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
About this trial
This is an interventional treatment trial for Ankle Sprains
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
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
NCT ID
NCT03868995
First Posted
January 21, 2019
Last Updated
March 6, 2019
Sponsor
Taipei Medical University WanFang Hospital
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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