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Trial registered on ANZCTR


Registration number
ACTRN12605000775617
Ethics application status
Approved
Date submitted
1/12/2005
Date registered
2/12/2005
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Botulinum toxin Type A injection (Dysport®) to restore quadriceps muscle balance and improve chronic knee pain
Scientific title
A double blind randomized controlled trial of the efficacy of Botulinum toxin Type A injection (Dysport®) to restore quadriceps muscle balance in patients with chronic patello-femoral pain syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic anterior knee pain? 931 0
Condition category
Condition code
Musculoskeletal 1000 1000 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Single occasion intramuscular injection of Botulinum toxin Type A injection (500U Dysport®) to distal third of vastus lateralis [VL] muscle. 2. Exercise programme for knee extensor muscles
Intervention code [1] 784 0
Rehabilitation
Comparator / control treatment
1. Single occasion intramuscular injection of 500U saline (placebo). 2. Exercise programme for knee extensor muscles
Control group
Placebo

Outcomes
Primary outcome [1] 1331 0
Self-reported knee related disability and quality of life [Anterior Knee Pain Scale]
Timepoint [1] 1331 0
Comparison of AKPS scores at 12 week and 24 weeks with average of 3 baseline measures
Primary outcome [2] 1332 0
Timing of muscle onsets of VM/VL and ratio of VL:VM amplitude during a standardized stepping task [EMG]?
Timepoint [2] 1332 0
Comparison of timing of onsets at 12 week and 24 weeks with average of 3 baseline measures
Secondary outcome [1] 2375 0
Isometric knee extension force at 30° and 90° knee flexion [digital force dynamometry].
Timepoint [1] 2375 0
At 2, 6, 12, 18 and 24 weeks post injection, final measures at 1 year post entry to study.
Secondary outcome [2] 2376 0
Patella congruence and VM/VL cross sectional area [CT imaging]
Timepoint [2] 2376 0
At 12 weeks compared with baseline measures.

Eligibility
Key inclusion criteria
Anterior or retropatellar pain on at least two of the following: prolonged sitting, stairs, squat, running, kneeling and hopping/jumping unrelated to a recent traumatic incident no surgical intervention (arthroscopic investigation or menisectomy allowed).
Minimum age
15 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of recurrent patella dislocation/subluxationClinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patello-femoral complex, or patellar tendon pathology Radiographically determined osteoarthrotic changes of the PFJ Obesity BMI >30Previous BTXA injection within 3 months or any history of adverse reaction to BTXADisorders producing disturbed neuromuscular transmission (eg.myasthenia gravis)Concurrent use of aminoglycosides (potential for interaction with BTXA)History of infectious diseases or active rheumatoid arthritis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Same volume colourless solution drawn up by admin assistant and provided to blinded physician for injection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence to allocate subjects. Block randomisation is used to ensure approximately equal in trial numbers at each time point.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1098 0
Charities/Societies/Foundations
Name [1] 1098 0
Raine Medical Research Foundation
Address [1] 1098 0
Raine Medical Research Foundation
Suite 24, Hollywood Soecialist Centre
95 Monash Ave, Nedlands, WA 6009
Country [1] 1098 0
Australia
Funding source category [2] 2670 0
Commercial sector/Industry
Name [2] 2670 0
Ipsen Pharmaceuticals
Address [2] 2670 0
Suite 6,40 Montclair Ave
Glen Waverley 3150
Country [2] 2670 0
Australia
Primary sponsor type
Individual
Name
Dr BJ Singer, School of Surgery and Pathology, The University of Western AustraliaMedical Research Foundation Building, Level 2, Rear 50 Murray Street, Perth, WA 6000
Address
Level 2, MRF Building., Rear 50, Murray Street, Perth, Western Australia 6000
Country
Australia
Secondary sponsor category [1] 960 0
Individual
Name [1] 960 0
Professor KP Singer
Address [1] 960 0
School of Surgery and Pathology
The University of Western Australia
Country [1] 960 0
Australia
Secondary sponsor category [2] 961 0
Individual
Name [2] 961 0
Dr Peter Silbert
Address [2] 961 0
Department of Neurology
Royal Perth Hospital
Country [2] 961 0
Australia
Secondary sponsor category [3] 962 0
Individual
Name [3] 962 0
Dr John Dunne
Address [3] 962 0
Department of Neurology
Royal Perth Hospital
Country [3] 962 0
Australia
Secondary sponsor category [4] 963 0
Individual
Name [4] 963 0
Dr Swithin Song
Address [4] 963 0
Department of Radiology
Royal Perth Hospital
Country [4] 963 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2400 0
Royal Perth Hospital
Ethics committee address [1] 2400 0
Perth, Western Australia
Ethics committee country [1] 2400 0
Australia
Date submitted for ethics approval [1] 2400 0
Approval date [1] 2400 0
07/02/2006
Ethics approval number [1] 2400 0
2005/096

Summary
Brief summary
Abnormal tracking of the patella during knee joint movement, associated with imbalance of the pull of the inner quadriceps muscle (VM) and the outer quadriceps muscles (VL), has been proposed as a primary factor in anterior knee pain. Botulinum toxin (BTXA) can be used to reduce the relative overactivity in the VL muscle in addition to an exercise programme to strengthen the VM muscle in subjects with chronic anterior knee pain who had failed conservative management. We hypothesise that the combination of these therapies (BTXA and specific exercise for VM muscle control) has the potential to facilitate restoration of normal patello-femoral joint mechanics, particularly by restoring timing of onset of the VM muscle compared with VL, and consequently to reduce anterior knee pain and associated disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35362 0
Address 35362 0
Country 35362 0
Phone 35362 0
Fax 35362 0
Email 35362 0
Contact person for public queries
Name 9973 0
Dr Barbara Singer
Address 9973 0
School of Surgery and Pathology
The University of Western Australia
Level 2
Medical Research Foundation Building
Rear 50 Murray Street
Perth WA 6000
Country 9973 0
Australia
Phone 9973 0
+61 8 92240229
Fax 9973 0
+61 8 92240204
Email 9973 0
bjs@cms.uwa.edu.au
Contact person for scientific queries
Name 901 0
Dr Barbara Singer
Address 901 0
School of Surgery and Pathology
The University of Western Australia
Level 2
Medical Research Foundation Building
Rear 50 Murray Street
Perth WA 6000
Country 901 0
Australia
Phone 901 0
+61 8 92240229
Fax 901 0
+61 8 92240204
Email 901 0
bjs@cms.uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary