Trial registered on ANZCTR


Trial ID
ACTRN12613000616774
Ethics application status
Approved
Date submitted
15/05/2013
Date registered
29/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised trial of treatment for tennis elbow comparing the effects of different injection treatments on pain reduction
Scientific title
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
Secondary ID [1] 281833 0
None
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
lateral epicondylitis 288189 0
Condition category
Condition code
Musculoskeletal 288553 288553 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description 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

Intervention code [1] 286391 0
Treatment: Drugs
Intervention code [2] 287254 0
Treatment: Other
Comparator / control treatment
1) single ultrasound guided injection of saline (2ml) into the site of maximal abnormality in the elbow
Control group
Placebo

Outcomes
Primary outcome [1] 288713 0
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)
Timepoint [1] 288713 0
Baseline, 3, 6, 12, 24, 52 weeks
Primary outcome [2] 288714 0
Patient-rated Tennis Elbow Evaluation (PRTEE) questionnaire
Timepoint [2] 288714 0
Baseline, 3, 6, 12, 24 and 52 weeks
Secondary outcome [1] 300803 0
Assessment of Quality of Life (AQoL) questionnaire
Timepoint [1] 300803 0
Baseline, 3, 6, 12, 24 and 52 weeks
Secondary outcome [2] 300804 0
Pain-free grip force will be measured with a digital grip dynamometer.
Timepoint [2] 300804 0
Baseline, 12 and 52 weeks
Secondary outcome [3] 300805 0
Direct and indirect health care costs will be calculated using a modified "cost and consequences questionnaire" specifically targeted towards elbow pain.
Timepoint [3] 300805 0
Weekly intervals for the first 12 weeks and every 4 weeks thereafter for a total of 52 weeks
Secondary outcome [4] 300806 0
Perceived recovery: Participants will rate their perceived recovery on a 5- point ordinal scale (‘much worse’ to ‘much improved and/or completely recovered’).
Timepoint [4] 300806 0
3, 6, 12, 24 and 52 weeks
Secondary outcome [5] 300807 0
Adverse effects (such as worsening of pain or discomfort at injection site) will be reported by an open-ended question
Timepoint [5] 300807 0
3, 6, 12, 24 and 52 weeks
Secondary outcome [6] 302799 0
Success of blinding: Participants will be asked to indicate which treatment they believe they received
Timepoint [6] 302799 0
12 and 52 weeks
Secondary outcome [7] 302800 0
Use of online vs. paper questionnaire completion
Timepoint [7] 302800 0
52 weeks
Secondary outcome [8] 320130 0
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). This is a composite secondary outcome
Timepoint [8] 320130 0
measured weekly for first 12 weeks, then every 4 weeks up to 52 weeks

Eligibility
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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Participants will be recruited via online and printed advertisements 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.
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 administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/06/2013
Actual date of first participant enrolment
5/06/2013
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
180
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 5117 0
The Queen Elizabeth Hospital - Woodville

Funding & Sponsors
Funding source category [1] 286617 0
Government body
Name [1] 286617 0
National Health and Medical Research Council
Address [1] 286617 0
National Health and Medical Research Council
GPO Box 1421
Canberra City ACT 2601
Country [1] 286617 0
Australia
Primary sponsor type
Individual
Name
Professor Rachelle Buchbinder
Address
Suite 41, Cabrini Medical Centre
183 Wattletree Rd,
Malvern, VIC 3144
Country
Australia
Secondary sponsor category [1] 285403 0
None
Name [1] 285403 0
Address [1] 285403 0
Country [1] 285403 0
Other collaborator category [1] 277264 0
Individual
Name [1] 277264 0
Professor Anthony Harris
Address [1] 277264 0
Monash University Centre for Health Economics
Clayton Campus, Wellington Rd
Victoria 3800
Country [1] 277264 0
Australia
Other collaborator category [2] 277294 0
Individual
Name [2] 277294 0
Dr Margaret Staples
Address [2] 277294 0
Monash Department of Clinical Epidemiology, Cabrini Hospital
Cabrini Medical Centre
183 Wattletree Rd
Malvern
Victoria, 3144
Country [2] 277294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288690 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 288690 0
Cabrini Hospital
181-183 Wattletree Road
Malvern VIC 3144
Ethics committee country [1] 288690 0
Australia
Date submitted for ethics approval [1] 288690 0
Approval date [1] 288690 0
25/02/2013
Ethics approval number [1] 288690 0
05-04-02-13
Ethics committee name [2] 289268 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 289268 0
Monash University
Building 3E, Room 111
Clayton Campus
Wellington Rd
Clayton, VIC 3800
Ethics committee country [2] 289268 0
Australia
Date submitted for ethics approval [2] 289268 0
Approval date [2] 289268 0
19/03/2013
Ethics approval number [2] 289268 0
CF13/765-2013000342
Ethics committee name [3] 294233 0
Sydney Local Health District (RPAH Zone)
Ethics committee address [3] 294233 0
Research development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [3] 294233 0
Australia
Date submitted for ethics approval [3] 294233 0
11/11/2013
Approval date [3] 294233 0
17/02/2014
Ethics approval number [3] 294233 0
Protocol No X13-0401 & HREC/13/RPAH/556
Ethics committee name [4] 294234 0
CALHN Research Office
Ethics committee address [4] 294234 0
Level 4, Women's Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [4] 294234 0
Australia
Date submitted for ethics approval [4] 294234 0
19/03/2015
Approval date [4] 294234 0
26/11/2015
Ethics approval number [4] 294234 0
SSA/15/TQEH/165

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37318 0
Prof Rachelle Buchbinder
Address 37318 0
Suite 41, Cabrini Medical Centre
183 Wattletree Rd, Malvern, VIC 3144
Country 37318 0
Australia
Phone 37318 0
(613) 9508 1652
Fax 37318 0
Email 37318 0
rachelle.buchbinder@monash.edu
Contact person for public queries
Name 37319 0
Dr Allison Macpherson
Address 37319 0
Suite 41, Cabrini Medical Centre
183 Wattletree Rd, Malvern, VIC 3144
Country 37319 0
Australia
Phone 37319 0
(613) 9508 1452
Fax 37319 0
Email 37319 0
ABourne@cabrini.com.au
Contact person for scientific queries
Name 37320 0
Prof Rachelle Buchbinder
Address 37320 0
Suite 41, Cabrini Medical Centre
183 Wattletree Rd, Malvern, VIC 3144
Country 37320 0
Australia
Phone 37320 0
(613) 9508 1652
Fax 37320 0
Email 37320 0
rachelle.buchbinder@monash.edu