Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT02056795
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2014-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Effects of Electroacupuncture on Balance in Subjects With Chronic Functional Ankle Instability
Sponsor:
Canadian Memorial Chiropractic College
Organization:
Study Overview
Official Title:
A Single Application of Electroacupuncture Improves Balance Greater Than Placebo Control in Subjects With Chronic Functional Ankle Instability
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction: Ankle sprains, the most common sports-related musculoskeletal injury, account for approximately 25% of sports injuries. An estimated 40% of these individuals will progress to develop chronic functional ankle instability (CFAI), which can significantly affect athletic performance and activities of daily life. Stresses from the injury can damage the ligaments, muscles, nerves and mechanoreceptors. It is widely accepted that ankle proprioception is critical for balance and that individuals with CFAI demonstrate decreased proprioception and altered muscular function, which impairs postural stability. The goal of this study is to determine if a single application of electroacupuncture can have an immediate positive outcome related to balance in individuals with CFAI.
Methods: This single blinded randomized trial will include 12 subjects receiving a single application of electroacupuncture and 12 subjects in the placebo group receiving sham electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed pre- and post-treatment using force plate data during a single-leg stance and via the Star Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and non-traditional points on the medial aspect of the leg will be used for the sham electroacupuncture group. Both will be connected to the electrical stimulation unit for 10 minutes. Results from this study may inform future research investigating the ability of EA at decreasing the risk of ankle sprains, improving perceived stability, and reducing the risk of subsequent degenerative changes.
Methods: This single blinded randomized trial will include 12 subjects receiving a single application of electroacupuncture and 12 subjects in the placebo group receiving sham electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed pre- and post-treatment using force plate data during a single-leg stance and via the Star Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and non-traditional points on the medial aspect of the leg will be used for the sham electroacupuncture group. Both will be connected to the electrical stimulation unit for 10 minutes. Results from this study may inform future research investigating the ability of EA at decreasing the risk of ankle sprains, improving perceived stability, and reducing the risk of subsequent degenerative changes.
Detailed Description:
A single application of electroacupuncture improves balance greater than placebo control in subjects with chronic functional ankle instability
Specific Aim #1:
Evaluate the effect of a single application of electroacupuncture on center of pressure mean total velocity in individuals with chronic functional ankle instability during single-leg stance compared to placebo control.
H0: EA will not improve postural sway during single-leg stance compared to placebo control.
Specific Aim #2:
Describe the effects of a single application of EA compared to placebo on mean total displacement, as well as the mediolateral and anterioposterior components during single-leg stance for possible trends to inform hypothesis generation.
Specific Aim #3:
Correlate the results from the Star Excursion Balance Test with results of the single-leg stance measures to inform hypothesis generation.
Specific Aim #1:
Evaluate the effect of a single application of electroacupuncture on center of pressure mean total velocity in individuals with chronic functional ankle instability during single-leg stance compared to placebo control.
H0: EA will not improve postural sway during single-leg stance compared to placebo control.
Specific Aim #2:
Describe the effects of a single application of EA compared to placebo on mean total displacement, as well as the mediolateral and anterioposterior components during single-leg stance for possible trends to inform hypothesis generation.
Specific Aim #3:
Correlate the results from the Star Excursion Balance Test with results of the single-leg stance measures to inform hypothesis generation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: