Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000871741
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
6/08/2013
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of an in-season rehabilitation program on patellar tendon pain in jumping athletes.
Scientific title
Do in-season athletes with jumper’s knee who complete isometric or isotonic rehabilitation exercises have an improvement in patellar tendon pain?
Secondary ID [1] 282927 0
nil known
Universal Trial Number (UTN)
U1111-1146-0902
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellar tendinopathy (jumper's knee) 289725 0
Condition category
Condition code
Musculoskeletal 290054 290054 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290078 290078 0 0
Physiotherapy
Injuries and Accidents 290080 290080 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two active intervention groups
Group 1: Isometric exercises: 4 weeks. 4x per week, 5x 45 second isometric contraction of both legs on a leg extension machine with a knee joint angle of 60 degrees. 80% Maximal Voluntary Contraction, with a 2.5% progressive overload of RM per week.
Rest period after completing both legs is 15 seconds. Total duration of exercise session including 5 minute warm up is 15 minutes.

Group 2: Isotonic exercises: 4 weeks. 4x per week, 4x 8 repetitions of isotonic contractions of both legs on a leg extension machine through range of motion (three second concentric phase immediately followed by a four second eccentric phase). 80% of 8RM, with a 2.5% progressive overload of RM per week.
Rest period after completing both legs is 15 seconds. Total duration of exercise session including 5 minute warm up is 15 minutes.
Participants will receive (smart phone) audio instructions to listen to during their exercises.

Participants will be asked to fill out an exercise diary and will be followed-up weekly at the venue of the matches of their team to improve adherence.
Intervention code [1] 287617 0
Treatment: Other
Intervention code [2] 287629 0
Rehabilitation
Comparator / control treatment
Group 1 (Isometric exercises) will be compared to Group 2 (Isotonic exercises).
Control group
Active

Outcomes
Primary outcome [1] 290120 0
Pain during a Single Leg Decline Squat score on a Numeric Rating Scale (0 -10)
Timepoint [1] 290120 0
Baseline, 1, 2, 3 and 4 weeks after intervention commencement
Secondary outcome [1] 303971 0
Victorian Institute of Sports Assessment–Patella (VISA-P) score (0-100)
Timepoint [1] 303971 0
Baseline, and 4 weeks after intervention commencement
Secondary outcome [2] 303972 0
(a subset of participants) Transcranial magnetic stimulation (TMS) allows non-invasive assessment of the cortical representation of muscles. The quadriceps muscle representation (area and excitability) will be compared from baseline and at 4 weeks in both groups.
Timepoint [2] 303972 0
Baseline and 4 weeks after intervention commencement
Secondary outcome [3] 303984 0
Ultrasound Tissue Characterization: Ultrasound imaging of the patellar tendon
Timepoint [3] 303984 0
Baseline, 4 weeks after intervention commencement

Eligibility
Key inclusion criteria
- Athletes currently playing jumping sports at least 3 times per week
- Clinical diagnosis of patellar tendinopathy by an experienced physiotherpist
-Focal patellar tendon pain at inferior or superior pole of patella
- History of exercise associated knee pain at the inferior or superior pole
Minimum age
16 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other knee pathology
- Previous patellar tendon rupture
- Inflammatory disorders
- Metabolic bone diseases
- Type II diabetes
- Familial hypercholesterolaemia
- Other chronic pain conditions

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)
Researchers of this study will be present at game or training days of volleyball, basketball and Australian rules football teams. Athletes who are willing to participate in the study, will be screened on in- and exclusion criteria. Subsequently, they will be registered in the trial and allocated to a treatment.


Participants will be allocated to a treatment by fully opaque envelopes randomization. After registration to participate in the trial, a participant has to draw an envelope with one of the two interventions in it.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Forty envelopes are randomised using a randomisation table created by computer software (20 each group).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There are no data on which to base an a priori power analysis, therefore a post-hoc power analysis will be conducted after first round of inclusion (2 weeks), and if needed another round of inclusion will follow.
Dummy data suggest that if the pain score change by 2.5 points in one group and 1 in the other group (SD 1 both groups, we have no data to indicate if one group is superior to the other), and effect size of .75 is achieved and a sample size of 18 is required (alpha .05, beta 0.95).

The statistical methods described below will be reviewed by a statistician.
For each outcome measure, independent t-test will be used to test the differences between groups at baseline. Four week week outcomes will be analysed with a mixed factor ANOVA (group x time (0 and 4 weeks)).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2013
Actual
3/08/2013
Date of last participant enrolment
Anticipated
31/05/2014
Actual
1/07/2015
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment postcode(s) [1] 7229 0
3175 - Dandenong
Recruitment postcode(s) [2] 8044 0
3000 - Melbourne
Recruitment postcode(s) [3] 8045 0
2600 - Canberra

Funding & Sponsors
Funding source category [1] 287702 0
Government body
Name [1] 287702 0
Australian Institute of Sport Clinical Research Funding
Country [1] 287702 0
Australia
Funding source category [2] 287703 0
Other Collaborative groups
Name [2] 287703 0
Wetenschappelijk College Fysiotherapie (WCF) part of the Royal Dutch Society for Physical Therapy (KNGF)
Country [2] 287703 0
Netherlands
Funding source category [3] 287704 0
Charities/Societies/Foundations
Name [3] 287704 0
Foundation "De Drie Lichten"
Country [3] 287704 0
Netherlands
Primary sponsor type
University
Name
Monash University
Address
Monash University Penninsula campus
building B
Macmahons Road Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 286434 0
University
Name [1] 286434 0
University Medical Centre Groningen
Address [1] 286434 0
UMCG hp BB 58 Postbus 30001 9700 RB Groningen
Country [1] 286434 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301032 0
monash University
Ethics committee address [1] 301032 0
Ethics committee country [1] 301032 0
Australia
Date submitted for ethics approval [1] 301032 0
01/07/2014
Approval date [1] 301032 0
01/07/2014
Ethics approval number [1] 301032 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41786 0
Prof Jill Cook
Address 41786 0
Monash University McMahon's Road Frankston Victoria 3199
Country 41786 0
Australia
Phone 41786 0
+61399044034
Fax 41786 0
Email 41786 0
[email protected]
Contact person for public queries
Name 41787 0
Jill Cook
Address 41787 0
Monash University McMahon's Road Frankston Victoria 3199
Country 41787 0
Australia
Phone 41787 0
+61399044034
Fax 41787 0
Email 41787 0
[email protected]
Contact person for scientific queries
Name 41788 0
Jill Cook
Address 41788 0
Monash University McMahon's Road Frankston Victoria 3199
Country 41788 0
Australia
Phone 41788 0
+61399044034
Fax 41788 0
Email 41788 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDo isometric and isotonic exercise programs reduce pain in athletes with patellar tendinopathy in-season? A randomised clinical trial.2016https://dx.doi.org/10.1016/j.jsams.2015.11.006
EmbaseIsometric contractions are more analgesic than isotonic contractions for patellar tendon pain: An in-season randomized clinical trial.2017https://dx.doi.org/10.1097/JSM.0000000000000364
N.B. These documents automatically identified may not have been verified by the study sponsor.