Taipei medical university
Taipei, 116, Taiwan
NCT Number: NCT03868995
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Taipei, 116, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dextrose water injection to subcutaneous layer at tender point
Dextrose water injection to injured tendon
Time frame: Change from baseline VAS at 1 week
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Time frame: Change from baseline VAS at 4 week
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Time frame: Change from baseline VAS at 12 week
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Time frame: Change from baseline of difference of ankle degree at 1 week
The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
Time frame: Change from baseline of difference of ankle degree at 4 weeks
The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
Time frame: Change from baseline of difference of ankle degree at 12 weeks
The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
Time frame: Change from baseline FADI at 1 week
Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
Time frame: Change from baseline FADI at 4 weeks
Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
Time frame: Change from baseline FADI at 12 weeks
Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
Taipei Medical University WanFang Hospital
Other
The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain: A Randomized Controlled Trial
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