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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00662493
Other study ID # 020077
Secondary ID
Status Completed
Phase Phase 2
First received April 15, 2008
Last updated April 18, 2008
Start date March 2003
Est. completion date December 2005

Study information

Verified date April 2008
Source University of Melbourne
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 40 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Motor control retraining program
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 program
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

Locations

Country Name City State
Australia University of Melbourne Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
University of Melbourne National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary latency between the onset of VMO electromyographic activity relative to that of VL during stair ascent and stair descent measured using surface electrodes 6 weeks with 8 week followup No
Secondary Concentric and eccentric quadriceps muscle strength as assessed by isokinetic dynamometry 6 weeks with 8 week followup No
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