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

Primary Purpose

Patellofemoral Pain Syndrome, Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
combined training
Proximal training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Combined training group

    Proximal training group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Tibiofemoral angle in relaxed standing
    recorded in degree
    Hallux valgus angle in relaxed standing
    recorded in degree
    Navicular drop
    navicular position changes between sitting and relaxed standing, recording in cm
    Arch height index
    arch height in one leg standing, recording in the ratio of arch height and truncated foot length
    Hip rotation angle in relaxed standing
    recorded in degree
    Knee rotation angle in relaxed standing
    recorded in degree

    Full Information

    First Posted
    February 6, 2018
    Last Updated
    May 31, 2018
    Sponsor
    National Yang Ming University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03468491
    Brief Title
    The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
    Official Title
    The Additional Effect of First Metatarsophalangeal Joint Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 20, 2018 (Anticipated)
    Primary Completion Date
    September 30, 2018 (Anticipated)
    Study Completion Date
    October 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Yang Ming University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellofemoral Pain Syndrome, Hallux Valgus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined training group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Proximal training group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    combined training
    Other Intervention Name(s)
    hallux valgus correction, lower extremity neuromuscular exercises
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Proximal training
    Other Intervention Name(s)
    lower extremity neuromuscular exercises
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Displacement of femur in step-down test
    Description
    displacement recorded in cm/BMI
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Displacement of tibia in step-down test
    Description
    displacement recorded in cm/BMI
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Knee pain level
    Description
    The level of knee pain during daily activities will be quantified with visual analogue scale.
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Changes of pain-free running distance
    Description
    The changes of pain-free running distance will be recorded in kilometers.
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    EMG amplitude of knee extensor
    Description
    amplitude recorded in %MVC
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    EMG amplitude of knee flexor
    Description
    amplitude recorded in %MVC
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    EMG amplitude of hip external rotator
    Description
    amplitude recorded in %MVC
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    changes of the muscle activation time between vastus medialis oblique and vastus lateralis
    Description
    changes of the muscle activation time recorded in second
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Secondary Outcome Measure Information:
    Title
    Tibiofemoral angle in relaxed standing
    Description
    recorded in degree
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Hallux valgus angle in relaxed standing
    Description
    recorded in degree
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Navicular drop
    Description
    navicular position changes between sitting and relaxed standing, recording in cm
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Arch height index
    Description
    arch height in one leg standing, recording in the ratio of arch height and truncated foot length
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Hip rotation angle in relaxed standing
    Description
    recorded in degree
    Time Frame
    changes from baseline and after 6 weeks of intervention
    Title
    Knee rotation angle in relaxed standing
    Description
    recorded in degree
    Time Frame
    changes from baseline and after 6 weeks of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wen-Yin Chen, PhD
    Phone
    +886 2826-7049
    Email
    wychen@ym.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wan-Ling Yuan, BS
    Phone
    +886 0935806408
    Email
    be945a7ts@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    be945a7ts@gmail.com Chen, PhD
    Organizational Affiliation
    National Yang Ming University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20195028
    Citation
    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.
    Results Reference
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    The Additional Effect of Hallux Valgus Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome

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