NCT03468491

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

August 13, 2024

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

February 6, 2018

Last Update Submit

August 12, 2024

Conditions

Keywords

Patellofemoral pain syndromeRunnerFirst ray instabilityLower extremity closed chain exercise

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (6)

  • 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

  • Navicular drop

    changes from baseline and after 6 weeks of intervention

  • Arch height index

    changes from baseline and after 6 weeks of intervention

  • Hip rotation angle in relaxed standing

    changes from baseline and after 6 weeks of intervention

  • +1 more secondary outcomes

Study Arms (2)

Combined training group

EXPERIMENTAL

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

Proximal training group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: hallux valgus correction, lower extremity neuromuscular exercises
Combined training group

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.

Also known as: lower extremity neuromuscular exercises
Proximal training group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • \~40 y/o

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yng Ming University

Taipei, 北投區, 112, Taiwan

Location

Related 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. No abstract available.

    PMID: 20195028BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain SyndromeHallux Valgus

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesFoot Deformities

Study Officials

  • be945a7ts@gmail.com Chen, PhD

    National Yang Ming Chiao Tung University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

March 16, 2018

Study Start

June 1, 2018

Primary Completion

September 30, 2018

Study Completion

January 30, 2019

Last Updated

August 13, 2024

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations