Transcutaneous Pulsed Radiofrequency Application Plus Genicular Nerve Block Versus Intraarticular Hyaluronic Acid Injection for Management of Chronic Pain in Knee Osteoarthritis.

Not Applicable

Completed

• Conditions: Transcutaneous; Pulsed Radiofrequency; Genicular Nerve Block; Intraarticular; Hyaluronic Acid; Chronic Pain; Knee Osteoarthritis
• Interventions: Drug: Hyaluronic acid; Device: Transcutaneous pulsed radiofrequency

• Registration Number: NCT06710782
• Lead Sponsor: Tanta University

Brief Summary

The aim of the present study is to compare the analgesic efficacy of combined transcutaneous pulsed radiofrequency plus genicular nerve block with bupivacaine plus corticosteroid versus intraarticular Hyaluronic acid injections, in terms of clinical and functional parameters, in patients with knee osteoarthritis.

Detailed Description

Total knee arthroplasty is commonly used as a surgical option for the treatment of symptomatic knee osteoarthritis to relieve pain and improve function, although it is associated with increased perioperative morbidity and mortality, particularly in older patients with co morbidities. Despite high success rates after total knee arthroplasty , a significant number of patients report suffering from postoperative pain, which can be worse than reported preoperative pain.

As an alternative approach, radiofrequency treatment modalities on the knee joint have been used to reduce knee pain due to osteoarthritis. Genicular nerve block (GNB) is a recently developed therapeutic option for knee osteoarthritis. that targets the three sensory nerves of the knee: superior lateral, superior medial and inferior medial genicular nerve, to inhibit pain transmission to the central nervous system.

Early osteoarthritis. treatment combines non pharmacological techniques with oral pharmacological therapies, intraarticular injections (IAI) of hyaluronic acid (HA), corticosteroid with local anesthetic or platelet-rich plasma (PRP) are used in progressive or very symptomatic stage. Intraarticular injections (IAI) is considered one of first-line treatments in recent studies as it is effective in decreasing pain and safer than oral pharmacological therapies.

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Aged above 40 years.
• Both sexes
• American Society of Anesthesiologists (ASA)physical status I and II.
• Patients radiologically proven symptomatic knee joint osteoarthritis not responding to medical treatment.
• Patients with knee pain of moderate or greater intensity on most or all days for ≥ 3 months, showing significant radiological osteoarthritis (Kellgren-Lawrence grade 1 to 3).

Radiological severity was assessed using the Kellgrenand Lawrence global scale as follow: Grade 0; means absence of radiological finding; grade 1: suspected narrowing of joint space; grade 2 refers to osteophytes and possible narrowing; grade 3 is defined as multiple os-teophytes, definite narrowing of joint space and grade 4 comprises large osteophytes, marked narrowing of joint space.

Exclusion Criteria

• Patient refusal.
• Patients who show improvement on medical treatment, patients on an oral, topical, or intra-articular steroid during the 4 weeks before the study; patients with an oral, topical, or suppository non-steroidal anti-inflammatory drugs within 2 weeks before the study.
• Patients having secondary knee osteoarthritis.
• Patients with severe osteoarthritis.(K/L grade >3) in a location other than the knee joint.
• Patients with rheumatoid arthritis.
• Patients with joint replacement surgery in either knee and/or a hip.
• Patients with meniscal tear, ligament injury, bursitis, and popliteal cyst and blood investigations suggestive of any infection.
• Morbid obese patients (body mass index (BMI) of >40 kg/m2)
• Infection at site of injection.
• Bleeding diathesis and coagulopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid group	Hyaluronic acid	Patients underwent intra-articular hyaluronic acid injection.
Transcutaneous pulsed radiofrequency group	Transcutaneous pulsed radiofrequency	Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.

Primary Outcome Measures

Name	Time	Method
Degree of pain	3 month after injection	Assessment of pain severity by visual analog scale (VAS) at the baseline (before injection), 1month and 3month, intervals after injection.; The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain."

Secondary Outcome Measures

Name	Time	Method
Functional status	3 month after injection	Functional status and daily activity via the western ontario and mcmaster universities osteoartheritis index (WOMAC) score before one month and three monthes after injection.; The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Daily activity	3 month after injection	Daily activity via the western ontario and mcmaster universities osteoartheritis index (WOMAC) score before one month and three monthes after injection.; The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Analgesic requirement	3 month after injection	Analgesic requirement (Dose and frequency of oral acetaminophen intake) for post injection pain if visual analogue scale (VAS) more than 3.; Visual Analogue Scale (VAS) used as an effective tool to detect intensity of pain was recorded;"0" represents no pain,"10" worst pain, "1-3" mild pain,"4-6 " moderate pain and" 7-10 " severe pain
Adverse events	3 month after injection	Adverse events were recorded such as toxicity of local anesthetic drug occur, the research was stopped and was cleared to ehtical committees.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, ElGharbia, Egypt