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Trial registered on ANZCTR


Registration number
ACTRN12606000109505
Ethics application status
Approved
Date submitted
17/03/2006
Date registered
27/03/2006
Date last updated
7/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Comparing Two Different Knee Exercise Programmes in the management of Adolescents with Symptomatic Joint Hypermobility
Scientific title
A Randomised Controlled Trial Comparing Two Different Knee Exercise Programmes to reduce pain in Adolescents with Symptomatic knee Joint Hypermobility in the context of generalised joint hypermobility
Secondary ID [1] 273383 0
none
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypermobility 1074 0
Knee pain 1075 0
Condition category
Condition code
Musculoskeletal 1154 1154 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2 week observation period for all subjects will be followed by randomisation into one of two treatment groups. Each group will receive 8 weeks of physiotherapy treatment of around 45 minutes of supervised physiotherapy each week for 4 weeks then biweekly for another 4 weeks, directed at strengthening and improving control of the muscles around the knee, and advice on home exercises which they will be asked to do daily. The two groups will be doing exercises in different ranges of movement. Both types of exercises are not new and have already been in practice for the treatment of children with this condition.
Intervention code [1] 942 0
Treatment: Other
Comparator / control treatment
control period prior to treatment and 2 different types of treatment programmes
Control group
Active

Outcomes
Primary outcome [1] 1552 0
Reduction in pain using VAS scale of at least 20%
Timepoint [1] 1552 0
8 weeks and 3 months after the start of the intervention.
Secondary outcome [1] 2798 0
Reduction in fatigue using a VAS of at least 20%
Timepoint [1] 2798 0
8 weeks and 3 months after the start of the intervention.
Secondary outcome [2] 2799 0
Improvement in strength of the quadriceps using the paediatric quantitative measurement system.
Timepoint [2] 2799 0
8 weeks and 3 months after the start of the intervention .
Secondary outcome [3] 2800 0
Improvement in functional activities and quality of life using the childhood health assessment questionaire.
Timepoint [3] 2800 0
8 weeks and 3 months after the start of the intervention.
Secondary outcome [4] 2801 0
Decrease in resting joint hypermobility (hyperextension) of at least 2 degrees or 20 %.
Timepoint [4] 2801 0
8 weeks and 3 months after the start of the intervention.
Secondary outcome [5] 2802 0
Decrease in functional fatigue by time to ascend a flight of stairs.
Timepoint [5] 2802 0
8 weeks and 3 months after the start of the intervention.

Eligibility
Key inclusion criteria
Beighton score 5/9knee which hyperextend equal to or more than 10 degrees.
Minimum age
7 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous knee injury previous patella dislocations.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients all undergo a 2 week observation period after enrolment and are then randomised to one of two parallel active treatment groups. The patients are blinded to the treatment of the other group as they will not have any contact with them. The assessor is blinded as to which active treatment group the subject being assessed has been allocated to. The comparison between two treatments will be double blind randomised controlled but the within subject comparison of any treatment verses no treatment will be single blind only.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NSW
Recruitment hospital [1] 5917 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 13365 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 1261 0
Hospital
Name [1] 1261 0
Childrens Hospital at Westmead
Address [1] 1261 0
Locked Bag 4001, Westmead NSW 2145
Country [1] 1261 0
Australia
Funding source category [2] 1262 0
Other
Name [2] 1262 0
ConnecTed
Address [2] 1262 0
Locked Bag 4001, Westmead NSW 2145
Country [2] 1262 0
Australia
Primary sponsor type
Individual
Name
Verity Pacey
Address
Children's Hospital at Westmead Locked Bag 4001 Westmead NSW Australia 2145
Country
Australia
Secondary sponsor category [1] 1117 0
Individual
Name [1] 1117 0
Dr Louise Tofts
Address [1] 1117 0
Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW Australia 2145
Country [1] 1117 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2595 0
childrens hospital at westmead ethics
Ethics committee address [1] 2595 0
Ethics committee country [1] 2595 0
Australia
Date submitted for ethics approval [1] 2595 0
Approval date [1] 2595 0
01/12/2005
Ethics approval number [1] 2595 0
approved 2005

Summary
Brief summary
Joint Hypermobility Syndrome is a common but poorly recognised condition which mainly affects children. Joint hypermobility or double-jointedness can result in significant symptoms of pain, often described as growing pains, and symptoms of fatigue. This research study aims to find out what the best set of physiotherapy exercises is to reduce knee pain in individuals with joint hypermobility and pain. We are looking to recriut 40 teenagers aged 12-16 with knees that bend backward and are sore and give them 8 weeks of physiotherapy to see if it helps with the pain. Physiotherapy is the recommended treatment in this situation but reaserch to prove that it works has never been done, also different hospitals recommend different types of physiotherapy exercises and we will try and find out which ones work best or if there is no difference.
Trial website
Trial related presentations / publications
Pacey, V., Tofts, L., Adams, R., Munns, C., Nicholson, L. (2013). Exercise in children with joint hypermobility syndrome and knee pain: a randomised controlled trial comparing exercise into hypermobile versus neutral knee extension. Pediatric Rheumatology Online Journal, 11(1), 1-11
Open Access URL: http://ped-rheum.biomedcentral.com/articles/10.1186/1546-0096-11-30
Public notes
Attachments [1] 920 920 0 0

Contacts
Principal investigator
Name 35657 0
Dr Louise Tofts
Address 35657 0
Locked Bag 4001
Westmead NSW 2145
Country 35657 0
Australia
Phone 35657 0
+61 2 9845 2132
Fax 35657 0
Email 35657 0
louise.tofts@health.nsw.gov.au
Contact person for public queries
Name 10131 0
Dr Dr Verity Pacey
Address 10131 0
Physiotherapy Department
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 10131 0
Australia
Phone 10131 0
+61 2 98453369
Fax 10131 0
+61 2 98453685
Email 10131 0
verity.pacey@health.nsw.gov.au
Contact person for scientific queries
Name 1059 0
Dr Dr Louise Tofts
Address 1059 0
Children's Hospital Institute of Sports Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 1059 0
Australia
Phone 1059 0
+61 2 98450761
Fax 1059 0
+61 2 98450432
Email 1059 0
louise.tofts@health.nsw.gov.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