# Longterm Effect Of Genicular Nerve Ablation on Knee Pain, Gait and Joint Structure

> **NIH NIH R34** · TUFTS MEDICAL CENTER · 2020 · $324,447

## Abstract

ABSTRACT
Symptomatic knee osteoarthritis (OA) affects more than 10 million individuals in the United States and is a leading cause
of disability and medical costs. However, there is now a critical shortage of treatment options for people with KOA
because comorbidities that complicate treatment selection are highly prevalent in this population.
Recent studies indicate that blockade of the genicular nerve may be efficacious for OA knee pain, with benefit of 3
months or more. This treatment could theoretically be very helpful in managing knee OA pain in selected patients.
However, those studies were limited by methodologic issues (e.g. small size, short duration),most omitted objective
outcome measures, and only two used a sham control. It is also unclear whether the widely-used ‘prognostic’ block has
clinical utility. While all reported favorable safety, adverse event reporting was generally non-systematic and, in
particular, did not evaluate for longer term structural consequences in the knee. The latter is of concern because of the
well-known precedent of neuropathic arthritis. Therefore, there is a need to better understand the biomechanical
implications of sensory nerve blockade around a knee and the short- and long-term effects on articular structures.
Understanding these aspects will predicate development of a risk mitigation strategy while preserving the therapeutic
benefit of RFA.
The goal of this R34 is to complete logistical preparation for a one-year sham-controlled, randomized controlled trial
(RCT) of RFA for KOA assessing PROs including average daily pain (primary), patient-acceptable symptom state,
treatment failure; objective measurement of physical function, activity, proprioception, joint loading using gait analysis
and mobile devices, and knee structure using MRI. The primary endpoint will be at 3-months, with secondary endpoints
at 6, 9 and 12 months. Planning activities will include deciding between two compelling candidate designs, which allow
testing of the value of the ‘prognostic block’: “Efficacy And Effectiveness Too” (EE2) versus Factorial design. Additional
unique aspects will include analyses of biologically-relevant variables (sex, widespread pain, unilateral versus bilateral
KOA).
We will utilize stakeholder and scientific advisory committees to evaluate the relative merits and feasibility of the
candidate RCT designs, plan the study interventions, define outcome measures and targets, and finalize sample size
projections and analytic plan. We will write the consent materials, and obtain ethical and regulatory approval. We will
construct electronic source documents and a data capture system (REDCap) with query and reporting functions. We will
assemble the teams and collaborations necessary to administer the interventions, conduct trial activities, monitor data
quality and safety, putting in place subcontracts where appropriate. We will finalize development of a mobile
application for frequent collection of patient-cen...

## Key facts

- **NIH application ID:** 10049465
- **Project number:** 1R34AR076625-01A1
- **Recipient organization:** TUFTS MEDICAL CENTER
- **Principal Investigator:** Timothy E McAlindon
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $324,447
- **Award type:** 1
- **Project period:** 2020-08-15 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10049465

## Citation

> US National Institutes of Health, RePORTER application 10049465, Longterm Effect Of Genicular Nerve Ablation on Knee Pain, Gait and Joint Structure (1R34AR076625-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10049465. Licensed CC0.

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