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Trial registered on ANZCTR


Registration number
ACTRN12609000354280
Ethics application status
Approved
Date submitted
7/05/2009
Date registered
25/05/2009
Date last updated
6/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of a specific tennis elbow brace (‘Go-Strap brace’) compared to a standard counterforce brace in participants with tennis elbow
Scientific title
Comparing the effects of a novel elbow brace, standard elbow brace and control intervention on elbow pain and function in patients with lateral epicondylalgia
Secondary ID [1] 283537 0
nil known
Universal Trial Number (UTN)
U1111-1149-9753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lateral epicondylalgia 4699 0
Condition category
Condition code
Musculoskeletal 5013 5013 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two independent variables in the research design; treatment condition and time (pre-, post-application). Treatment condition will have three levels; Go-strap (trademark, Sportstek, Australia) brace, a standard counterforce brace and a control condition. Participants will experience each treatment condition in a random order over three separate sessions. Participants will attend at approximately the same time of day on three occasions, each separated by at least 24 hours in order to control for carry-over effects. Go-strap (trademark) brace: An experienced musculoskeletal physiotherapists will apply the brace to the affected elbow, following the manufacturer's instructions for application, in terms of orientation of the brace relative to the elbow and firmness of fit. The brace will be worn only for the time taken for post-intervention assessment (approximately 30 minutes). Hence, the only activities the participants will be performing whilst wearing the brace are the post-intervention outcome measures.
Intervention code [1] 4460 0
Treatment: Devices
Comparator / control treatment
Standard counterforce brace (United Pacific Ltd, Australia): the same physiotherapist will apply this brace to the affected elbow, following the manufacturer's instructions for application, with respect to the orientation of the brace relative to the elbow and firmness of fit. The brace will be worn only for the time taken for post-intervention assessment (approximately 30 minutes). Hence, the only activities the participants will be performing whilst wearing the brace are the post-intervention outcome measures.
Control (no brace): The participant will be in the treatment room with the physiotherapist for the same length of time as the other two interventions, but no manual contact between the therapist and participant will take place.
Control group
Active

Outcomes
Primary outcome [1] 5853 0
Pain-free grip strength: measured using a Digital Analyser grip dynamometer (MIE Ltd, Leeds UK). Each participant will be positioned in supine lie with the upper limb to be measured in shoulder neutral, elbow extension and forearm pronation. They will be instructed to squeeze the dynamometer until pain is first provoked. The process will be repeated three times with an intervening 30-second rest interval, with the average of three measures calculated. Both affected and unaffected arms will be tested.
Timepoint [1] 5853 0
pre-intervention and immediately post-intervention
Secondary outcome [1] 241879 0
Wrist posture: Wrist joint angle will be measured simultaneously with pain-free grip strength using a MTx 3-dimensional sensor (Xsens, Netherlands) attached via velcro to the dorsal surface of the hand. The MTx sensor is an accurate motion tracking device that simultaneously measures angles in three dimensions (heading, roll and pitch). Therefore, measures of wrist flexion/extension and radial/ulna deviation will be simultaneously recorded and will be plotted against the pain-free grip data. The mean angle of three efforts with intervening 30-second rest intervals will be calculated, and the process repeated for the opposite side.
Timepoint [1] 241879 0
pre-intervention and immediately post-intervention
Secondary outcome [2] 241880 0
Pressure pain threshold: A quantitative measure of pain will be obtained by the use of pressure pain algometry, which has previously demonstrated good inter- and intra-rater correlation and reliability. The most sensitive point will be located over the lateral humeral epicondyle by manual palpation and marked with a permanent marker so that the same point can be used for pre- and post-condition application measures. Pressure pain threshold (kp/cm2) will then be measured with a pressure algometer (load cell, switch, data acquisition card and Labview software 8.6; National Instruments, Texas USA) over the site on the lateral elbow that was most tender to palpation. Pressure pain threshold is defined as the amount of pressure that provokes the first onset of pain and is expressed as a ratio of affected/unaffected arms. Three repeat measures with a 30-second rest period between each measurement will be recorded and averaged. Both affected and unaffected arms will be tested.
Timepoint [2] 241880 0
pre-intervention and immediately post-intervention
Secondary outcome [3] 241881 0
Active joint position error: All testing will be carried out using a MTx 3-dimensional motion tracking sensor (Xsens, Netherlands), a slide sheet and board. For measurement of shoulder internal/external rotation and elbow flexion/extension, the MTx sensor will be placed on the dorsal aspect of the distal forearm using velcro. For wrist flexion/extension, the MTx sensor will be placed on the dorsal aspect of the hand and held in place with velcro. In all tests visual cues will be eliminated by a blindfold. Each participant will be asked to wear a no-sleeves or short-sleeved shirt.

