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Osteoarthritis, KneeNCT05050396

Radiofrequency Ablation on Pain Relief of Knee Osteoarthritis

A study testing Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis in people with Osteoarthritis, Knee, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction Osteoarthritis (OA) is a chronic, progressive disease with high disability and teratogenicity in the joints. Deterioration of the articular cartilage is the main problem associated with osteoarthritis, which decreases joint space between the two bones[1]. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with intractable knee pain intensity >5 on an 11-point visual analog scale (VAS) (where 0=no pain and 10=worst pain imaginable) for longer than three months and unable to do knee replacement surgery.
  • Age > 50 years.
  • Grade 2 or 3 KOA based on the Kellgren-Lawrence classification.
  • Patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months.
  • Duration of knee pain ≥ 3 months.
  • Numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.

Who cannot join

  • Grade 1 or 4 KOA based on the Kellgren-Lawrence classification.
  • Severe liver, kidney, cardiovascular, and respiratory disease.
  • Abnormal blood coagulation.
  • Skin infections in the puncture region.
  • Patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF.
  • Mental disorders or inability to complete the follow-up observational form.

Trial locations and contacts

No sites are listed yet.

Saif eldeen SE Gamal, Master contact

+20 103 389 3202

saifeldeen616@gmail.com

Mohamed Mb Hassan Bakri, Professor contact

+20 106 635 6375

mhbakri@aun.edu.eg

About this study

Official title: Comparison of The Effect of Cooled Versus Thermocoagulant Radiofrequency Ablation on Pain Relief of Knee Osteoarthritis

Introduction

Osteoarthritis (OA) is a chronic, progressive disease with high disability and teratogenicity in the joints. Deterioration of the articular cartilage is the main problem associated with osteoarthritis, which decreases joint space between the two bones[1].

Read more

Clinically, patients with knee OA typically present with a chief complaint of pain, often associated with limited range of motion, stiffness, osteophytes, crepitus, and effusions. Due to the progressive degenerative nature of OA and the associated pain, patients become more physically impaired through the course of the disease [6].

One of the main tissues affected by this disease is the articular cartilage, which is a thin tissue covering the bony end in the joint that mainly provides mechanical support and lubrication during joint movement [7].

Age, previous knee injuries, but also obesity(increased body mass index(BMI)) ,joint malalignment and instability that result in increased mechanical stress are all strong risk factors for the development of knee OA [8-10].

Magnetic resonance imaging (MRI), arthroscopy examination, high-frequency color ultrasound and thermal texture maps are the four most acceptable types of imaging examinations. These examinations cannot only help diagnose KOA, but they can also assess the severity of joint damage and evaluate disease progression and treatment [11,12].

Treatment options for patients with OA include: conservative approaches, such as weight loss, physical therapy, and pharmacological interventions, while the more invasive approaches include intraarticular injections, joint preserving surgical treatment, and total knee arthroplasty (TKA). [13, 14] Radiofrequency ablation (RFA) is a novel technique that also recently gained popularity in alleviating chronic pain in patients with musculoskeletal disorders such as OA [15] Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). [16, 17]

Read the detailed description

Introduction

Osteoarthritis (OA) is a chronic, progressive disease with high disability and teratogenicity in the joints. Deterioration of the articular cartilage is the main problem associated with osteoarthritis, which decreases joint space between the two bones[1].

Because of the higher prevalence of asymptomatic OA, it is approximated that 250 million people all over the world suffer from OA [2,3].

The prevalence of knee OA increased significantly over the last decades and continues to rise, partially because of the increasing prevalence of obesity and other risk factors, [4].

It is estimated that the prevalence of knee OA among adults 60 years of age or older is approximately 10% in men and 13% in women [5].

Clinically, patients with knee OA typically present with a chief complaint of pain, often associated with limited range of motion, stiffness, osteophytes, crepitus, and effusions. Due to the progressive degenerative nature of OA and the associated pain, patients become more physically impaired through the course of the disease [6].

One of the main tissues affected by this disease is the articular cartilage, which is a thin tissue covering the bony end in the joint that mainly provides mechanical support and lubrication during joint movement [7].

Age, previous knee injuries, but also obesity(increased body mass index(BMI)) ,joint malalignment and instability that result in increased mechanical stress are all strong risk factors for the development of knee OA [8-10].

Magnetic resonance imaging (MRI), arthroscopy examination, high-frequency color ultrasound and thermal texture maps are the four most acceptable types of imaging examinations. These examinations cannot only help diagnose KOA, but they can also assess the severity of joint damage and evaluate disease progression and treatment [11,12].

