NMES and Chronic Ankle Instability

NCT ID: NCT04322409

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-11-01

Brief Summary

Chronic ankle instability is associated with changes in the nervous system that amount to increased difficulty in activating the stabilizing muscles of the ankle. Neuromuscular Electrical Stimulation involves using electricity to activate those muscles in bursts, and is commonly used to improve muscle function in those with ACL injury. This study will provide 5 treatments over 2 weeks in patients with Chronic Ankle Instability and determine if Electrical Stimulation can change neural excitability, balance, neuromuscular control, and perceived function in these individuals.

Detailed Description

Individuals with joint injuries, including ankle sprain and anterior cruciate ligament (ACL) injury have been observed to exhibit changes in central nervous system function that potentially predispose them for further injury (Needle et al. 2017). In ankle sprains, repeated sensations of rolling and giving-way known as chronic ankle instability (CAI) emerges in nearly 50 percent of those with a history of ankle sprain (Holland et al. 2019), with symptoms tied to changes in central nervous system function. As the understanding of these pathologies have expanded, researchers have begun to attempt to identify neuromodulatory interventions capable of addressing injury-induced maladaptive neuroplasticity, thus improving function (Bruce et al. 2020, In Press).

Among those with ACL injury, one of the most common interventions implemented to overcome muscle activation deficits includes neuromuscular electrical stimulation (NMES) (Lepley et al. 2015). This intervention is often used in the initial stages of post-surgical recovery to improve quadriceps function; however, it's use in other populations of joint injury (i.e. ankle sprain) is far more limited. Some previous research has looked at the effects of NMES on acute ankle sprains, as this is the timeframe in which muscle activation deficits would be most evident (Wainwright et al. 2019), but there is very limited evidence in those with CAI. It was potentially thought that activation deficits are less evident and strengthening may overcome these deficits in those with chronic injury; however, new insights have identified additional mechanisms by which NMES may be effective (Lepley et al. 2015). Aside from generating activation of a generally inactive muscle, NMES when performed at high intensities has been described to improve neuromuscular function through disinhibitory mechanisms. That is that increased somatosensation from the electrical stimulation raises the central nervous sytem's awareness of that muscle's activation, yielding decreased inhibition and ultimately increased neural excitability.

Our previous research using cortically-directed interventions demonstrated that improving neural excitability yielded better function in patients with chronic ankle instability (Bruce et al. 2020). This study will follow a similar framework; however, determining if these changes can be induced via a peripheral intervention. These findings have the ability to reframe the current treatment for CAI.

We are pursuing the following 2 specific aims:

1. To determine if NMES changes neural excitability (MEP size, H:M ratio, silent period) compared to a placebo treatment in participants with chronic ankle instability.

H1: NMES will increase MEP size, H:M ratio, and decrease cortical silent period in individuals with CAI compared to the placebo treatment.

2. To determine if changes in neural excitability related to NMES or placebo treatment result in improved function (balance, muscle activation, outcomes) in participants with chronic ankle instability.

H2: Increased neural excitability will yield improved balance (postural stability indices), muscle activation, and patient-reported function.

Conditions

Chronic Ankle Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NMES

The experimental treatment of Neuromuscular Electrical Stimulation over the Peroneus Longus.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: DEVICE

5 sessions that consist of NMES over the peroneus longus muscle. This consists of a biphasic current with a phase duration of 240us delivered in a frequency of 75 pules per second, with a ramp-up time of 2-seconds, followed by a 50-s rest period (no stimulation). Each cycle will consist of 10 seconds of "on" time, and 50 seconds off, with 10 cycles being performed each session.

TENS

The placebo treatment of Transcutaneous Electrical Nerve Stimulation over the same region as the peroneus longus

Group Type: PLACEBO_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

5 sessions that consist of 11-minutes of TENS over the skin of the peroneus longus. This consists of a biphasic current will be continuously applied at 100 pulses per second, with a phase duration of 100us for 10 minutes. The intensity will be turned up until the point the subjects feel the current (sensory threshold)

Interventions

Neuromuscular Electrical Stimulation

5 sessions that consist of NMES over the peroneus longus muscle. This consists of a biphasic current with a phase duration of 240us delivered in a frequency of 75 pules per second, with a ramp-up time of 2-seconds, followed by a 50-s rest period (no stimulation). Each cycle will consist of 10 seconds of "on" time, and 50 seconds off, with 10 cycles being performed each session.

Intervention Type: DEVICE

Transcutaneous Electrical Nerve Stimulation

5 sessions that consist of 11-minutes of TENS over the skin of the peroneus longus. This consists of a biphasic current will be continuously applied at 100 pulses per second, with a phase duration of 100us for 10 minutes. The intensity will be turned up until the point the subjects feel the current (sensory threshold)

Intervention Type: DEVICE

Other Intervention Names

NMES; TENS

Eligibility Criteria

Exclusion Criteria

• History of fracture or surgery to the legs
• Injury to the lower legs within 3 months prior to reporting for testing that resulted in modified physical activity.
• Currently involved in an ankle rehabilitation program.
• Failing to meet standards for the safe practice of transcranial magnetic stimulation and transcranial direct current stimulation (See questionnaire). Briefly, this includes personal or family history of seizure or epilepsy; current medication use that raises risk of seizure; implanted metal, medication devices, etc.; history of brain or heart surgery; and sensitivity of the scalp or skin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Appalachian State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leon Levine Hall for Health Sciences

Boone, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alan R Needle, Ph.D.

Role: CONTACT

needlear@appstate.edu

8282624039

Facility Contacts

Alan R Needle

Role: primary

needlear@appstate.edu

828-262-4039

References

Needle AR, Tinsley JE, Cash JJ, Koeval BK, Barton JA, Howard JS. The effects of neuromuscular electrical stimulation to the ankle pronators on neural excitability & functional status in patients with chronic ankle instability. Phys Ther Sport. 2023 Mar;60:1-8. doi: 10.1016/j.ptsp.2022.12.001. Epub 2022 Dec 9.

Reference Type: DERIVED

PMID: 36634453 (View on PubMed)

Other Identifiers

20-042

Identifier Type: -

Identifier Source: org_study_id