Comparison Between Radiofrequency,Hydrodissection and Cryoneurolysis in Chronic Ankle Pain
NCT07778589 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2026-08-21
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. 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.
Conditions
- Chronic Ankle Pain in Athletes
Interventions
- PROCEDURE
-
Radiofrequency ablation
Conventional radiofrequency ablation of superfiacial peroneal nerve
- PROCEDURE
-
Hydrodissectipn with botilonum toxin
Hydrodissection of superficial peroneal nerve by botolinum toxin
- PROCEDURE
-
Cryoneurolysis
Cryoneurolysis by carbon dioxide of superfial peroneal nerve
Sponsors & Collaborators
-
Assiut University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-20
- Primary Completion
- 2029-10-20
- Completion
- 2029-12-20
More Related Trials
-
The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain
NCT01249573 ·Status: COMPLETED ·Phase: NA
-
Conventional MRI Versus MR Arthrography in Evaluation of Ankle Impingement Syndromes and Intra Articular Pathologies.
NCT03860922 ·Status: UNKNOWN
-
Video Aided Mindful Deep Breathing for Pain Management
NCT04812158 ·Status: COMPLETED ·Phase: NA
-
Validating the Speckle Tracking Methods on Soft Tissue Strain, Displacement, and Roles in Physical Therapy
NCT07485530 ·Status: RECRUITING ·Phase: NA
-
Comparison of The Acute Effects of Different Stretching Methods on Ankle Joint Range In Healty Older Adults
NCT05130372 ·Status: COMPLETED ·Phase: NA
-
Integrated Exercise Therapy Interventions on the Performance and Injury Prevention in Competitive Sports
NCT04384003 ·Status: UNKNOWN ·Phase: NA
-
Cryo-ultrasound Versus LASER Therapy on Ankle Sprain in Tennis Players
NCT06766318 ·Status: COMPLETED ·Phase: NA
-
Echoguided Percutaneous Neuromodulation in the Management of Chronic Ankle Instability in Physically Active Subjects.
NCT05942417 ·Status: COMPLETED ·Phase: NA
-
Neuromuscular Control of the Ankle With External Support
NCT01781351 ·Status: UNKNOWN ·Phase: NA
-
Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain
NCT04846712 ·Status: RECRUITING
-
Dynamic Ultrasound in Evaluation of Tendo-ligamentous Ankle Injury
NCT03621150 ·Status: UNKNOWN
-
Aspiration for Pain Relief Following Ankle Fracture
NCT01484535 ·Status: COMPLETED ·Phase: NA
-
The Acute Effect Comparisons of Manual Therapy Or Ankle Motion in Individuals Who Had Achilles Tendon Repair
NCT06112288 ·Status: RECRUITING ·Phase: NA
-
Validity and Reliability of Calf Raise Tests in Patients With Achilles Tendon Rupture and Lateral Ankle Sprain
NCT07197593 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability
NCT06945198 ·Status: RECRUITING ·Phase: NA
-
Chronic Ankle Instability, Surgical Repair: Open Versus Closed
NCT02998333 ·Status: COMPLETED ·Phase: NA
-
Correlation Between Acute Analgesia and Long-Term Function Following Ankle Injuries
NCT02667730 ·Status: COMPLETED ·Phase: PHASE4
-
Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability
NCT05815576 ·Status: COMPLETED ·Phase: NA
-
Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
NCT03750253 ·Status: UNKNOWN ·Phase: NA
-
Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains
NCT05920044 ·Status: UNKNOWN ·Phase: NA
-
To Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
NCT06826898 ·Status: RECRUITING ·Phase: NA
-
Impact of Hyperarch Fascia Training on Ankle Health and Exercise Performance
NCT06959472 ·Status: COMPLETED ·Phase: NA
-
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
NCT01117909 ·Status: UNKNOWN ·Phase: NA
-
Relevance of Osteochondral Lesions in Ankle Microinstability
NCT06947317 ·Status: COMPLETED ·Phase: NA
-
Acute Effect of Standardized Ankle Taping on Lower Limb Asymmetry During Countermovement Jump in Healthy Judokas
NCT07688330 ·Status: NOT_YET_RECRUITING ·Phase: NA