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Completed

NCT Number: NCT03468491

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

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

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Key information

Conditions

Patellofemoral Pain Syndrome Foot Deformities Hallux Valgus Joint Diseases Musculoskeletal Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yng Ming University

Taipei, 北投區, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined training

Other

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

Other names: hallux valgus correction, lower extremity neuromuscular exercises

Proximal training

Other
  • 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.

Other names: lower extremity neuromuscular exercises

Primary outcomes

  1. Displacement of femur in step-down test

    Time frame: changes from baseline and after 6 weeks of intervention

    displacement recorded in cm/BMI

  2. Displacement of tibia in step-down test

    Time frame: changes from baseline and after 6 weeks of intervention

    displacement recorded in cm/BMI

  3. Knee pain level

    Time frame: changes from baseline and after 6 weeks of intervention

    The level of knee pain during daily activities will be quantified with visual analogue scale.

  4. Changes of pain-free running distance

    Time frame: changes from baseline and after 6 weeks of intervention

    The changes of pain-free running distance will be recorded in kilometers.

  5. EMG amplitude of knee extensor

    Time frame: changes from baseline and after 6 weeks of intervention

    amplitude recorded in %MVC

  6. EMG amplitude of knee flexor

    Time frame: changes from baseline and after 6 weeks of intervention

    amplitude recorded in %MVC

  7. EMG amplitude of hip external rotator

    Time frame: changes from baseline and after 6 weeks of intervention

    amplitude recorded in %MVC

  8. changes of the muscle activation time between vastus medialis oblique and vastus lateralis

    Time frame: changes from baseline and after 6 weeks of intervention

    changes of the muscle activation time recorded in second

Secondary outcomes

  1. Tibiofemoral angle in relaxed standing

    Time frame: changes from baseline and after 6 weeks of intervention

    recorded in degree

  2. Hallux valgus angle in relaxed standing

    Time frame: changes from baseline and after 6 weeks of intervention

    recorded in degree

  3. Navicular drop

    Time frame: changes from baseline and after 6 weeks of intervention

    navicular position changes between sitting and relaxed standing, recording in cm

  4. Arch height index

    Time frame: changes from baseline and after 6 weeks of intervention

    arch height in one leg standing, recording in the ratio of arch height and truncated foot length

  5. Hip rotation angle in relaxed standing

    Time frame: changes from baseline and after 6 weeks of intervention

    recorded in degree

  6. Knee rotation angle in relaxed standing

    Time frame: changes from baseline and after 6 weeks of intervention

    recorded in degree

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 16, 2018
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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