Comparisons of Mechanical Properties of Tendon Structures
Primary Purpose
Patellofemoral Pain Syndrome
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
leg press training
isokinetic training
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring mechanical properties, electromechanical delay, viscoelasticity, VMO, patellofemoral pain syndrome
Eligibility Criteria
Inclusion Criteria:
- Below 50 years old.
- 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.
- Subjects have the symptoms for 3 months at least.
Exclusion Criteria:
- Subjects have the other knee disorder in addition to PFPS.
- Subjects had ever received operations of knee in past 3 months.
- Subjects have neurological disease.
Sites / Locations
- Kinesiology LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
electromechanical delay
Secondary Outcome Measures
quadriceps muscle force
the displacement of deep aponeurosis of vasti muscles
Full Information
NCT ID
NCT00451087
First Posted
March 22, 2007
Last Updated
January 28, 2008
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00451087
Brief Title
Comparisons of Mechanical Properties of Tendon Structures
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
mechanical properties, electromechanical delay, viscoelasticity, VMO, patellofemoral pain syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
leg press training
Intervention Description
quadriceps muscle strengthening. 30min/ 3times/ week
Intervention Type
Procedure
Intervention Name(s)
isokinetic training
Intervention Description
quadriceps muscle training. 30 min/ 3 times/ week
Primary Outcome Measure Information:
Title
electromechanical delay
Time Frame
minisecond
Secondary Outcome Measure Information:
Title
quadriceps muscle force
Time Frame
second
Title
the displacement of deep aponeurosis of vasti muscles
Time Frame
second
10. Eligibility
Sex
All
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Below 50 years old.
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.
Subjects have the symptoms for 3 months at least.
Exclusion Criteria:
Subjects have the other knee disorder in addition to PFPS.
Subjects had ever received operations of knee in past 3 months.
Subjects have neurological disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Hwa Jan, Master
Phone
886-2-33228138
Email
mhjan@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Hwa Jan, Master
Organizational Affiliation
School and Graduate Institude of Physical Therapy,NTU
Official's Role
Study Director
Facility Information:
Facility Name
Kinesiology Laboratory
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei-Hwa Jan, Master
Phone
886-2-33228138
Email
mhjan@ntu.edu.tw
12. IPD Sharing Statement
Citations:
PubMed Identifier
12098160
Citation
Cowan SM, Hodges PW, Bennell KL, Crossley KM. Altered vastii recruitment when people with patellofemoral pain syndrome complete a postural task. Arch Phys Med Rehabil. 2002 Jul;83(7):989-95. doi: 10.1053/apmr.2002.33234.
Results Reference
background
PubMed Identifier
10638375
Citation
Kubo K, Kanehisa H, Kawakami Y, Fukunaga T. Elastic properties of muscle-tendon complex in long-distance runners. Eur J Appl Physiol. 2000 Feb;81(3):181-7. doi: 10.1007/s004210050028.
Results Reference
result
PubMed Identifier
22951377
Citation
Chen HY, Chien CC, Wu SK, Liau JJ, Jan MH. Electromechanical delay of the vastus medialis obliquus and vastus lateralis in individuals with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2012 Sep;42(9):791-6. doi: 10.2519/jospt.2012.3973. Epub 2012 Aug 2.
Results Reference
derived
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Comparisons of Mechanical Properties of Tendon Structures
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