Trial from ANZCTR


Trial ID ACTRN12613000616774
Trial Status: Registered
Date Submitted: 15/05/2013
Date Registered: 29/05/2013
Prospectively registered

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Public title Randomised trial of treatment for tennis elbow comparing the effects of different injection treatments on pain reduction
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Comparative effectiveness of ultrasound-guided injection with either autologous platelet rich plasma or glucocorticoid for ultrasound-proven lateral epicondylitis: a three-arm randomised placebo-controlled trial
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Secondary ID [1] 281833 0
None
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
lateral epicondylitis 288189 0
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Condition category: Condition code:
Musculoskeletal Other muscular and skeletal disorders
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288553 288553 0 0

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Descriptions of intervention(s) / exposure 1) single ultrasound guided injection of autologous platelet rich plasma (2ml) into the site of maximal abnormality in the elbow.

To obtain the autologous platelet rich plasma, 5 ml of venesected blood will be centrifuged for 7 minutes at 1500 revs/sec and then the buffy coating and 2ml of the supernatant will be aspirated using a 22 gauge needle into a 3ml syringe. This 2ml will then be injected into the elbow.

2) single ultrasound guided injection of glucocorticoid (Celestone Chronodose 1ml + 1 ml normal saline) into the site of maximal abnormality in the elbow

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Intervention Code:
Treatment: Drugs 286391 0
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Intervention Code:
Treatment: Other 287254 0
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Comparator / control treatment 1) single ultrasound guided injection of saline (2ml) into the site of maximal abnormality in the elbow
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Control group Placebo
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Primary Outcome: Participant's global assessment of overall pain, pain at night and activity-related pain will be measured with a standardized 0-10 numerical scale comprising a vertical scale labelled ’no pain‘ at the bottom (0) and ’maximal imaginable pain‘ at the top (10) 288713 0
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Timepoint: Baseline, 3, 6, 12, 24, 52 weeks 288713 0
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Primary Outcome: Patient-rated Tennis Elbow Evaluation (PRTEE) questionnaire 288714 0
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Timepoint: Baseline, 3, 6, 12, 24 and 52 weeks 288714 0
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Secondary Outcome: Assessment of Quality of Life (AQoL) questionnaire 300803 0
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Timepoint: Baseline, 3, 6, 12, 24 and 52 weeks 300803 0
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Secondary Outcome: Pain-free grip force will be measured with a digital grip dynamometer. 300804 0
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Timepoint: Baseline, 12 and 52 weeks 300804 0
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Secondary Outcome: Direct and indirect health care costs will be calculated using a modified "cost and consequences questionnaire" specifically targeted towards elbow pain. 300805 0
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Timepoint: Weekly intervals for the first 12 weeks and every 4 weeks thereafter for a total of 52 weeks 300805 0
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Secondary Outcome: Perceived recovery: Participants will rate their perceived recovery on a 5- point ordinal scale (‘much worse’ to ‘much improved and/or completely recovered’). 300806 0
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Timepoint: 3, 6, 12, 24 and 52 weeks 300806 0
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Secondary Outcome: Adverse effects (such as worsening of pain or discomfort at injection site) will be reported by an open-ended question 300807 0
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Timepoint: 3, 6, 12, 24 and 52 weeks 300807 0
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Secondary Outcome: Success of blinding: Participants will be asked to indicate which treatment they believe they received 302799 0
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Timepoint: 12 and 52 weeks 302799 0
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Secondary Outcome: Use of online vs. paper questionnaire completion 302800 0
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Timepoint: 52 weeks 302800 0
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Key inclusion criteria 1) lateral elbow pain > or = six weeks duration
2) reproducibility of pain by two or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow, gripping, resisted wrist or second or third finger extension (dorsiflexion)
3) ultrasound-confirmed lesion
4) ability to read and write in English
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Minimum age 18 Years
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Maximum age 65 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria 1) bilateral symptoms of lateral elbow pain
2) any other elbow pathology
3) generalised inflammatory arthritis such as rheumatoid arthritis
4) concurrent shoulder and/or neck pain and/or pain proximal to the elbow on the affected side
5) any wound or skin lesion on the lateral side of the affected elbow
6) neurological symptoms or signs in the affected arm
7) severe infection
8) known malignancy
9) bleeding disorder
10) previous surgery to the elbow
11) local glucocorticoid injection in the previous six months
12) oral glucocorticoids in the previous three months
13) large tear > or = 15mm in the common extensor origin
or a torn lateral collateral ligament
14) lack of informed consent
15) any other reason thought likely to result in inability to complete the trial
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Participants will be recruited via advertisements in local print media and from medical practitioners. Respondents will undergo an initial screening to ensure inclusion. Those who are eligible at this point will be given the participant information and consent form and will be invited to participate provided ultrasound criteria are met. Following written consent and diagnostic ultrasonography, participants will be randomly assigned in random permuted blocks of differing sizes to receive one of the three treatment regimens, stratified by radiologist and size of the tear (< or > or = 6mm). The randomisation sequence will be created using a computer-generated table of random numbers. To conceal randomisation, stratified allocations will be sealed in consecutively numbered opaque envelopes and kept in a locked location accessible only by an independent administrator. This administrator (not involved in the trial in any other capacity except for opening randomisation envelopes and preparing syringes with treatments) will open the next envelope in sequence at each site and prepare syringes accordingly.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer generated randomisation schedule
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply) The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Assignment
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 1/06/2013
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 180
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s) VIC
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Recruitment outside Australia

