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

• ClinicalTrials.gov Identifier: NCT03468491
• Recruitment Status: Unknown
• First Posted: March 16, 2018
• Last Update Posted: June 1, 2018
• Sponsor: National Yang Ming University
• Information provided by (Responsible Party): National Yang Ming University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Patellofemoral Pain Syndrome; Hallux Valgus	Other: combined training; Other: Proximal training	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Additional Effect of First Metatarsophalangeal Joint Correction on Runners With First Ray Instability and Patellofemoral Pain Syndrome
• Estimated Study Start Date: June 20, 2018
• Estimated Primary Completion Date: September 30, 2018
• Estimated Study Completion Date: October 31, 2018

Arms and Interventions

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 Name: lower extremity neuromuscular exercises

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Wen-Yin Chen, PhD; +886 2826-7049; wychen@ym.edu.tw

Contact: Wan-Ling Yuan, BS; +886 0935806408; be945a7ts@gmail.com

Sponsors and Collaborators

National Yang Ming University

Investigators

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

More Information

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.

• Responsible Party: National Yang Ming University
• ClinicalTrials.gov Identifier: NCT03468491
• Other Study ID Numbers: YM106048F
• First Posted: March 16, 2018
• Last Update Posted: June 1, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Patellofemoral Pain Syndrome; Hallux Valgus; Syndrome; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Joint Diseases; Musculoskeletal Diseases; Foot Deformities