The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
The Additional Effect of First Metatarsophalangeal Joint Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
1 other identifier
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedAugust 13, 2024
May 1, 2018
4 months
February 6, 2018
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (6)
Tibiofemoral angle in relaxed standing
changes from baseline and after 6 weeks of intervention
Hallux valgus angle in relaxed standing
changes from baseline and after 6 weeks of intervention
Navicular drop
changes from baseline and after 6 weeks of intervention
Arch height index
changes from baseline and after 6 weeks of intervention
Hip rotation angle in relaxed standing
changes from baseline and after 6 weeks of intervention
- +1 more secondary outcomes
Study Arms (2)
Combined training group
EXPERIMENTALBiomechanical 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.
Proximal training group
ACTIVE COMPARATORFor 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
- \~40 y/o
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Yng Ming University
Taipei, 北投區, 112, Taiwan
Related Publications (1)
Davis IS, Powers CM. Patellofemoral pain syndrome: proximal, distal, and local factors, an international retreat, April 30-May 2, 2009, Fells Point, Baltimore, MD. J Orthop Sports Phys Ther. 2010 Mar;40(3):A1-16. doi: 10.2519/jospt.2010.0302. No abstract available.
PMID: 20195028BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
be945a7ts@gmail.com Chen, PhD
National Yang Ming Chiao Tung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2018
First Posted
March 16, 2018
Study Start
June 1, 2018
Primary Completion
September 30, 2018
Study Completion
January 30, 2019
Last Updated
August 13, 2024
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share