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Funding Source: Government body 286617 0
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Name: National Health and Medical Research Council 286617 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra City ACT 2601
286617 0
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Country: Australia 286617 0
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Primary Sponsor Individual
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Name: Professor Rachelle Buchbinder
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Address: Suite 41, Cabrini Medical Centre
183 Wattletree Rd,
Malvern, VIC 3144
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Country: Australia
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Secondary Sponsor: None 285403 0
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Name: 285403 0
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Address: 285403 0
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Country: 285403 0
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Other Collaborator: Individual 277264 0
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Name: Professor Anthony Harris 277264 0
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Address: Monash University Centre for Health Economics
Clayton Campus, Wellington Rd
Victoria 3800
277264 0
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Country: Australia 277264 0
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Other Collaborator: Individual 277294 0
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Name: Dr Margaret Staples 277294 0
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Address: Monash Department of Clinical Epidemiology, Cabrini Hospital
Cabrini Medical Centre
183 Wattletree Rd
Malvern
Victoria, 3144
277294 0
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Country: Australia 277294 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Cabrini Human Research Ethics Committee 288690 0
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Address: Cabrini Hospital
181-183 Wattletree Road
Malvern VIC 3144
288690 0
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Country: Australia 288690 0
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Approval Date: 25/02/2013 288690 0
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Submitted Date: 288690 0
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HREC: 05-04-02-13 288690 0
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Ethics Committee name: Monash University Human Research Ethics Committee (MUHREC) 289268 0
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Address: Monash University
Building 3E, Room 111
Clayton Campus
Wellington Rd
Clayton, VIC 3800
289268 0
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Country: Australia 289268 0
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Approval Date: 19/03/2013 289268 0
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Submitted Date: 289268 0
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HREC: CF13/765-2013000342 289268 0
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Brief summary Lateral epicondylitis (LE) or tennis elbow is a debilitating musculoskeletal condition that can result in significant disability, health care utilisation, lost productivity and costs. Glucocorticoid injection is of proven short-term benefit, but beyond 8 weeks its benefits have not been established and some studies have even suggested a rebound worsening of symptoms. Autologous platelet rich plasma (PRP) appears to be a promising new treatment for LE however strong evidence for its efficacy from high quality randomised placebo-controlled trials is currently lacking. The aim of this study is to compare the effectiveness of ultrasound-guided injection with either autologous platelet rich plasma or glucocorticoid using a three-arm randomised placebo-controlled trial design.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Prof
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Name: Rachelle Buchbinder
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Address: Suite 41, Cabrini Medical Centre 183 Wattletree Rd, Malvern, VIC 3144
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Country: Australia
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Tel: (613) 9508 1652
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Email: rachelle.buchbinder@monash.edu
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Contact person for public queries
Title: Dr
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Name: Allison Bourne
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Address: Suite 41, Cabrini Medical Centre 183 Wattletree Rd, Malvern, VIC 3144
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Country: Australia
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Tel: (613) 9508 1452
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Email: ABourne@cabrini.com.au
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Contact person for scientific queries
Title: Prof
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Name: Rachelle Buchbinder
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Address: Suite 41, Cabrini Medical Centre 183 Wattletree Rd, Malvern, VIC 3144
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Country: Australia
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Tel: (613) 9508 1652
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Email: rachelle.buchbinder@monash.edu
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Contact person responsible for updating information
Title: Dr
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Name: Allison Bourne
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Address: Suite 41, Cabrini Medical Centre 183 Wattletree Rd, Malvern, VIC 3144
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Country: Australia
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Tel: (613) 9508 1452
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Email: ABourne@cabrini.com.au
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Addition Cancer fields
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