The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Sprains
• Intervention / Treatment: Procedure: Sham injection; Procedure: Tendon 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham injection; Dextrose water injection to subcutaneous layer at tender point	Procedure: Sham injection; Dextrose water injection to subcutaneous layer at tender point
Experimental: Tendon injection; Dextrose water injection to injured tendon	Procedure: Tendon injection; Dextrose water injection to injured tendon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Study Director: Yu-Hsuan Cheng, MS, Taipei Medical University, Taiwan, R.O.C.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: N201810066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No