AzTrials
AzTrials

Patellofemoral Pain SyndromePhase 1NCT00451087

Comparisons of Mechanical Properties of Tendon Structures

A Phase 1 study testing leg press training and isokinetic training in people with Patellofemoral Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 49 yearsHealthy volunteers can take part
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
leg press training and isokinetic training
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTaiwan
Study dates
Dec 2006to Sep 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mei-Hwa Jan, Master contact

886-2-33228138

mhjan@ntu.edu.tw

Taiwan1 site, 1 recruiting
  • Kinesiology Laboratory

    Taipei, 100

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

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
leg press training, isokinetic training
Keywords
mechanical properties, electromechanical delay, viscoelasticity, VMO, patellofemoral pain syndrome
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • leg press trainingProcedure or surgery

    quadriceps muscle strengthening. 30min/ 3times/ week

  • isokinetic trainingProcedure or surgery

    quadriceps muscle training. 30 min/ 3 times/ week

Study groups in NCT00451087
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Procedure: leg press training
2Active comparatorNot described
Receives: Procedure: isokinetic training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. electromechanical delay

    Measured: minisecond

Secondary outcomes (2)
  1. quadriceps muscle force

    Measured: second

  2. the displacement of deep aponeurosis of vasti muscles

    Measured: second

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionMar 2007
  4. Study completionSep 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00451087
Sponsor's protocol ID
9561703048
Status last verified
Dec 2006
First submitted
22 Mar 2007
Last updated
30 Jan 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12098160
  • 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.

    PubMed 10638375
  • 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.

    PubMed 22951377

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing leg press training and isokinetic training in people with Patellofemoral Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mei-Hwa Jan, Master (886-2-33228138, mhjan@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

electromechanical delay (time frame: minisecond). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00451087, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in