What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as radiofrequency ablation (RFA) and steroid injections, have known side effects. RFA can cause increased pain, transient lower limb numbness, paraesthesias, and superficial burns. Steroid injections may lead to local pain, bleeding, tenderness, swelling, bruising, and a risk of local infection. While these treatments can provide pain relief, their benefits are often short-term, and the procedures carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis that focus on reducing pain and inflammation. Steroid injections, such as triamcinolone acetonide and methylprednisolone, are commonly used to manage inflammation and pain in osteoarthritis. While radiofrequency ablation (RFA) itself is not specifically approved for osteoarthritis, it is used off-label for pain management in conditions like chronic low back pain and has shown some benefit in clinical trials for joint pain. The combination of RFA and steroid injections aims to provide longer-lasting pain relief by disrupting nerve function and reducing inflammation.

What other types of research exist?

Promising novel alternatives to Radiofrequency Ablation plus Steroid Injections for Osteoarthritis patients include: 1) Pulsed Radiofrequency (PRF) treatment of the saphenous nerve, which has shown effectiveness in reducing knee OA-associated pain for at least 12 weeks without adverse events. 2) Intraarticular injection of sprifermin (rhFG-18), a recombinant human fibroblast growth factor, which has been associated with increased cartilage thickness, although its clinical relevance is still being studied. 3) Investigational treatments targeting matrix metalloproteinases (MMPs) and aggrecanases, which are involved in cartilage degradation, though these are still in early stages of research.

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Corticosteroid

Radiofrequency Ablation + Steroids for Knee and Hip Osteoarthritis

N/A

Recruiting

Led By Avneesh Chhabra, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post procedure

Awards & highlights

Summary

This trial is testing if combining radiofrequency ablation with steroid injections offers better and longer-lasting pain relief for knee or hip osteoarthritis patients compared to just using steroid injections. The study involves 80 patients who will be assessed for pain and function over a period of time. Radiofrequency ablation has been shown to be effective in reducing pain and improving function in knee osteoarthritis patients.

Who is the study for?

This trial is for adults aged 18 to 100 with advanced osteoarthritis in the knee (Kellgren-Lawrence grade 3-4) or hip (Tonnis grades 2 or higher). It's not for those who've had a knee or hip replacement, recent steroid injections within the last six weeks, or have an active infection.

What is being tested?

The study is testing if using radiofrequency ablation (RFA) with steroids provides better pain relief and improved function than just steroids alone in patients with severe knee and hip osteoarthritis. Participants will be randomly assigned to one of two groups and followed up at several time points after treatment.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, possible nerve damage from RFA, allergic reactions to steroids, temporary increase in pain post-procedure, and rare risks associated with any invasive procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hip Functional score at 2 weeks post procedure

Hip Functional score at 3 months post procedure

Hip Functional score at 6 months post procedure

+5 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT02821754

97%

Lymphocyte count decreased

89%

Anemia

86%

Aspartate aminotransferase increased

83%

Hyponatremia

78%

Hypoalbuminemia

72%

Alkaline phosphatase increased

69%

Platelet count decreased

67%

Alanine aminotransferase increased

58%

Fatigue

58%

Serum amylase increased

56%

Pain

53%

White blood cell decreased

53%

Hypophosphatemia

50%

Constipation

47%

Activated partial thromboplastin time prolonged

44%

Abdominal pain

44%

Creatinine increased

42%

Rash maculo-papular

42%

Nausea

39%

Blood bilirubin increased

36%

Hyperglycemia

36%

Pruritus

31%

Bloating

31%

Hypercalcemia

31%

Hypokalemia

31%

Fever

28%

Vomiting

28%

Edema limbs

25%

Diarrhea

25%

Hypermagnesemia

22%

Hyperkalemia

22%

Dry mouth

22%

Insomnia

22%

Cough

19%

Anorexia

19%

Hyperuricemia

19%

Dry skin

19%

Dyspnea

19%

Headache

19%

Hypomagnesemia

17%

Hypernatremia

17%

Neutrophil count decreased

17%

Back pain

14%

Dehydration

14%

Generalized muscle weakness

14%

Hypocalcemia

11%

Chills

11%

Skin hyperpigmentation

11%

Urinary retention

11%

Weight loss

11%

Abdominal distension

11%

Ascites

11%

Dizziness

11%

Dyspepsia

11%

Lipase increased

11%

Pain in extremity

11%

Skin and subcutaneous tissue disorders - Other, Itching

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death

Hypertension

Non-cardiac chest pain

Paresthesia

Hypothyroidism

Mucositis oral

Bone pain

Fibrinogen decreased

Depression

Encephalopathy

Infections and infestations - Other, severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)

