NCT03868995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 19, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

January 21, 2019

Last Update Submit

September 15, 2024

Conditions

Ankle Sprains

Outcome Measures

Primary Outcomes (3)

  • Ankle pain

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

    Change from baseline VAS at 1 week

  • Ankle pain

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

    Change from baseline VAS at 4 week

  • Ankle pain

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

    Change from baseline VAS at 12 week

Secondary Outcomes (6)

  • Ankle proprioception

    Change from baseline of difference of ankle degree at 1 week

  • Ankle proprioception

    Change from baseline of difference of ankle degree at 4 weeks

  • Ankle proprioception

    Change from baseline of difference of ankle degree at 12 weeks

  • Ankle function

    Change from baseline FADI at 1 week

  • Ankle function

    Change from baseline FADI at 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Sham injection

SHAM COMPARATOR

Dextrose water injection to subcutaneous layer at tender point

Procedure: Sham injection

Tendon injection

EXPERIMENTAL

Dextrose water injection to injured tendon

Procedure: Tendon injection

Interventions

Sham injectionPROCEDURE

Dextrose water injection to subcutaneous layer at tender point

Sham injection
Tendon injectionPROCEDURE

Dextrose water injection to injured tendon

Tendon injection

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age
  • Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation
  • Ultrasound diagnosed anterior talofibular ligament sprain

You may not qualify if:

  • Acute ankle sprain less than 3 months
  • Lower limb fracture history
  • Cognitive impairment
  • Other neurological or muscular disorders
  • Sever pain could not tolerate examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei medical university

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Yu-Hsuan Cheng, MS

    Taipei Medical University, Taiwan, R.O.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

March 11, 2019

Study Start

November 1, 2019

Primary Completion

July 1, 2021

Study Completion

December 31, 2022

Last Updated

September 19, 2024

Record last verified: 2023-12

Locations

TW(1)