Radiologic confirmation (x-ray/MRI/CT) of Kellgren-Lawrence OA grade of 2 (mild) or 3 (moderate) or 4 (severe) noted within 6 months for the index knee * Continued pain in the target knee despite at least 3 months of conservative treatments with documented failure of physical therapy and standard conservative therapy, including trials of at least two different classes of analgesic medication * Failure of one or more prior interventional pain procedures such intraarticular corticosteroid or hyaluronidase knee injections, cooled radiofrequency ablation therapy, or regenerative medicine or prior surgery of the knee	* Non-English speaking * Douleur neuropathique 4 (DN4) score ≥4 * Receiving opioid analgesic medication at a dose of ≥90 mg oral morphine equivalents * Workers' compensation or no-fault insurance * Signs or symptoms of active infection in the index knee joint * Pregnancy * BMI \>45 * Presence of any contraindication for DRG stimulation, including neurological, medical, psychiatric, or social conditions. * Widespread pain conditions like fibromyalgia * Autoimmune/Inflammatory arthritic conditions such as Rheumatoid and psoriatic arthritis and other allied disorders (sjogren, felty, inflammatory bowl disease etc) * Collagen diseases (systemic lupus erythematosus, Scleroderma, etc) * Infectious arthritis * Evidence of prespecified joint safety conditions (eg, rapidly progressive OA, subchondral insufficiency fracture, osteonecrosis, pathologic fracture) in the index knee on screening radiographs * Scheduled for or anticipating any surgery during the trial period

Inclusion Criteria

Exclusion Criteria

* Age \>= 21 years old
* Able to provide informed consent
* Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities
* Current pain score on visual analog scale (VAS) intensity ≥60 mm
* One of two groups: 1) Non-operated knee pain patients who want to pursue alternative therapies and delay surgery or are not candidates for knee arthroplasty based on age, frailty, non-operable condition, or poor outcome with other side arthroplasty, or 2) Post traumatic knee pain patients with history of surgical repair (such as meniscal or ligament repair).
* Radiologic confirmation (x-ray/MRI/CT) of Kellgren-Lawrence OA grade of 2 (mild) or 3 (moderate) or 4 (severe) noted within 6 months for the index knee
* Continued pain in the target knee despite at least 3 months of conservative treatments with documented failure of physical therapy and standard conservative therapy, including trials of at least two different classes of analgesic medication
* Failure of one or more prior interventional pain procedures such intraarticular corticosteroid or hyaluronidase knee injections, cooled radiofrequency ablation therapy, or regenerative medicine or prior surgery of the knee

* Non-English speaking
* Douleur neuropathique 4 (DN4) score ≥4
* Receiving opioid analgesic medication at a dose of ≥90 mg oral morphine equivalents
* Workers' compensation or no-fault insurance
* Signs or symptoms of active infection in the index knee joint
* Pregnancy
* BMI \>45
* Presence of any contraindication for DRG stimulation, including neurological, medical, psychiatric, or social conditions.
* Widespread pain conditions like fibromyalgia
* Autoimmune/Inflammatory arthritic conditions such as Rheumatoid and psoriatic arthritis and other allied disorders (sjogren, felty, inflammatory bowl disease etc)
* Collagen diseases (systemic lupus erythematosus, Scleroderma, etc)
* Infectious arthritis
* Evidence of prespecified joint safety conditions (eg, rapidly progressive OA, subchondral insufficiency fracture, osteonecrosis, pathologic fracture) in the index knee on screening radiographs
* Scheduled for or anticipating any surgery during the trial period

Contacts and Locations

Study Locations (Sites)

The Spine and Pain Institute of New York

New York, New York, 10305

United States

Collaborators and Investigators

Sponsor: Kenneth B Chapman

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-01

Study Completion Date2026-05

Study Record Updates

Study Start Date2022-01-01

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Dorsal Root Ganglion Stimulation
knee pain
knee arthritis
osteoarthritis

Additional Relevant MeSH Terms

Knee Osteoarthritis
Knee Pain Chronic
Knee Arthritis
Knee Arthropathy