Treatment options for patients with OA include: conservative approaches, such as weight loss, physical therapy, and pharmacological interventions, while the more invasive approaches include intraarticular injections, joint preserving surgical treatment, and total knee arthroplasty (TKA). [13, 14] Radiofrequency ablation (RFA) is a novel technique that also recently gained popularity in alleviating chronic pain in patients with musculoskeletal disorders such as OA [15] Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). [16, 17] In the case of knee OA, RFA was first introduced in 2010 by Choi et al and further explored in subsequent years [18,19] The mechanism of action of the therapy is that the RF lesion is believed to stop nociceptive (A-δ and C-fibers) pain input from the periphery to the central nervous system without destroying the motor or sensory (A-β) fibers. [15] More specifically, the postulated mechanism of action for clinical benefit of RFA involves the heat generation resulting in thermocoagulation and localized neuronal tissue destruction. These lesions have been shown to demonstrate the characteristics of scar formation, including an acute inflammatory response, cell necrosis, and fibrosis with collagen fiber deposition, occurring over 3 weeks following the procedure. It has been shown that the basal lamina of Schwann cells may be preserved after RFA, which would allow nerve regeneration. The threshold for neuronal tissue destruction has been shown to be 45°C in several studies . [15,24,25] Additionally, RFA produces a local electrical field, which is thought to promote neuromodulation by inhibition of the excitatory c-fibers. [25,26]

Similar to conventional RFA, water-cooled radiofrequency (CRF) ablation is a novel technology that utilizes thermal ablative mechanisms; however, CRF gives the ability to create a greater local neuronal lesion to increase the changes of effective denervation [20] In CRF, water circulates inside the probe to remove heat, modulating the thermal heat in the tissue to around 60°C, and alters the overall size, shape, and projections of lesions compared to conventional RFA. It is postulated that the greater sized CRF lesions may reduce the number of technical failures in the setting of a complex and variable neuronal innervation to the knee. The ability to target a greater amount of neuronal tissue is believed to produce long-term pain relief at least to the duration of relief produced by conventional RFA [27] A key limitation regarding standard RF techniques relates to the charring of tissues at the electrode interface. [28,29] Extended periods of ionic heating will cause desiccation and subsequent charring of the tissues immediately adjacent to the probe, as this tissue is absorbing the highest concentration of energy. Once the tissue becomes charred, it acts as a significant insulator, preventing any subsequent energy moving beyond the charred tissue, limiting the size of lesions when standard RF technology is used Because of the size and shape limitations associated with standard RF ablation, it can be difficult to reach the desired nerve target [30] In order to overcome the charring and subsequent insulation associated with standard RF, cooled radiofrequency probes were developed, whereby cooled water is circulated through the probe tip to maintain lower temperatures at the tissue-tip interface.

The circulated water serves to carry the heat away from the tissue-tip interface, which will reduce the desiccation and subsequent charring of adjacent tissues. As such, CRFA is able to deliver more energy to the surrounding tissues, creating a larger area where ionic heating can occur.

Relevant Anatomy Neuronal innervation of the knee is substantially intricate. The knee is innervated by the articular branches, known as the genicular nerves, of several major nerves, including the femoral, tibial, common peroneal (fibular), saphenous, and obturator nerves [21, 22] More specifically, the tibial nerve provides branches that innervate the articular capsule as they follow the superior medial and superior lateral vascular supplies [22,23] In the same way, the common peroneal nerve provides 2 articular branches that innervate the inferolateral articular capsule, while another common peroneal branch innervates the anterolateral as it follows the interior lateral genicular vasculature [22, 23] Thus, RFA requires identification of anatomical landmarks around the knee to locate the various genicular nerve branches that innervate the joint. As a result, the superomedial, superolateral, and inferomedial genicular nerve branches are commonly targeted by their proximal relation to bony landmarks . [18, 23]

Being tested
Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritisProcedure or surgery

    Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). [16, 17] Similar to conventional RFA, water-cooled radiofrequency (CRF) ablation is a novel technology that utilizes thermal ablative mechanisms; however, CRF gives the ability to create a greater local neuronal lesion to increase the changes of effective denervation [20]

Study groups in NCT05050396
Study groupRoleWhat they receive
Cooled radio frequencyExperimentalIn CRF, water circulates inside the probe to remove heat, modulating the thermal heat in the tissue to around 60°C, and alters the overall size, shape, and projections of lesions compared to conventional RFA. It is postulated that the greater sized CRF lesions may reduce the number of technical failures in the setting of a complex and variable neuronal innervation to the knee. The ability to target a greater amount of neuronal tissue is believed to produce long-term pain relief at least to the duration of relief produced by conventional RFA [27]
Receives: Procedure: Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis
Thermocoagulant radio frequencyExperimentalConventional radiofrequency Ablation RFA of the knee can be performed under fluoroscopic, or other imaging, guidance, with a cannula advanced into the joint towards the area connecting the shaft to the epicondyle. The area is stimulated to identify the nerve position and to ensure that no motor nerves are activated, as evidenced by absence of fasciculations. The RF electrode is then advanced through the cannula to the target area [18] The electrode tip heats up targeted local tissue within a few millimeters to a temperature typically greater than 47°C (ranging from 70°C to 90°C) for 120 130 seconds, generated through an electromagnetic field with a frequency of 250 kHz . [15,18] The ablative heat is provided via flow of electrical current, generating a well-delineated lesion [24]
Receives: Procedure: Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.

    The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.

    Measured: 24weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05050396
Sponsor's protocol ID
Pain relief of osteoarthritis
Status last verified
Jun 2021
First submitted
10 Sep 2021
Last updated
20 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis in people with Osteoarthritis, Knee, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Saif eldeen SE Gamal, Master (+20 103 389 3202, saifeldeen616@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks. (time frame: 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

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