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

The Additional Effect of First Metatarsophalangeal Joint 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

Study Overview

• Status: Unknown
• Conditions: Patellofemoral Pain Syndrome; Hallux Valgus
• Intervention / Treatment: Other: combined training; Other: Proximal training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen-Yin Chen, PhD; Phone Number: +886 2826-7049; Email: wychen@ym.edu.tw
• Study Contact Backup: Name: Wan-Ling Yuan, BS; Phone Number: +886 0935806408; Email: be945a7ts@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined training group; 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.	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; Other Names: hallux valgus correction; lower extremity neuromuscular exercises
Active Comparator: Proximal training group; 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.	Other: 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.; Other Names: lower extremity neuromuscular exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Displacement of femur in step-down test	displacement recorded in cm/BMI	changes from baseline and after 6 weeks of intervention
Displacement of tibia in step-down test	displacement recorded in cm/BMI	changes from baseline and after 6 weeks of intervention
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
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
EMG amplitude of knee extensor	amplitude recorded in %MVC	changes from baseline and after 6 weeks of intervention
EMG amplitude of knee flexor	amplitude recorded in %MVC	changes from baseline and after 6 weeks of intervention
EMG amplitude of hip external rotator	amplitude recorded in %MVC	changes from baseline and after 6 weeks of intervention
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tibiofemoral angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention
Hallux valgus angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention
Navicular drop	navicular position changes between sitting and relaxed standing, recording in cm	changes from baseline and after 6 weeks of intervention
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
Hip rotation angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention
Knee rotation angle in relaxed standing	recorded in degree	changes from baseline and after 6 weeks of intervention

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Study Director: be945a7ts@gmail.com Chen, PhD, National Yang Ming University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2018
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): October 31, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: March 11, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome; Hallux Valgus
• Other Study ID Numbers: YM106048F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No