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Clinical Trials/NCT03468491
NCT03468491
Completed
Not Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country30 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Pain Syndrome
Sponsor
National Yang Ming Chiao Tung University
Enrollment
30
Locations
1
Primary Endpoint
Displacement of femur in step-down test
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
January 30, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Displacement of femur in step-down test

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

displacement recorded in cm/BMI

EMG amplitude of knee extensor

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

amplitude recorded in %MVC

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

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.

Displacement of tibia in step-down test

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

displacement recorded in cm/BMI

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.

EMG amplitude of hip external rotator

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

amplitude recorded in %MVC

EMG amplitude of knee flexor

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

amplitude recorded in %MVC

Secondary Outcomes

  • 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)
  • Hip rotation angle in relaxed standing(changes from baseline and after 6 weeks of intervention)
  • Arch height index(changes from baseline and after 6 weeks of intervention)
  • Navicular drop(changes from baseline and after 6 weeks of intervention)
  • Knee rotation angle in relaxed standing(changes from baseline and after 6 weeks of intervention)

Study Sites (1)

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