Clinical trial NCT03468491: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Hallux Valgus
Keywords: Patellofemoral pain syndrome
Runner
First ray instability
Lower extremity closed chain exercise
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Displacement of femur in step-down test
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Displacement of tibia in step-down test
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Knee pain level
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Changes of pain-free running distance
timeFrame: changes from baseline and after 6 weeks of intervention
measure: EMG amplitude of knee extensor
timeFrame: changes from baseline and after 6 weeks of intervention
measure: EMG amplitude of knee flexor
timeFrame: changes from baseline and after 6 weeks of intervention
measure: EMG amplitude of hip external rotator
timeFrame: changes from baseline and after 6 weeks of intervention
measure: changes of the muscle activation time between vastus medialis oblique and vastus lateralis
timeFrame: changes from baseline and after 6 weeks of intervention
Secondary outcomes:
measure: Tibiofemoral angle in relaxed standing
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Hallux valgus angle in relaxed standing
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Navicular drop
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Arch height index
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Hip rotation angle in relaxed standing
timeFrame: changes from baseline and after 6 weeks of intervention
measure: Knee rotation angle in relaxed standing
timeFrame: changes from baseline and after 6 weeks of intervention
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Yng Ming University
state: 北投區
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: be945a7ts@gmail.com Chen, PhD
role: STUDY_DIRECTOR
References:
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.