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The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

Primary Purpose

Ankle Sprains

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sham injection
Tendon injection
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Sham injection

    Tendon injection

    Arm Description

    Dextrose water injection to subcutaneous layer at tender point

    Dextrose water injection to injured tendon

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Ankle proprioception
    The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
    Ankle proprioception
    The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
    Ankle proprioception
    The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
    Ankle function
    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
    Ankle function
    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
    Ankle function
    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse

    Full Information

    First Posted
    January 21, 2019
    Last Updated
    March 6, 2019
    Sponsor
    Taipei Medical University WanFang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03868995
    Brief Title
    The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain
    Official Title
    The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University WanFang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Sprains

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham injection
    Arm Type
    Sham Comparator
    Arm Description
    Dextrose water injection to subcutaneous layer at tender point
    Arm Title
    Tendon injection
    Arm Type
    Experimental
    Arm Description
    Dextrose water injection to injured tendon
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham injection
    Intervention Description
    Dextrose water injection to subcutaneous layer at tender point
    Intervention Type
    Procedure
    Intervention Name(s)
    Tendon injection
    Intervention Description
    Dextrose water injection to injured tendon
    Primary Outcome Measure Information:
    Title
    Ankle pain
    Description
    visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
    Time Frame
    Change from baseline VAS at 1 week
    Title
    Ankle pain
    Description
    visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
    Time Frame
    Change from baseline VAS at 4 week
    Title
    Ankle pain
    Description
    visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
    Time Frame
    Change from baseline VAS at 12 week
    Secondary Outcome Measure Information:
    Title
    Ankle proprioception
    Description
    The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
    Time Frame
    Change from baseline of difference of ankle degree at 1 week
    Title
    Ankle proprioception
    Description
    The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
    Time Frame
    Change from baseline of difference of ankle degree at 4 weeks
    Title
    Ankle proprioception
    Description
    The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
    Time Frame
    Change from baseline of difference of ankle degree at 12 weeks
    Title
    Ankle function
    Description
    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
    Time Frame
    Change from baseline FADI at 1 week
    Title
    Ankle function
    Description
    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
    Time Frame
    Change from baseline FADI at 4 weeks
    Title
    Ankle function
    Description
    Foot & Ankle Disability Index (FADI), range 0-136, the higher the worse
    Time Frame
    Change from baseline FADI at 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Hsuan Cheng, MS
    Phone
    886-229307930
    Email
    heathcyh@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Hsuan Cheng, MS
    Organizational Affiliation
    Taipei Medical University, Taiwan, R.O.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

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