Ankle SprainNCT02056795
Study of Effects of Electroacupuncture on Balance in Subjects With Chronic Functional Ankle Instability
A study testing Asia-Med Special No 16 (0.30x30mm) needles in people with Ankle Sprain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Asia-Med Special No 16 (0.30x30mm) needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Apr 2013
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years old
- History of inversion ankle sprains
- Chronic symptoms of instability
Who cannot join
- Please see inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Application of Electroacupuncture Improves Balance Greater Than Placebo Control in Subjects With Chronic Functional Ankle Instability
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.
Read the 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.
- Conditions
- Ankle Sprain
- Being tested
- Asia-Med Special No 16 (0.30x30mm) needles, Streitberger placebo needles (Asia-Med, 0.03 x 30 mm)
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asia-Med Special No 16 (0.30x30mm) needlesDevice
Also called 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.
Streitberger placebo needles (Asia-Med, 0.03 x 30 mm)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | 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. Receives: Device: Asia-Med Special No 16 (0.30x30mm) needles |
| Control | Sham comparator | 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. Receives: Device: Streitberger placebo needles (Asia-Med, 0.03 x 30 mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy Rowan, DC, Principal investigator, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056795
- Sponsor's protocol ID
- 122017
- Status last verified
- Mar 2014
- First submitted
- 24 Jan 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Application of Electroacupuncture Improves Balance Greater Than Placebo Control in Subjects With Chronic Functional Ankle Instability
- ClinicalTrials.gov ID
- NCT02056795
- Acronym / sponsor ID
- 122017
- Conditions
- Ankle Sprain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Feb 2014 (estimated)
- 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.
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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: Asia-Med Special No 16 (0.30x30mm) needlesSubjects 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. |
| Control | Sham comparator | 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50 years old
- History of inversion ankle sprains
- Chronic symptoms of instability
Key exclusion criteria (1 listed)
- Please see inclusion criteria
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 |
|---|---|---|
| Asia-Med Special No 16 (0.30x30mm) needlesAlso: ElectroacupunctureSubjects 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 | Electroacupuncture |
| 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. | Device | Control |
Primary outcome
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
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 Mar 2014.
Related trials for Ankle Sprain
Not yet recruiting
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
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
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.
Tracy Rowan, DC principal investigator
Canadian Memorial Chiropractic College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asia-Med Special No 16 (0.30x30mm) needles in people with Ankle Sprain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
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 1 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 Mar 2014. 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 Canada. 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?
Tests of single-leg standing (time frame: 10 seconds). 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 Mar 2014.