Ankle SprainsNCT03868995
The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain
A study testing Tendon injection in people with Ankle Sprains, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Tendon injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-70 age
- Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation
- Ultrasound diagnosed anterior talofibular ligament sprain
Who cannot join
- Acute ankle sprain less than 3 months
- Lower limb fracture history
- Cognitive impairment
- Other neurological or muscular disorders
- Sever pain could not tolerate examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Sprains
- Being tested
- Sham injection, Tendon injection
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham injectionProcedure or surgery
Dextrose water injection to subcutaneous layer at tender point
Tendon injectionProcedure or surgery
Dextrose water injection to injured tendon
| Study group | Role | What they receive |
|---|---|---|
| Sham injection | Sham comparator | Dextrose water injection to subcutaneous layer at tender point Receives: Procedure: Sham injection |
| Tendon injection | Experimental | Dextrose water injection to injured tendon Receives: Procedure: Tendon injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle pain
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Measured: Change from baseline VAS at 1 week
Ankle pain
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Measured: Change from baseline VAS at 4 week
Ankle pain
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Measured: Change from baseline VAS at 12 week
Secondary outcomes (6)
Ankle proprioception
The accuracy of ankle range of motion at 0 degree, half of dorsiflexion and half of plantar flexion
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline FADI at 1 week
Ankle function
Foot \& Ankle Disability Index (FADI), range 0-136, the higher the worse
Measured: Change from baseline FADI at 4 weeks
Ankle function
Foot \& Ankle Disability Index (FADI), range 0-136, the higher the worse
Measured: Change from baseline FADI at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Nov 2019
- Primary completion1 Jul 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsuan Cheng, MS, Study director, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868995
- Sponsor's protocol ID
- N201810066
- Status last verified
- Dec 2023
- First submitted
- 21 Jan 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03868995
- Acronym / sponsor ID
- N201810066
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham injection | Sham comparator | Procedure: Sham injectionDextrose water injection to subcutaneous layer at tender point |
| Tendon injection | Experimental | Procedure: Tendon injectionDextrose water injection to injured tendon |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20-70 age
- Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation
- Ultrasound diagnosed anterior talofibular ligament sprain
Key exclusion criteria (5 listed)
- Acute ankle sprain less than 3 months
- Lower limb fracture history
- Cognitive impairment
- Other neurological or muscular disorders
- Sever pain could not tolerate examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham injectionDextrose water injection to subcutaneous layer at tender point | Procedure or surgery | Sham injection |
| Tendon injectionDextrose water injection to injured tendon | Procedure or surgery | Tendon injection |
Primary outcome
Ankle pain
Time frame: Change from baseline VAS at 1 week
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Ankle pain
Time frame: Change from baseline VAS at 4 week
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
Ankle pain
Time frame: Change from baseline VAS at 12 week
visual analogue scale(VAS), range 0-10, the higher scale the worsen pain
6 secondary outcomes
Ankle proprioception
Time frame: Change from baseline of difference of ankle degree at 1 week
Ankle proprioception
Time frame: Change from baseline of difference of ankle degree at 4 weeks
Ankle proprioception
Time frame: Change from baseline of difference of ankle degree at 12 weeks
Ankle function
Time frame: Change from baseline FADI at 1 week
Ankle function
Time frame: Change from baseline FADI at 4 weeks
Ankle function
Time frame: Change from baseline FADI at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Sprains
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Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
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Enovis High Ankle Sprain Brace Testing
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
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Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsuan Cheng, MS study director
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendon injection in people with Ankle Sprains, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle pain (time frame: Change from baseline VAS at 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.