The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

Taipei Medical University

Status: Completed

Conditions: Ankle Sprains

Treatments: Procedure: Sham injection; Procedure: Tendon injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03868995

N201810066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups

Sham injection

Sham Comparator group

Description:

Dextrose water injection to subcutaneous layer at tender point

Treatment:

Procedure: Sham injection

Tendon injection

Experimental group

Description:

Dextrose water injection to injured tendon

Treatment:

Procedure: Tendon injection