Knee PainPhase 2NCT00662493
A Comparison of Two Exercise Programs on Knee Motor Control
A Phase 2 study testing Quadriceps strengthening program in people with Knee Pain and Patellofemoral Pain, run by University of Melbourne at 1 site in Australia.
Trial summary
Pain at the front of the knee is a common condition treated by physical therapists. Treatment may consist of generalised strengthening exercises directed at the quadriceps muscle or specific retraining aimed at restoring motor control at the knee. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Pain, Patellofemoral Pain
- What is being tested?
- Quadriceps strengthening program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2003to Dec 2005
- Phase
- Phase 2
- 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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged between 16-40 years, with the upper age limit to reduce the likelihood of osteoarthritic changes in the patellofemoral joint
- a self-reported history of anterior or retropatellar knee pain with insidious onset of symptoms and with at least one episode of pain in the past 12 months where pain was aggravated by at least two of the following: prolonged sitting, stairs, squat, running, kneeling and hopping/jumping
- currently asymptomatic for at least 8 weeks prior to assessment
- delay in the onset of VMO EMG relative to that of VL of greater than 10 ms during either the ascent or descent of a stair stepping task
Who cannot join
- current knee pain
- history of knee surgery or other knee injury in previous 12 months
- physiotherapy treatment for knee pain in the past 12 months
- history of patellar dislocation/subluxation
- clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis and spinal referred pain
- current lower limb pathology affecting their ability to satisfactorily complete the testing or exercise protocol
- current use of non-steroidal anti-inflammatory or corticosteroid drugs
- inability to communicate and comprehend written or verbal instructions in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Specific Versus Generalised Quadriceps Exercise on Neural Control of the Vasti
Pain at the front of the knee is a common condition treated by physical therapists. Treatment may consist of generalised strengthening exercises directed at the quadriceps muscle or specific retraining aimed at restoring motor control at the knee. This study compared these two exercise programs in a group of people who were painfree at the time to evaluate their effect on motor control. It was hypothesised that only the motor retraining program would influence motor control at the knee.
- Conditions
- Knee Pain, Patellofemoral Pain
- Being tested
- Motor control retraining program, Quadriceps strengthening program
- Keywords
- knee pain, exercise, rehabilitation
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor control retraining programBehavioural
Specific retraining of VMO activation in a low-load situation,and progressed to integrate more functional positions. Use of dual channel biofeedback was incorporated
Quadriceps strengthening programBehavioural
4 exercises focused on quadriceps strengthening commencing at a resistance of 60% 1 repetition maximum. Each exercise was performed for 3 sets of 10 repetitions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Motor control retraining program Receives: Behavioral: Motor control retraining program; Behavioral: Quadriceps strengthening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
latency between the onset of VMO electromyographic activity relative to that of VL during stair ascent and stair descent measured using surface electrodes
Measured: 6 weeks with 8 week followup
Secondary outcomes (1)
Concentric and eccentric quadriceps muscle strength as assessed by isokinetic dynamometry
Measured: 6 weeks with 8 week followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMar 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- Kim L Bennell, PhD, Principal investigator, University of MelbourneKim Bennell, Principal investigator, University of MelbourneKim Bennell, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662493
- Sponsor's protocol ID
- 020077
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bennell K, Duncan M, Cowan S, McConnell J, Hodges P, Crossley K. Effects of vastus medialis oblique retraining versus general quadriceps strengthening on vasti onset. Med Sci Sports Exerc. 2010 May;42(5):856-64. doi: 10.1249/MSS.0b013e3181c12771.
PubMed 19997004
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Specific Versus Generalised Quadriceps Exercise on Neural Control of the Vasti
- ClinicalTrials.gov ID
- NCT00662493
- Acronym / sponsor ID
- 020077
- Conditions
- Knee Pain, Patellofemoral Pain
- Keywords
- knee pain, exercise, rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Mar 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain at the front of the knee is a common condition treated by physical therapists. Treatment may consist of generalised strengthening exercises directed at the quadriceps muscle or specific retraining aimed at restoring motor control at the knee. This study compared these two exercise programs in a group of people who were painfree at the time to evaluate their effect on motor control. It was hypothesised that only the motor retraining program would influence motor control at the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motor control retraining program, Behavioral: Quadriceps strengthening programMotor control retraining program |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- aged between 16-40 years, with the upper age limit to reduce the likelihood of osteoarthritic changes in the patellofemoral joint
- a self-reported history of anterior or retropatellar knee pain with insidious onset of symptoms and with at least one episode of pain in the past 12 months where pain was aggravated by at least two of the following: prolonged sitting, stairs, squat, running, kneeling and hopping/jumping
- currently asymptomatic for at least 8 weeks prior to assessment
- delay in the onset of VMO EMG relative to that of VL of greater than 10 ms during either the ascent or descent of a stair stepping task
Key exclusion criteria (8 listed)
- current knee pain
- history of knee surgery or other knee injury in previous 12 months
- physiotherapy treatment for knee pain in the past 12 months
- history of patellar dislocation/subluxation
- clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis and spinal referred pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor control retraining programSpecific retraining of VMO activation in a low-load situation,and progressed to integrate more functional positions. Use of dual channel biofeedback was incorporated | Behavioural | 1 |
| Quadriceps strengthening program4 exercises focused on quadriceps strengthening commencing at a resistance of 60% 1 repetition maximum. Each exercise was performed for 3 sets of 10 repetitions | Behavioural | 1 |
Primary outcome
latency between the onset of VMO electromyographic activity relative to that of VL during stair ascent and stair descent measured using surface electrodes
Time frame: 6 weeks with 8 week followup
1 secondary outcome
Concentric and eccentric quadriceps muscle strength as assessed by isokinetic dynamometry
Time frame: 6 weeks with 8 week followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
- Derived from this study: PubMed 19997004Bennell K, Duncan M, Cowan S, McConnell J, Hodges P, Crossley K. Effects of vastus medialis oblique retraining versus general quadriceps strengthening on vasti onset. Med Sci Sports Exerc. 2010 May;42(5):856-64. doi: 10.1249/MSS.0b013e3181c12771.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim L Bennell, PhD principal investigator
University of Melbourne
Kim Bennell principal investigator
University of Melbourne
Kim Bennell, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quadriceps strengthening program in people with Knee Pain and Patellofemoral Pain, run by University of Melbourne at 1 site in Australia.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 21 Apr 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
latency between the onset of VMO electromyographic activity relative to that of VL during stair ascent and stair descent measured using surface electrodes (time frame: 6 weeks with 8 week followup). 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 NCT00662493, which also lists 1 linked publication.
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 21 Apr 2008.