Clinical trial NCT03418051: Mechanisms of Manual Therapies in CAI Patients
Official title: Neuromuscular Mechanisms of Manual Therapies in Chronic Ankle Instability Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Inversion Sprain
Chronic Instability of Joint
Keywords: Ankle Instability
Manual Therapy
Massage
Ankle Joint Mobilization
Biomechanics
Neuromuscular
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion criteria:

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.

Exclusion criteria for Chronic Ankle Instability will include:

* 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.

Primary outcomes:
measure: ML COP Velocity From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: ML COP Velocity From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: AP COP Velocity From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: AP COP Velocity From Baseline to Follow-up
timeFrame: Baseline and 4-week Follow-Up
measure: ML TTB From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: ML TTB From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: AP TTB From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: AP TTB From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: 95% Confidence Ellipse From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: 95% Confidence Ellipse From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
Secondary outcomes:
measure: Plantar Flexion Joint Position Sense From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Plantar Flexion Joint Position Sense From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow Up
measure: Soleus H:M Ratio From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Soleus H:M Ratio From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Fibularis Longus H:M Ratio From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Fibularis Longus H:M Ratio From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Fibularis Longus Active Motor Threshold From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Fibularis Longus Active Motor Threshold From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Cortical Silent Period From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Cortical Silent Period From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Corticomotor Map Area From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Corticomotor Map Area From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Corticomotor Map Volume From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Corticomotor Map Volume From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Alpha Power Spectral Density From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Alpha Power Spectral Density From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Beta Power Spectral Density From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Beta Power Spectral Density From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
measure: Gamma Power Spectral Density From Baseline to Post Intervention
timeFrame: Baseline and 24-72 hours post intervention
measure: Gamma Power Spectral Density From Baseline to Follow-Up
timeFrame: Baseline and 4-week Follow-Up
Other outcomes:
measure: Walking Ankle Dorsiflexion at Baseline
timeFrame: Baseline
measure: Walking Ankle Dorsiflexion Immediately Post Intervention
timeFrame: 24-72 hours post intervention
measure: Walking Ankle Dorsiflexion at 4-weeks Post Intervention
timeFrame: 4-weeks post intervention
measure: Walking Loading Rate at Baseline
timeFrame: Baseline
measure: Walking Loading Rate Immediately Post Intervention
timeFrame: 24-72 hours post intervention
measure: Walking Loading Rate at 4-weeks Post Intervention
timeFrame: 4-weeks post intervention
measure: Landing Ankle Dorsiflexion at Baseline
timeFrame: Baseline
measure: Landing Ankle Dorsiflexion Immediately Post Intervention
timeFrame: 24-72 hours post intervention
measure: Landing Ankle Dorsiflexion at 4-weeks Post Intervention
timeFrame: 4-weeks post intervention
measure: Landing Loading Rate at Baseline
timeFrame: Baseline
measure: Landing Loading Rate Immediately Post Intervention
timeFrame: 24-72 hours post intervention
measure: Landing Loading Rate at 4-weeks Post Intervention
timeFrame: 4-weeks post intervention
Locations:
city: Chapel Hill
country: United States
facility: Fetzer Hall
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Erik Wikstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References: