N/A
N=60
Mechanisms of Manual Therapies in CAI Patients
Ankle Inversion Sprain · Chronic Instability of Joint
Bottom Line
View on ClinicalTrials.gov: NCT03418051 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: ML COP Velocity From Baseline to Post Intervention — 119.91; 118.91; 121.07; 116.99 % modulation — p=0.824
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Joint Mobilization (Other); Massage (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ML COP Velocity From Baseline to Post Intervention |
119.91; 118.91; 121.07; 116.99; 128.23; 121.20 | 0.824 |
| PRIMARY ML COP Velocity From Baseline to Follow-Up |
119.71; 116.13; 119.14; 118.86; 110.80; 111.06 | 0.722 |
| PRIMARY AP COP Velocity From Baseline to Post Intervention |
117.40; 115.84; 126.50; 120.91; 122.51; 100.91 | 0.046 sig |
| PRIMARY AP COP Velocity From Baseline to Follow-up |
119.48; 116.69; 123.93; 117.67; 105.10; 97.96 | 0.138 |
| PRIMARY ML TTB From Baseline to Post Intervention |
-50.76; -54.97; -55.41; -55.99; -56.61; -52.28 | 0.069 |
| PRIMARY ML TTB From Baseline to Follow-Up |
-48.98; -54.18; -51.12; -51.12; -52.18; -53.12 | 0.604 |
| PRIMARY AP TTB From Baseline to Post Intervention |
-52.54; -54.59; -57.53; -52.97; -54.39; -48.81 | 0.005 sig |
| PRIMARY AP TTB From Baseline to Follow-Up |
-52.95; -55.09; -53.98; -51.94; -47.38; -48.81 | 0.142 |
| PRIMARY 95% Confidence Ellipse From Baseline to Post Intervention |
270.91; 270.91; 290.70; 267.85; 283.26; 275.92 | 0.849 |
| PRIMARY 95% Confidence Ellipse From Baseline to Follow-Up |
286.29; 272.07; 282.06; 317.46; 254.06; 267.92 | 0.535 |
| SECONDARY Plantar Flexion Joint Position Sense From Baseline to Post Intervention |
3.00; 3.25; 3.73; 2.22; 1.97; 2.42 | 0.405 |
| SECONDARY Plantar Flexion Joint Position Sense From Baseline to Follow-Up |
3.04; 3.04; 3.72; 2.35; 1.51; 2.62 | 0.609 |
| SECONDARY 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention |
2.83; 3.22; 3.61; 3.41; 3.22; 2.83 | 0.613 |
| SECONDARY 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up |
2.95; 3.22; 3.41; 3.22; 3.22; 2.83 | 0.925 |
| SECONDARY 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention |
3.22; 3.22; 3.84; 3.61; 3.41; 3.22 | 0.641 |
| SECONDARY 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up |
3.22; 3.22; 3.84; 3.61; 3.41; 3.61 | 0.561 |
| SECONDARY Soleus H:M Ratio From Baseline to Post Intervention |
0.68; 0.65; 0.63; 0.67; 0.62; 0.64 | 0.233 |
| SECONDARY Soleus H:M Ratio From Baseline to Follow-Up |
0.67; 0.63; 0.65; 0.64; 0.62; 0.67 | 0.233 |
| SECONDARY Fibularis Longus H:M Ratio From Baseline to Post Intervention |
0.34; 0.29; 0.25; 0.27; 0.23; 0.28 | 0.030 sig |
| SECONDARY Fibularis Longus H:M Ratio From Baseline to Follow-Up |
0.30; 0.28; 0.28; 0.29; 0.23; 0.32 | 0.456 |
| SECONDARY Fibularis Longus Active Motor Threshold From Baseline to Post Intervention |
44; 38.38; 40.8; 45.12; 38.27; 42.2 | 0.919 |
| SECONDARY Fibularis Longus Active Motor Threshold From Baseline to Follow-Up |
44; 39.6; 41.22; 44.75; 40.26; 42.55 | 0.796 |
| SECONDARY Cortical Silent Period From Baseline to Post Intervention |
0.107; 0.125; 0.122; 0.085; 0.114; 0.091 | 0.701 |
| SECONDARY Cortical Silent Period From Baseline to Follow-Up |
0.088; 0.121; 0.114; 0.088; 0.096; 0.110 | 0.883 |
| SECONDARY Corticomotor Map Area From Baseline to Post Intervention |
13.43; 19.6; 21.8; 16.68; 21.55; 20.2 | 0.393 |
| SECONDARY Corticomotor Map Area From Baseline to Follow-Up |
14.3; 16.73; 20.0; 9.08; 16.73; 20.66 | 0.246 |
| SECONDARY Corticomotor Map Volume From Baseline to Post Intervention |
0.89; 1.2; 1.07; 0.80; 0.93; 1.05 | 0.703 |
| SECONDARY Corticomotor Map Volume From Baseline to Follow-Up |
0.91; 1.12; 0.99; 0.66; 0.74; 0.72 | 0.925 |
| SECONDARY Alpha Power Spectral Density From Baseline to Post Intervention |
0.739; 0.911; 0.755; 0.731; 0.990; 0.633 | 0.506 |
| SECONDARY Alpha Power Spectral Density From Baseline to Follow-Up |
0.669; 0.896; 0.707; 0.718; 0.805; 0.701 | 0.777 |
| SECONDARY Beta Power Spectral Density From Baseline to Post Intervention |
0.355; 0.480; 0.361; 0.336; 0.600; 0.354 | 0.738 |
| SECONDARY Beta Power Spectral Density From Baseline to Follow-Up |
0.310; 0.442; 0.338; 0.309; 0.429; 0.311 | 0.738 |
| SECONDARY Gamma Power Spectral Density From Baseline to Post Intervention |
0.116; 0.155; 0.123; 0.123; 0.172; 0.125 | 0.700 |
| SECONDARY Gamma Power Spectral Density From Baseline to Follow-Up |
0.109; 0.149; 0.120; 0.116; 0.166; 0.123 | 0.820 |
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.
Data sourced from ClinicalTrials.gov (NCT03418051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.