The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome

Study Overview
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Brief Summary
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The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus

Detailed Description
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This will be a single-blind, experimental study with two treatment groups. A total of 30 college athletes with PFPS and hallux valgus and majoring in long distance running or soccer, or recreational runners in Taipei metropolitan area will be recruited. A set of clinical examination will be conducted to rule out abnormal knee structures, pathologies, or injuries apart from PFPS. The lower extremity alignment as well as hip and knee kinematics during a step down test will be tracked using Noraxon's myoMOTION system. Muscle activation of the muscles controlling the hip and knee movements during the step down test will be recorded using TELEmyo DTS of Noraxon. Hallux valgus angle will be measured with surface markers on photographs. Knee pain level will be rated in a visual analog scale. The investigators will analyze the data with Statistical Product and Service Solutions (SPSS) for Windows. Repeated-measure ANOVAs will be used to examine group-by-time interaction on all the outcome variables. All significance level will be set at 0.05.

Official Title
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The Additional Effect of First Metatarsophalangeal Joint Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome

Conditions
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Patellofemoral Pain Syndrome, Hallux Valgus

Intervention / Treatment
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* Other: combined training
* Other: Proximal training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High physical activity level (running at least 5 times/week and at least 2 hours/time) Presenting anterior/retropatellar knee pain in the past 6 months At least two of the following activities provocated symptom: Prolonged sitting, ascending and/or descending stairs, squatting, kneeling, running, limping Not having any pathologies of knee joint (ligament tear, menisci injury, patellofemoral joint dislocation, tendinitis, bursitis…etc.) With hallux valgus angle>15° With 1st metatarsophalangeal joint instability 20 40 y/o Exclusion Criteria: Lower extremities osteoarthritis Systematic diseases such as rheumatoid arthritis, systemic lupus erythematosus, DM…etc. Lower extremities fracture history Surgical history of lower extremities Neurological pathology that would interfere with gait Hallux could not be corrected to neutral through passive correction Low back pain and/or sacroiliac joint dysfunction in the past six months Excessive femoral anteversion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined training group<br>Biomechanical taping will first being applied to the participants of the combined training group. They will be asked to perform following exercises in this session afterwards. As the treatment session goes on, a set of foot intrinsic muscle strengthening exercise and lower extremity neuromuscular exercise will be provided. | Other: combined training<br>* The whole intervention period will last for 6 weeks, 2 visits per week, 1 hour per visit in the Research Building Room 630 of National Yang Ming University. All programs will be under the supervision of a physiotherapist with 2-year experience individually. 1. Hallux valgus correction: 1.1 Joint alignment correction (Grade II joint mobilization, 10 times/set, 3 sets/visit) - 1st MTP joint distraction - Proximal talofibular joint anteroposterior glide - (Grade III joint mobilization if any restriction being found) 1.2 Biomechanical taping (using Dynamic taping, 1 time/ visit, keep the taping for 2 days minimum) 1.3 Foot intrinsic muscle strengthening (10 times/set for each exercise, 3 sets/visit): - Short foot exercise - Toespread out exercise - Heel-rise exercises 2. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 2.1 Single lunge 2.2 Stepping down 2.3 Vertical squat 2.4 Vertical jumping<br>* Other names: lower extremity neuromuscular exercises;|
| Active Comparator: Proximal training group<br>For participants of the proximal training group, only a set of lower extremity neuromuscular exercise will be provided. This set of exercises is designed to be the same as for participants of combined training group. | Other: Proximal training<br>* 1. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 1.1 Single lunge 1.2 Stepping down 1.3 Vertical squat 1.4 Vertical jumping All exercises will first start on firm surface without additional resistance/weight. Later, settings will be gradually shifted into on firm surface with resisted band from random direction, on a cushion with/ without resisted band, on a BOSU balance trainer. Progression are made every 2 weeks ideally, while adjustments may be taken into concern due to individual differences.<br>* Other names: lower extremity neuromuscular exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Displacement of femur in step-down test | displacement recorded in cm/BMI | changes from baseline and after 6 weeks of intervention | 
| Displacement of tibia in step-down test | displacement recorded in cm/BMI | changes from baseline and after 6 weeks of intervention | 
| Knee pain level | The level of knee pain during daily activities will be quantified with visual analogue scale. | changes from baseline and after 6 weeks of intervention | 
| Changes of pain-free running distance | The changes of pain-free running distance will be recorded in kilometers. | changes from baseline and after 6 weeks of intervention | 
| EMG amplitude of knee extensor | amplitude recorded in %MVC | changes from baseline and after 6 weeks of intervention | 
| EMG amplitude of knee flexor | amplitude recorded in %MVC | changes from baseline and after 6 weeks of intervention | 
| EMG amplitude of hip external rotator | amplitude recorded in %MVC | changes from baseline and after 6 weeks of intervention | 
| changes of the muscle activation time between vastus medialis oblique and vastus lateralis | changes of the muscle activation time recorded in second | changes from baseline and after 6 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tibiofemoral angle in relaxed standing | recorded in degree | changes from baseline and after 6 weeks of intervention | 
| Hallux valgus angle in relaxed standing | recorded in degree | changes from baseline and after 6 weeks of intervention | 
| Navicular drop | navicular position changes between sitting and relaxed standing, recording in cm | changes from baseline and after 6 weeks of intervention | 
| Arch height index | arch height in one leg standing, recording in the ratio of arch height and truncated foot length | changes from baseline and after 6 weeks of intervention | 
| Hip rotation angle in relaxed standing | recorded in degree | changes from baseline and after 6 weeks of intervention | 
| Knee rotation angle in relaxed standing | recorded in degree | changes from baseline and after 6 weeks of intervention |