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.
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.
- Conditions
- Chronic Ankle Pain in Athletes
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Radiofrequency ablation of superficial peroneal nerve Receives: Procedure: Radiofrequency ablation |
| Group 2 | Active comparator | Hydrodissection with botulinum of superficial peroneal nerve Receives: Procedure: Hydrodissectipn with botilonum toxin |
| Group 3 | Active comparator | Cryoneurolysis of superficial peroneal nerve Receives: Procedure: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted21 Aug 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2029 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Pain in AthletesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Maher, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07778589
- Acronym / sponsor ID
- Neuromodulation in ankle pain
- Conditions
- Chronic Ankle Pain in Athletes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2029 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Radiofrequency ablationRadiofrequency ablation of superficial peroneal nerve |
| Group 2 | Active comparator | Procedure: Hydrodissectipn with botilonum toxinHydrodissection with botulinum of superficial peroneal nerve |
| Group 3 | Active comparator | Procedure: CryoneurolysisCryoneurolysis of superficial peroneal nerve |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationConventional radiofrequency ablation of superfiacial peroneal nerve | Procedure or surgery | Group 1 |
| Hydrodissectipn with botilonum toxinHydrodissection of superficial peroneal nerve by botolinum toxin | Procedure or surgery | Group 2 |
| CryoneurolysisCryoneurolysis by carbon dioxide of superfial peroneal nerve | Procedure or surgery | Group 3 |
Primary outcome
Pain intensity measured by Visual Analog Scale (VAS)
Time frame: 6months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.