Comparisons of Mechanical Properties of Tendon Structures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00451087
First received: March 22, 2007
Last updated: January 28, 2008
Last verified: December 2006
  Purpose

We assume the etiology of patellofemoral pain syndrome is related to mechanical properties of tendon structures of the vastus medialis obliquus and vastus lateralis. Consequently, we will measure the electromechanical delay and some viscoelastic parameters of the two muscles. Besides, we will also investigate the effects of exercise training to the mechanical properties of the muscles.


Condition Intervention Phase
Patellofemoral Pain Syndrome
Procedure: leg press training
Procedure: isokinetic training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 1 Study: Comparison of Electromechanical Delay Phase 2 Study: Research in Viscoelasticity of Tendon Structures Phase 3 Study: Effects of Exercise Training in the Mechanical Properties

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • electromechanical delay [ Time Frame: minisecond ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quadriceps muscle force [ Time Frame: second ] [ Designated as safety issue: No ]
  • the displacement of deep aponeurosis of vasti muscles [ Time Frame: second ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2006
Estimated Study Completion Date: September 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: leg press training
quadriceps muscle strengthening. 30min/ 3times/ week
Active Comparator: 2 Procedure: isokinetic training
quadriceps muscle training. 30 min/ 3 times/ week

Detailed Description:

Patellofemoral pain syndrome (PFPS) is a common knee disorder. From the literature review, one may find inconsistent results among different research or clinical studies on the effect of therapeutic exercise for the patients with PFPS. A possible reason for the disagreement might be lack of a clear etiology of patellofemoral pain. At present, the most widely accepted concept for the genesis of patellofemoral pain is abnormal lateral tracking of the patella. One factor that causes this maltracking is soft tissue imbalance around the patella. Previous studies demonstrating the inconsistency of the amplitude of muscle activity and the timing of muscle firing for vastus medialis obliquus (VMO) and vastus lateralis (VL) may contribute to the imbalance of soft tissue. Another neuromuscular condition, however, the electromechanical delay of VMO and VL in patents with PFPS was not investigated extensively. We hypothesized that people with PFPS would have longer electromechanical delay of VMO than that of VL. The objective of this three-year project is to compare the electromechanical delay of VMO with that of VL in people with PFPS for the first year. In the second year, we will further investigate the viscoelastic properties of tendon structures, the key components induced this electromechanical delay, of VMO and VL in vivo. In the last year, we will research the effect of an exercise program on the mechanical properties of VMO and VL in people with PFPS.We expect to recruit 30 patients with PFPS as an experimental group and 30 healthy individuals as a control group in the both first and second years. In the third year, we will recruit 60 patients with PFPS, 30 of them to receive a specific exercise program and the others are in the control group.

The evoked electromechanical delay of VMO is defined as the time interval between the time when VMO receiving an electrical stimulation and the onset time of patellar movement due to the VMO contraction. The viscoelastic properties of tendon structures are investigated by an ultrasonographic study under voluntary contraction conditions. The torque output during isometric knee extension at 80° of flexion is measured by a dynamometer. The subject is instructed to produce a gradually increasing force from relaxed status to maximal voluntary contraction within 5 seconds, followed by a gradual relaxation also within 5 seconds. Simultaneously, the elongation of the deep aponeurosis of the VMO or VL is caught by the ultrasonic image which is synchronized with the torque signal by a clock timer for subsequent analysis. The stiffness, Young's modulus and hysteresis of the tendon structures are calculated to represent its viscoelastic properties.

Finally, the subject is prescribed an 8-week exercise program by EN-dynamic machine to perform knee extension from 45° to 0° of flexion. The training outcome is assessed with electromechanical delay of VMO and VL. And we will also investigate the effect of the exercise program on the mechanical properties of tendon structures.

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Below 50 years old.
  2. Subjects have at least two of five conditions of knee pain: to squat down, to go or down stairs, to keep prolong sitting position, to be palpated the joint cartilage of patella, to be test by Clark sign.
  3. Subjects have the symptoms for 3 months at least.

Exclusion Criteria:

  1. Subjects have the other knee disorder in addition to PFPS.
  2. Subjects had ever received operations of knee in past 3 months.
  3. Subjects have neurological disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00451087

Contacts
Contact: Mei-Hwa Jan, Master 886-2-33228138 mhjan@ntu.edu.tw

Locations
Taiwan
Kinesiology Laboratory Recruiting
Taipei, Taiwan, 100
Contact: Mei-Hwa Jan, Master    886-2-33228138    mhjan@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Mei-Hwa Jan, Master School and Graduate Institude of Physical Therapy,NTU
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mei-Hwa Jan / Associate Professor, School and Graduate Institute of Physical Therapy
ClinicalTrials.gov Identifier: NCT00451087     History of Changes
Other Study ID Numbers: 9561703048
Study First Received: March 22, 2007
Last Updated: January 28, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
mechanical properties
electromechanical delay
viscoelasticity
VMO
patellofemoral pain syndrome

Additional relevant MeSH terms:
Somatoform Disorders
Patellofemoral Pain Syndrome
Mental Disorders
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 26, 2014