Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 346 for:    sprains and strains

The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03868995
Recruitment Status : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

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.

Condition or disease Intervention/treatment Phase
Ankle Sprains Procedure: Sham injection Procedure: Tendon injection Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain: A Randomized Controlled Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868995


Contacts
Layout table for location contacts
Contact: Yu-Hsuan Cheng, MS 886-229307930 heathcyh@gmail.com

Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Layout table for investigator information
Study Director: Yu-Hsuan Cheng, MS Taipei Medical University, Taiwan, R.O.C.

Layout table for additonal information
Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03868995     History of Changes
Other Study ID Numbers: N201810066
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries