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Comparison Between Radiofrequency,Hydrodissection and Cryoneurolysis in Chronic Ankle Pain

2026年8月18日 更新者:Hager Maher、Assiut University

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.

調査の概要

研究の種類

介入

入学 (推定)

87

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Group 1
Radiofrequency ablation of superficial peroneal nerve
Conventional radiofrequency ablation of superfiacial peroneal nerve
アクティブコンパレータ:Group 2
Hydrodissection with botulinum of superficial peroneal nerve
Hydrodissection of superficial peroneal nerve by botolinum toxin
アクティブコンパレータ:Group 3
Cryoneurolysis of superficial peroneal nerve
Cryoneurolysis by carbon dioxide of superfial peroneal nerve

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Pain intensity measured by Visual Analog Scale (VAS)
時間枠:6months
6months

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月20日

一次修了 (推定)

2029年10月20日

研究の完了 (推定)

2029年12月20日

試験登録日

最初に提出

2026年8月18日

QC基準を満たした最初の提出物

2026年8月18日

最初の投稿 (実際)

2026年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月18日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Neuromodulation in ankle pain

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米国FDA規制機器製品の研究

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