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Chronic Ankle Pain in AthletesNCT07778589

Comparison Between Radiofrequency,Hydrodissection and Cryoneurolysis in Chronic Ankle Pain

A study testing Radiofrequency ablation, Hydrodissectipn with botilonum toxin and Cryoneurolysis in people with Chronic Ankle Pain in Athletes, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Chronic Ankle Pain in Athletes
What is being tested?
Radiofrequency ablation, Hydrodissectipn with botilonum toxin and Cryoneurolysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
No sites listed yet
Study dates
20 Oct 2026to 20 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Read more

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.

Being tested
Radiofrequency ablation, Hydrodissectipn with botilonum toxin, Cryoneurolysis

What participants receive

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

  • Radiofrequency ablationProcedure or surgery

    Conventional radiofrequency ablation of superfiacial peroneal nerve

  • Hydrodissectipn with botilonum toxinProcedure or surgery

    Hydrodissection of superficial peroneal nerve by botolinum toxin

  • CryoneurolysisProcedure or surgery

    Cryoneurolysis by carbon dioxide of superfial peroneal nerve

Study groups in NCT07778589
Study groupRoleWhat they receive
Group 1Active comparatorRadiofrequency ablation of superficial peroneal nerve
Receives: Procedure: Radiofrequency ablation
Group 2Active comparatorHydrodissection with botulinum of superficial peroneal nerve
Receives: Procedure: Hydrodissectipn with botilonum toxin
Group 3Active comparatorCryoneurolysis of superficial peroneal nerve
Receives: Procedure: Cryoneurolysis

What is being measured

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

  1. Pain intensity measured by Visual Analog Scale (VAS)

    Measured: 6months

Timeline

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

  1. First posted21 Aug 2026
  2. Study start20 Oct 2026 (estimated)
  3. Primary completion20 Oct 2029 (estimated)
  4. Study completion20 Dec 2029 (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
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07778589
Sponsor's protocol ID
Neuromodulation in ankle pain
Status last verified
Aug 2026
First submitted
18 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation, Hydrodissectipn with botilonum toxin and Cryoneurolysis in people with Chronic Ankle Pain in Athletes, 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity measured by Visual Analog Scale (VAS) (time frame: 6months). 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 21 Aug 2026.

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