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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03468491
• Other study ID #: YM106048F
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2018
• Source: National Yang Ming University
• Contact: Wen-Yin Chen, PhD
• Phone: +886 2826-7049
• Email: wychen[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus
• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• combined training
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
• Proximal training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Displacement of femur in step-down test	displacement recorded in cm/BMI	changes from baseline and after 6 weeks of intervention
Primary	Displacement of tibia in step-down test	displacement recorded in cm/BMI	changes from baseline and after 6 weeks of intervention
Primary	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
Primary	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
Primary	EMG amplitude of knee extensor	amplitude recorded in %MVC	changes from baseline and after 6 weeks of intervention
Primary	EMG amplitude of knee flexor	amplitude recorded in %MVC	changes from baseline and after 6 weeks of intervention
Primary	EMG amplitude of hip external rotator	amplitude recorded in %MVC	changes from baseline and after 6 weeks of intervention
Primary	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	Tibiofemoral angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention
Secondary	Hallux valgus angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention
Secondary	Navicular drop	navicular position changes between sitting and relaxed standing, recording in cm	changes from baseline and after 6 weeks of intervention
Secondary	Arch height index	arch height in one leg standing, recording in the ratio of arch height and truncated foot length	changes from baseline and after 6 weeks of intervention
Secondary	Hip rotation angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention
Secondary	Knee rotation angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention