Ankle Sprains
Conditions
Brief summary
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
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.
Interventions
PROCEDURESham injection
Dextrose water injection to subcutaneous layer at tender point
PROCEDURETendon injection
Dextrose water injection to injured tendon
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 20-70 age 2. Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation 3. Ultrasound diagnosed anterior talofibular ligament sprain
Exclusion criteria
1. Acute ankle sprain less than 3 months 2. Lower limb fracture history 3. Cognitive impairment 4. Other neurological or muscular disorders 5. Sever pain could not tolerate examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle pain | Change from baseline VAS at 1 week | visual analogue scale(VAS), range 0-10, the higher scale the worsen pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle proprioception | 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 |
| Ankle function | Change from baseline FADI at 1 week | Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse |
Countries
Taiwan
Outcome results
None listed