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

NCT06710782 | Completed

• 1 other identifier: 36264MS262/7/23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous; Pulsed Radiofrequency; Genicular Nerve Block; Intraarticular; Hyaluronic Acid; Chronic Pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  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."

  3 month after injection

Secondary Outcomes (4)

• Functional status

  3 month after injection

• Daily activity

  3 month after injection

• Analgesic requirement

  3 month after injection

• Adverse events

  3 month after injection

Study Arms (2)

Hyaluronic Acid group

EXPERIMENTAL

Patients underwent intra-articular hyaluronic acid injection.

Drug: Hyaluronic acid

Transcutaneous pulsed radiofrequency group

EXPERIMENTAL

Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.

Device: Transcutaneous pulsed radiofrequency

Interventions

Hyaluronic acid DRUG

Patients underwent intra-articular hyaluronic acid injection.

Hyaluronic Acid group

Transcutaneous pulsed radiofrequency DEVICE

Patients underwent transcutaneous pulsed radiofrequency application plus genicular nerve block.

Transcutaneous pulsed radiofrequency group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology,Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author.

Locations

EG (1)