Active elbow joint position error (flexion/extension). Active elbow joint reposition error: Participants will be seated at a table with hips and knees flexed to 90 degrees, with their arm in 90 degrees shoulder elevation and neutral rotation. The upper arm will be stabilised against a fixed block using velcro, while the hand will be supported by a cloth doughnut on a low friction surface. Joint reposition sense will be measured by performing an ipsilateral matching activity at random target angles using active angle reproduction. The target positions will be randomly chosen by the investigator, within the range of 30-100 degrees of elbow flexion, as previous studies have suggested that cues from soft tissue stretch and apposition at the ends of range may influence the accuracy of joint position sense. Once the selected target angle has been reached, it will be held in that position for 5 seconds and the participant will be instructed to memorise the position. The limb will then be passively returned to the original starting position. After a pause of 5 seconds the participant will be asked to actively move the forearm back to the same target angle, and to activate a hand held stop button once they felt they had reached the target angle. The angle will be recorded using a customised Labview program (V8.6, National Instruments, Texas USA), this process will then be repeated ten times for each side. The absolute difference between the two measures will be recorded and the mean of ten repetitions will be calculated.

Active shoulder joint position error (rotation). The same procedure described above, will be used to measure joint position error in shoulder rotation. The patient will be seated with the upper arm resting by the participant's side and the forearm and elbow resting on a low-friction slide sheet and board. The humerus will be held against the participant's body by a velcro strap while the hand will be supported by a cloth doughnut on the low friction surface. Using the same protocol described above, the target positions will be randomly chosen by the investigator, within mid-range of internal/external rotation. Ten trials will be recorded and the mean absolute error will be calculated.

Active wrist joint position error (flexion/extension). The participant will be seated with the upper arm resting by the participant's side and the forearm and elbow resting on a low-friction slide sheet and board. The forearm will be held against a fixed block by a velcro strap while the hand will be supported by a cloth doughnut on the low friction surface. Using the same protocol described above, the target positions will be randomly chosen by the investigator, within mid-range of wrist flexion/extension. Ten trials will be recorded and the mean absolute error will be calculated.
Both affected and unaffected arms will be tested for all measures of joint position error.
Timepoint [3] 241881 0
pre-intervention and immediately post-intervention

Eligibility
Key inclusion criteria
Pain over the lateral elbow of a minimum six weeks duration which is increased on palpation of the lateral epicondyle, gripping, and resisted wrist or 2nd or 3rd finger extension.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any treatment of the elbow pain by a health care practitioner within the preceding three months, corticosteroid injection to the affected elbow within the last six months, bilateral elbow symptoms, cervical radiculopathy, any other elbow joint pathology or peripheral nerve involvement, previous surgery to the elbow or a past history of dislocation, fracture of the elbow or tendon ruptures, systemic or neurological disorders, and shoulder, wrist and/or hand pathology.

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)
A research investigator will screen potential participants for eligibility, based on the inclusion/exclusion criteria, via an initial interview. Once informed consent is obtained, participants will receive all three intervention conditions in a random order. A computer-generated randomisation schedule will be drawn up with the order of intervention randomised and administered via concealed allocation (sealed opaque envelopes). This process will be carried out by a research investigator who is independent of the outcome assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
A repeated-measures, crossover, placebo controlled, randomised design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2009
Actual
10/06/2009
Date of last participant enrolment
Anticipated
Actual
28/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4910 0
Commercial sector/Industry
Name [1] 4910 0
United Pacific Industries
Country [1] 4910 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Physiotherapy and Exercise Science
Griffith University
Gold Coast Campus
Qld 4222
Country
Australia
Secondary sponsor category [1] 4439 0
Individual
Name [1] 4439 0
Dr Leanne Bisset
Address [1] 4439 0
School of Physiotherapy and Exercise Science
Griffith University
Gold Coast Campus
Qld 4222
Country [1] 4439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6973 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 6973 0
Ethics committee country [1] 6973 0
Australia
Date submitted for ethics approval [1] 6973 0
Approval date [1] 6973 0
17/03/2009
Ethics approval number [1] 6973 0
PES/26/08/HREC

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

Contacts
Principal investigator
Name 29551 0
Dr Leanne Bisset
Address 29551 0
School of Rehabilitation Sciences
Griffith University
Gold Coast Campus
Qld 4222
Country 29551 0
Australia
Phone 29551 0
+61 7 55527717
Fax 29551 0
Email 29551 0
l.bisset@griffith.edu.au
Contact person for public queries
Name 12798 0
Dr Leanne Bisset
Address 12798 0
School of Physiotherapy & Exercise Science,
Griffith University,
Gold Coast Campus. Qld 4222
Country 12798 0
Australia
Phone 12798 0
+61 7 55527717
Fax 12798 0
+61 7 55528674
Email 12798 0
l.bisset@griffith.edu.au
Contact person for scientific queries
Name 3726 0
Dr Leanne Bisset
Address 3726 0
School of Physiotherapy & Exercise Science,
Griffith University,
Gold Coast Campus. Qld 4222
Country 3726 0
Australia
Phone 3726 0
+61 7 55527717
Fax 3726 0
+61 7 55528674
Email 3726 0
l.bisset@griffith.edu.au

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
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