Autoimmune disorder

Respiratory failure

Acute kidney injury

Blurred vision

CPK increased

Hypotension

INR increased

Investigations - Other, Elevated TSH

Pleural effusion

Sore throat

Urinary tract infection

Arthralgia

Colitis

Flank pain

Hematuria

Hot flashes

Hypoglycemia

Sinus bradycardia

Sinus tachycardia

Skin infection

Atrial fibrillation

Confusion

Skin and subcutaneous tissue disorders - Other, Plaque rash

Delirium

Myositis

Depressed level of consciousness

Gastrointestinal disorders - Other, Abdominal fullness

Glaucoma

Rash acneiform

Hepatic hemorrhage

Anaphylaxis

Jejunal perforation

Lung infection

Nasal congestion

Gastritis

Infections and infestations - Other, Cellulitis - infection left upper extremity

Musculoskeletal and connective tissue disorder - Other, Myasthenia Gravis

Arthritis

Cataract

Chest wall pain

Dysphagia

Erectile dysfunction

Eye disorders - Other, Eye itching

Facial nerve disorder

Fall

Hyperhidrosis

Hypoxia

Infections and infestations - Other, Tinea cruris

Nervous system disorders - Other, Tongue numbness

Papulopustular rash

Pelvic pain

Peripheral sensory neuropathy

Pneumonitis

Pneumothorax

Respiratory, thoracic and mediastinal disorders - Other, Pulmonary abnormalities

Skin and subcutaneous tissue disorders - Other, Cracked skin

Skin and subcutaneous tissue disorders - Other, Dermatitis - right buttocks

Skin and subcutaneous tissue disorders - Other, Face swelling

Skin and subcutaneous tissue disorders - Other, Itching arm and chest

Skin and subcutaneous tissue disorders - Other, Psoriasis; lower back

Skin and subcutaneous tissue disorders - Other, Skin discoloration

Skin and subcutaneous tissue disorders - Other, Swelling - left leg

Skin and subcutaneous tissue disorders - Other, swelling- feet/legs

Somnolence

Upper respiratory infection

Urinary frequency

Urinary incontinence

Watering eyes

Bullous dermatitis

Stroke

Acidosis

Bruising

Dry eye

Erythema multiforme

Esophageal varices hemorrhage

Eye disorders - Other, Eye irritation

Fracture

Gastroesophageal reflux disease

Gastrointestinal disorders - Other, Bloating

Gastrointestinal disorders - Other, Epigastric pain

General disorders and administration site conditions - Other, Numbness - left hand

Hematoma

Hemorrhoids

Hyperthyroidism

Immune system disorders - Other, Allergy development

Immune system disorders - Other, Skin rash near anus/groin

Infections and infestations - Other, Headaches and nose bleeds

Infections and infestations - Other, Staph

Infections and infestations - Other, Thrush

Lethargy

Localized edema

Musculoskeletal and connective tissue disorder - Other, Leg cramps

Myalgia

Skin and subcutaneous tissue disorders - Other, Keratosis; frontal scalp

Skin and subcutaneous tissue disorders - Other, Mild rash on shoulder and sparsely on back

Skin and subcutaneous tissue disorders - Other, Wound to gluteal folds

Skin and subcutaneous tissue disorders - Other, itching-anus

Skin and subcutaneous tissue disorders - Other, swelling- ankle

Skin hypopigmentation

Allergic reaction

Allergic rhinitis

Blood and lymphatic system disorders - Other, aPTT decreased

Gastrointestinal disorders - Other, Indigestion

Gastroparesis

Memory impairment

Pharyngolaryngeal pain

Skin and subcutaneous tissue disorders - Other, Abrasion on forehead

Skin and subcutaneous tissue disorders - Other, Brown lesion/rash

Skin and subcutaneous tissue disorders - Other, Dermatitis - penis

Skin and subcutaneous tissue disorders - Other, specify

Skin and subcutaneous tissue disorders - Other, Redness to radiation area

Wheezing

Ileal obstruction

Immune system disorders - Other, Skin rash near anus

100%

80%

60%

40%

20%

Study treatment Arm

Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)

Radiofrequency Ablation/Cryoablation (RFA/CA)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perineural Steroid Injections Plus Radiofrequency AblationExperimental Treatment2 Interventions

Participants assigned to this study arm will receive Perineural Steroid Injections plus Radiofrequency Ablation per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.

Group II: Perineural Steroid Injections AloneActive Control1 Intervention

Participants assigned to this study arm will receive only Perineural Steroid Injections per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiofrequency Ablation (RFA)

2016

Completed Phase 2

~130

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include Radiofrequency Ablation (RFA) and steroid injections, which are particularly relevant for patients with advanced OA. RFA disrupts nerve function, thereby reducing pain by preventing pain signals from reaching the brain. Steroid injections reduce inflammation and pain by inhibiting inflammatory pathways. Nonsteroidal anti-inflammatory drugs (NSAIDs) also reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Physical therapy aims to improve joint function and reduce pain through targeted exercises and strengthening. Understanding these mechanisms is crucial for OA patients as it helps them and their doctors choose the most appropriate treatment based on the specific symptoms and severity of their condition.