Mechanisms of Manual Therapies in CAI Patients

NCT03418051 | Completed Results DMC

• 2 other identifiers: 17-26551R21AT009704-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT: Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a multifaceted condition linked with life-long residual symptoms and post-traumatic ankle osteoarthritis. Our long term goal is to develop intervention strategies to decrease disability associated with acute and chronic ankle injury and prevent posttraumatic ankle osteoarthritis. Conventional rehabilitation strategies, are only moderately successful because they ignore the full spectrum of residual symptoms associated with CAI. Manual therapies such as ankle joint mobilizations and plantar massage target sensory pathways not addressed by conventional treatments and have been shown to improve patient-reported outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these early results are promising, the underlying neuromuscular mechanisms of these manual therapies remain unknown. Therefore the objective of this R21 proposal is to determine the neuromuscular mechanisms underlying the improvements observed following independent ankle joint mobilization and plantar massage interventions in CAI patients. To comprehensively evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical excitability, and cortical mapping, sensory organization) will be assessed. Participants will then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over 2-weeks. Post-intervention assessments will be completed within 48-hours of the final treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral, spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also be assessed. The results of this investigation will elucidate multifaceted mechanisms of novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those with CAI.

Conditions

Ankle Inversion Sprain; Chronic Instability of Joint

Keywords

Ankle Instability; Manual Therapy; Massage; Ankle Joint Mobilization; Biomechanics; Neuromuscular

Outcome Measures

Primary Outcomes (10)

• ML COP Velocity From Baseline to Post Intervention

  % Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

  Baseline and 24-72 hours post intervention

• ML COP Velocity From Baseline to Follow-Up

  % Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the Follow-Up assessment.

  Baseline and 4-week Follow-Up

• AP COP Velocity From Baseline to Post Intervention

  % Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

  Baseline and 24-72 hours post intervention

• AP COP Velocity From Baseline to Follow-up

  % Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the follow-up assessment.

  Baseline and 4-week Follow-Up

• ML TTB From Baseline to Post Intervention

  % Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.

  Baseline and 24-72 hours post intervention

• ML TTB From Baseline to Follow-Up

  % Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.

  Baseline and 4-week Follow-Up

• AP TTB From Baseline to Post Intervention

  % Modulation of AP Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.

  Baseline and 24-72 hours post intervention

• AP TTB From Baseline to Follow-Up

  % Modulation of AP Time-to-Boundary. First, time-to-Boundary is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.

  Baseline and 4-week Follow-Up

• 95% Confidence Ellipse From Baseline to Post Intervention

  % Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

  Baseline and 24-72 hours post intervention

• 95% Confidence Ellipse From Baseline to Follow-Up

  % Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

  Baseline and 4-week Follow-Up

Secondary Outcomes (24)

• Plantar Flexion Joint Position Sense From Baseline to Post Intervention

  Baseline and 24-72 hours post intervention

• Plantar Flexion Joint Position Sense From Baseline to Follow-Up

  Baseline and 4-week Follow-Up

• 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention

  Baseline and 24-72 hours post intervention

• 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up

  Baseline and 4-week Follow-Up

• 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention

  Baseline and 24-72 hours post intervention

Other Outcomes (12)

• Walking Ankle Dorsiflexion at Baseline

  Baseline

• Walking Ankle Dorsiflexion Immediately Post Intervention

  24-72 hours post intervention

• Walking Ankle Dorsiflexion at 4-weeks Post Intervention

  4-weeks post intervention

Study Arms (3)

Control

NO INTERVENTION

Control group that will receive no intervention throughout the duration of the study (2-weeks).

Joint Mobilization

EXPERIMENTAL

Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.

Other: Joint Mobilization

Massage

EXPERIMENTAL

Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.

Other: Massage

Interventions

Joint Mobilization OTHER

Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade II anterior to posterior ankle joint mobilizations with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.

Also known as: Ankle Joint Mobilization

Joint Mobilization

Massage OTHER

Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.

Also known as: Plantar Massage

Massage

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals with Chronic Ankle Instability which will be defined as those individuals who:
• have sustained at least two lateral ankle sprains;
• have experienced at least one episode of giving way within the past 6-months;
• answer 4 or more questions of "yes" on the Ankle Instability Instrument;
• have self-assessed disability scores of ≤90% on the Foot and Ankle Ability Measure;
• have self-assessed disability scores ≤80% on the Foot and Ankle Ability Measure-Sport.

You may not qualify if:

• known vestibular and vision problems,
• acute lower extremities and head injuries (\<6 weeks),
• chronic musculoskeletal conditions known to affect balance (e.g., Anterior Cruciate Ligament deficiency) and
• a history of ankle surgeries to fix internal derangement.
• Participants will also be excluded if they have any of the following which are contraindications to Transcranial Magnetic Stimulation testing:
• metal anywhere in the head (except in the mouth),
• pacemakers,
• implantable medical pumps,
• ventriculo-peritoneal shunts,
• intracardiac lines,
• history of seizures,
• history of stroke
• history of serious head trauma.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Fetzer Hall

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Erik Wikstrom
• Organization: University of North Carolina at Chapel Hill

wikstrom@unc.edu

9199622260

Study Officials

• Erik Wikstrom, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 1, 2018
• Study Start: September 1, 2018
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available following completion of the study for two years.
• Access Criteria: Data will be made available to other investigators that contact the PI and provide written commitment (i.e. data use agreement) to: 1) only use the data for purposes currently unplanned by the principal investigators or co-investigators; 2) only use the data for research purposes and not to contact patients or potential future research subjects; 3) securing the data using appropriate computer technology; as well as 4) destroying or returning the data following completion of data analysis.

Locations

US (1)