Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05050396 |
| Other study ID # |
Pain relief of osteoarthritis |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
Assiut University |
| Contact |
Saif eldeen SE Gamal, Master |
| Phone |
+20 103 389 3202 |
| Email |
saifeldeen616[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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].
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]
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]
