The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03868995
Study type	Interventional
Source	Taipei Medical University WanFang Hospital
Contact	Yu-Hsuan Cheng, MS
Phone	886-229307930
Email	heathcyh@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	April 1, 2019
Completion date	December 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04367532` - Foam Rolling and Tissue Flossing of the Cuff Muscles	N/A
Not yet recruiting	`NCT05484778` - Analysis of Balance and Functional Hop Tests Used for Return to Sports in Athletes With Lower Extremity Injuries by Dual Task Study	N/A
Completed	`NCT06390072` - Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability	N/A
Completed	`NCT01198834` - MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains	Phase 3
Recruiting	`NCT05916300` - Diagnostic Ultrasonography in Physiotherapy
Recruiting	`NCT04493645` - Ankle Instability Using Foot Intensive Rehabilitation	N/A
Completed	`NCT04114552` - Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain
Completed	`NCT04773990` - Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS	N/A
Recruiting	`NCT03472404` - inStability Treated With Ligament RecOnstruction Augmented With iNternal bracinG	N/A
Completed	`NCT04999254` - Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain	N/A
Withdrawn	`NCT03309098` - Agreement Between Clinician and Instrumented Laxity Assessment
Recruiting	`NCT03663361` - Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation	N/A
Completed	`NCT05602233` - The Effect of Balance Training Following STARS on Postural Control	N/A
Recruiting	`NCT05698446` - Comparison of MBR + Suture Tape and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study
Recruiting	`NCT05412186` - Urdu Version Of Cumberland Ankle Instability Tool: Reliability And Validity Study
Active, not recruiting	`NCT03527121` - Management of Acute Lateral Ankle Sprains	N/A
Not yet recruiting	`NCT06356818` - Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability	N/A
Not yet recruiting	`NCT04516980` - Validation of the Identification of Functional Ankle Instability (IdFAI) in Italian
Completed	`NCT03634280` - Efficacy of Kinesio Taping and Splinting in Ankle Sprain	N/A
Completed	`NCT05331365` - Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms