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Completed

NCT Number: NCT03868995

The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

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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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei medical university

Taipei, 116, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham injection

Procedure

Dextrose water injection to subcutaneous layer at tender point

Tendon injection

Procedure

Dextrose water injection to injured tendon

Primary outcomes

  1. Ankle pain

    Time frame: Change from baseline VAS at 1 week

    visual analogue scale(VAS), range 0-10, the higher scale the worsen pain

  2. Ankle pain

    Time frame: Change from baseline VAS at 4 week

    visual analogue scale(VAS), range 0-10, the higher scale the worsen pain

  3. Ankle pain

    Time frame: Change from baseline VAS at 12 week

    visual analogue scale(VAS), range 0-10, the higher scale the worsen pain

Secondary outcomes

  1. Ankle proprioception

    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

  2. Ankle proprioception

    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

  3. Ankle proprioception

    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

  4. Ankle function

    Time frame: Change from baseline FADI at 1 week

    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse

  5. Ankle function

    Time frame: Change from baseline FADI at 4 weeks

    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse

  6. Ankle function

    Time frame: Change from baseline FADI at 12 weeks

    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 11, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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