The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

Study Overview
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Brief Summary
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Anterior talofibular ligament is the most injured ligament in ankle sprain. Investigators will include ankle sprain patients who have ankle pain or instability more than 3 months. Ultrasonography will be done for confirm ligament injury. Participants will be randomized into two groups. Participants in dextrose injection group will accept dextrose 15% injection to tendon and enthesis. In the other hand, subcutaneous sham injection to control group. Pain condition, stability test and function test, will be evaluated in 1 week, 4 weeks and 12 weeks after injection.

Detailed Description
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Background: Sprains constitute most of ankle injury and 85% ankle sprain is inversion injury. The conventional treatment includes medication, physical therapy, bracing and steroid injection. Anterior talofibular ligament is the most injured ligament in ankle sprain. Although the response of acute ligament sprain is usually quickly, treatment of chronic ligament sprain is difficult. Chronic pain and ankle instability is the most common symptom in chronic ankle sprain. Dextrose prolotherapies been used for treating soft tissue injury such as osteoarthritis, tendinopathy and ligament sprain. However, there is not randomized control trial for hypertonic dextrose injection to chronic ankle sprain. Methods: Investigators will include 40 ankle sprain patients who have ankle pain or instability sensation more than 3 months. Ultrasonography will be done for confirm ligament injury. Participants will be randomized into two groups. Dextrose injection group will accept dextrose 15% injection to tendon and enthesis. Otherwise, investigators will do subcutaneous sham injection to control group. Investigators will measure pain threshold and peak pressure by algometer, the degree of ankle instability by ultrasound, the proprioception by single leg standing, and foot and ankle questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.To our hypothesis, investigators suggest dextrose prolotherapy injection could decrease pain and improved proprioception.

Official Title
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The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain: A Randomized Controlled Trial

Conditions
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Ankle Sprains

Intervention / Treatment
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* Procedure: Sham injection
* Procedure: Tendon injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-70 age Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation Ultrasound diagnosed anterior talofibular ligament sprain Exclusion Criteria: Acute ankle sprain less than 3 months Lower limb fracture history Cognitive impairment Other neurological or muscular disorders Sever pain could not tolerate examination

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham injection<br>Dextrose water injection to subcutaneous layer at tender point | Procedure: Sham injection<br>* Dextrose water injection to subcutaneous layer at tender point<br>|
| Experimental: Tendon injection<br>Dextrose water injection to injured tendon | Procedure: Tendon injection<br>* Dextrose water injection to injured tendon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle pain | visual analogue scale(VAS), range 0-10, the higher scale the worsen pain | Change from baseline VAS at 1 week | 
| Ankle pain | visual analogue scale(VAS), range 0-10, the higher scale the worsen pain | Change from baseline VAS at 4 week | 
| Ankle pain | visual analogue scale(VAS), range 0-10, the higher scale the worsen pain | Change from baseline VAS at 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle proprioception | The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion | Change from baseline of difference of ankle degree at 1 week | 
| Ankle proprioception | The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion | Change from baseline of difference of ankle degree at 4 weeks | 
| Ankle proprioception | The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion | Change from baseline of difference of ankle degree at 12 weeks | 
| Ankle function | Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse | Change from baseline FADI at 1 week | 
| Ankle function | Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse | Change from baseline FADI at 4 weeks | 
| Ankle function | Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse | Change from baseline FADI at 12 weeks |