Study of Effects of Electroacupuncture on Balance in Subjects With Chronic Functional Ankle Instability

Ankle Sprain Clinical Trial

Official title:

A Single Application of Electroacupuncture Improves Balance Greater Than Placebo Control in Subjects With Chronic Functional Ankle Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056795
• Other study ID #: 122017
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: March 18, 2014
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: Canadian Memorial Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18-50 years old

• History of inversion ankle sprains

• Chronic symptoms of instability

Exclusion Criteria:

• Please see inclusion criteria

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Ankle Sprain

Intervention

Device:
• Asia-Med Special No 16 (0.30x30mm) needles
Subjects will do balance assessment in lab. In treatment room, practitioner will clean insertion area with alcohol swab, allow adequate time to dry, and insert 2 Asia-Med Special No 16 (0.30x30mm) needles: one at proximal insertion of fibularis longus anterior to fibular neck, in proximity to common fibular nerve (GB-34); one over sinus tarsi and lateral ligaments of ankle mortise (GB-40). Needles will be inserted approximately 1-2cm, connected for 10 min at 2Hz to electrical stimulation (ITO ES-130, 500 ohm test load, 1 to 500Hz). Needles will disposed of in sharps container. Area will be wiped with long handled cotton swab, pressure will be applied for 2 seconds. Subjects will be asked to slowly get up from table and return to lab for second balance assessment.
• Streitberger placebo needles (Asia-Med, 0.03 x 30 mm)
As with experimental group, controls will do balance assessment pre- and post-intervention. Streitberger placebo needles (Asia-Med, 0.03 x 30 mm), blunted with a telescoping mechanism, will be used. Subjects will feel slight prick, and shaft will telescope into handle, creating illusion of skin penetration. Needles will be held in place by plastic ring covered by a bandage. They are validated for blinding. They will be placed over non-traditional acupuncture points on medial aspect of leg, in direct opposition to treatment group needles. Needle placement is not intended to produce therapeutic outcome. The needles will be connected to a wire, which will be turned on for 10 minutes but no stimulation will be felt.

Locations

Country	Name	City	State
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tests of single-leg standing	Tests of single-leg standing balance have been demonstrated to have moderate to excellent group reliability, and therefore are being utilized to compare the balance performance of subjects with chronic functional ankle instability	10 seconds	No