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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056795
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Canadian Memorial Chiropractic College

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ankle Sprain Device: Asia-Med Special No 16 (0.30x30mm) needles Device: Streitberger placebo needles (Asia-Med, 0.03 x 30 mm) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: A Single Application of Electroacupuncture Improves Balance Greater Than Placebo Control in Subjects With Chronic Functional Ankle Instability
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Electroacupuncture
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.
 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.
Other Name: Electroacupuncture
Sham Comparator: Control
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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Tests of single-leg standing [ Time Frame: 10 seconds ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-50 years old
  • History of inversion ankle sprains
  • Chronic symptoms of instability

Exclusion Criteria:

  • Please see inclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056795


Locations
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Canada, Ontario
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada, M2H 3J1
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Investigators
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Principal Investigator: Tracy Rowan, DC Canadian Memorial Chiropractic College
More Information
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Responsible Party: Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT02056795    
Other Study ID Numbers: 122017
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries