- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07778589
Comparison Between Radiofrequency,Hydrodissection and Cryoneurolysis in Chronic Ankle Pain
Analgesic Efficacy of Radiofrequency Versus Hydrodissection or Cryoneurolysis of the Superficial Peroneal Nerve in Chronic Ankle Pain Following Anterior Talofibular Ligament Injury in Athletes: A Randomized Comparative Trial
Ligamentous injuries of the ankle are common among athletes. Inversion injuries of the ankle account for 40% of all athletic injuries. The anterior talofibular ligament (ATFL) and the calcaneofibular ligament (CFL) are sequentially the most commonly injured ligaments when a plantar-flexed foot is forcefully inverted. The posterior talofibular ligament (PTFL) is rarely injured, except in association with a complete dislocation of the talus.
Eighty percent of patients with lateral ankle injuries make a full recovery following conservative rehabilitation.
Up to 20% of patients with an acute inversion injury develop chronic functional instability. Electromyography (EMG) has demonstrated prolonged reaction times of the peroneal muscle in this group of patients. Strengthening and proprioception exercises can lead to improvement. Patients whose injury does not respond and who have continued mechanical laxity and functional instability may be candidates for lateral ligament reconstruction Chronic pain of the lower extremity remains challenging to manage.Non-Surgical Treatments include
- Physical therapy: Do strength, flexibility, and balance exercises to build support around the joint.
- Bracing and support: Wear an ankle brace or use custom shoe inserts (orthotics) to stabilize your foot.
- Activity changes: Swap high-impact sports like running for low-impact options like swimming or cycling.
- Medications: Take nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen to manage swelling and pain.
- Injections: Get targeted corticosteroid or regenerative injections if recommended by a doctor.
- Neuromodulaion : RFA, Cryneurolysis, botulinum injection Hydrodissection with botulinum toxin Hydrodissection is a minimally-invasive procedure that involves injecting fluid into anatomic spaces to facilitate dissection and adhesiolysis during surgery as proposed by Graesser et al. in 2022. In the past decade, it has been applied to the management of nerve entrapments by injecting fluid around the nerve to create space and separate them from surrounding structures. Injectates used are either saline, corticosteroids, anesthetic,dextrose water, platelet-rich plasma,Botulinum or combinations of these injectates Radiofrequency ablation in chronic ankle pain The use of both PRF and CRF has been reported to be used for chronic ankle and foot pain.CRF works by applying an active electrode to heat-targeted neural tissue to temperatures of 60-80 °C. These high temperatures cause coagulative necrosis, collagen destruction, and axonal degeneration, thereby resulting in third- and fourth-degree peripheral nerve injury . Pain relief is limited however by progressive axonal regeneration . In contrast to CRF, PRF delivers high-frequency current in a pulsed manner, allowing time between pulses for the dissipation of produced heat. As such, the electrode tip is kept at a maximum of 42 °C, which is below the temperature that produces nerve damage. Instead, though it is not yet clarified, it is thought that PRF employs a strong electromagnetic field to functionally change neuronal cells in small unmyelinated and lightly myelinated nerve fibers selectively. This in effect causes disruption of neuronal membranes, modulation of neuronal gene expression, and modulation of neuronal local cytokine release .
Following treatment, immediate changes of endoneurial edema can be seen histologically and clinical pain relief may last several years Cryoneurolysis Cryoneurolysis, also known as cryoablation or cryoneuroablation, is the application of cold temperatures to targeted nerves to "freeze" them in an attempt to block pain signals . This technique was introduced to treat acute pain initially but has significantly gained interest as an intervention for those struggling with chronic pain conditions, primarily due to the failure of traditional interventions that resulted in temporary results and further complications. Evidence has shown that cryoneurolysis may offer long-term pain relief without the need for constant pharmaceutical interventions . It is for this reason that it represents a desirable therapeutic opportunity to consider for patients suffering from chronic knee pain, neuropathic pain, and post-surgery-related pain Owing to its minimally invasive/non-invasive nature and lasting pain relief over months, cryoneurolysis offers significant advantages over traditional pain management methods . Furthermore, cryoneurolysis does not have systemic effects or addiction risks, as seen in long-term opioid use, making it a better pain management option today in the context of the increasing opioid crisis
Aim of study:
To evaluate and compare the efficacy of three ultrasound-guided neuromodulation techniques-hydrodissection with botulinum toxin, conventional radiofrequency ablation (RFA), and cryoneurolysis-targeting the superficial fibular nerve (SFN) in athletes with chronic ankle pain after anterior talofibular ligament (ATFL) injuries.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Athletes aged 18-45 years
- Chronic ankle pain (>6 months) following ATFL injury
- Clinical and imaging confirmation of ATFL injury
- No surgical indication (complete tear, associated fracture)
- Failure of conservative treatment
Exclusion Criteria:
- Previous ankle surgery
- Peripheral neuropathy or systemic neurological disease
- Contraindications to botulinum toxin, RF ablation, or cryoneurolysis
- General exclusion criteria for intervention (local infection, coagulopathy, patient refusal)
- long standing condition >5 y
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Group 1
Radiofrequency ablation of superficial peroneal nerve
|
Conventional radiofrequency ablation of superfiacial peroneal nerve
|
|
Aktiver Komparator: Group 2
Hydrodissection with botulinum of superficial peroneal nerve
|
Hydrodissection of superficial peroneal nerve by botolinum toxin
|
|
Aktiver Komparator: Group 3
Cryoneurolysis of superficial peroneal nerve
|
Cryoneurolysis by carbon dioxide of superfial peroneal nerve
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Pain intensity measured by Visual Analog Scale (VAS)
Zeitfenster: 6months
|
6months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Neuromodulation in ankle pain
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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