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Trial registered on ANZCTR


Registration number
ACTRN12614000398606
Ethics application status
Approved
Date submitted
8/04/2014
Date registered
11/04/2014
Date last updated
11/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Corticosteroid, Autologous blood or Polidocanol injections guided by ultrasound in the management of tennis elbow: a randomised clinical pilot trial. (The CAP trial)
Scientific title
Corticosteroid, Autologous blood or Polidocanol injections guided by ultrasound in the management of tennis elbow: a randomised clinical pilot trial. (The CAP trial)
Secondary ID [1] 284188 0
nil known
Universal Trial Number (UTN)
Trial acronym
The CAP trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tennis Elbow (lateral epicondylalgia) 291284 0
Condition category
Condition code
Musculoskeletal 291638 291638 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291991 291991 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound Guided Injection techniques:

Corticosteroid injection
The Common extensor tendon is assessed with ultrasound for tear and tendinopathy and if required the skin is marked with a texta over the abnormal area. The skin is prepared with a chlorhexidine wash. With Ultrasound guidance, using a 25 g needle the CEO tendon substance and superficial surface is infiltrated with 3ml of 0.5% Xylocaine.
With a second 25 g needle and syringe, 1 ml Celestone chronodose and 1ml of Marcaine is inject with ultrasound guidance into the abnormal tendon substance and also along the superficial tendon surface.


Autologous Blood Injection (ABI)
The Common extensor tendon was assessed with ultrasound for tear and tendinopathy and if required the skin was marked with a texta over the abnormal area.
The skin is prepared with a chlorhexidine wash.
Using Ultrasound guidance a 25 g needle is inserted and 3ml of 0.5% Xylocaine is injected into the abnormal area and superficial to the tendon. Multiple dry needling punctures of the tendon are performed at this time to cause local bleeding.
3 ml of autologous blood is drawn from a cubital fossa vein of the other elbow.
This blood is mixed with 1ml of Marcaine and injected into the tendon with ultrasound guidance via a second 25 g needle and syringe targeting the abnormal area.

Sclerosant Injection
The Common extensor tendon is assessed with ultrasound for tear and tendinopathy.
The distribution of neovascularity is assessed. The neovascularity arises medial to the CEO from the radial collateral branch of the profunda artery and radial recurrent artery. The neovascularity then courses from medial to lateral superficial to the CEO. The sites of neovascularity are marked on the skin with a texta.
The skin is prepared with a chlorhexidine wash.

With ultrasound guidance between 2-4ml of Polidocanol is injected via a 25 g needle into the neovascularity superficial to the tendon. The neovacularity is targeted from lateral to medial back to the normal artery.
Care is taken to inject the only the neovascularity outside the tendon. Polidocanol is not injected into the tendon substance and also is not injected too superficially to avoid causing skin necrosis.

In the sclerosant and ABI groups, injections are repeated at four weeks.

Physiotherapy Protocol: All participants will be given an information sheet outlining activity modification and taught a home eccentric exercise program.
Intervention code [1] 288883 0
Treatment: Other
Intervention code [2] 288912 0
Treatment: Drugs
Intervention code [3] 288940 0
Rehabilitation
Comparator / control treatment
This trial is comparing the 3 ultrasound guided injections, Corticosteroid, Autologous blood and Polidocanol (sclerosant) injections. As Corticosteroid has been in use for longer and has most high quality research, it could be viewed as the comparator treatment (but not as a control).
Control group
Active

Outcomes
Primary outcome [1] 291569 0
Global Rating of Change scale (GROC)
Timepoint [1] 291569 0
4, 12, 26 weeks
Secondary outcome [1] 307103 0
Patient rated elbow evaluation questionnaire (PREE) will be used as a self rated measure of elbow pain (5 questions, range 0-50) and elbow function (11 questions, range 0-110).
Timepoint [1] 307103 0
Baseline, 4, 12, 26 weeks
Secondary outcome [2] 307230 0
The Stratford Pain-free function Questionnaire will be used as a self-rated measure of elbow discomfort (8 Questions, range 0-8).
Timepoint [2] 307230 0
Baseline, 4, 12, 26 weeks
Secondary outcome [3] 307231 0
Ultrasound measures: Greyscale ultrasound (echogenicity), tendon thickness, and power doppler (neovascularity).
Timepoint [3] 307231 0
Baseline, 4, 12, 26 weeks
Secondary outcome [4] 307723 0
Pain free grip force will be measured with a hand-held dynamometer in triplicate, with mean scores used in analysis. The participant will grip the dynamometer stopping at the first moment elbow pain is experienced. It will be measured over the affected and unaffected arms and ratio of affected to unaffected arm will be computed.
Timepoint [4] 307723 0
Baseline, 4, 12, 26 weeks

Eligibility
Key inclusion criteria
Inclusion criteria is the presence of lateral elbow pain, which was exacerbated by activities involving wrist extension and gripping, as reported by the patient, as well as a clinical diagnosis of tennis elbow, which included elbow pain on resisted wrist and/or middle finger extension and tenderness in the area of the lateral epicondyle for more than two months.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria is elbow pain for less than two months, limitation of movement with passive forearm pronation, supination, flexion and/or extension that may indicate radioulnar joint synovitis or osteoarthritis, upper limb neurological symptoms or signs that may indicate cervical radiculopathy, and corticosteroid injection, autologous blood or scleosant injection to the common extensor tendon within the previous three months.

Patients meeting the inclusion and exclusion criteria above, will be referred for power Doppler ultrasound investigation.
Participants without evidence of neovascularisation on power ultrasound will be excluded from further participation in the study.

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)
Patients will be recruited from the greater Melbourne region of Australia, with a provisional diagnosis of unilateral tennis elbow. Patients can be referred to the study from General Practitioners, physios and other sports physicians.
They may also be self-referred after reading advertising in the local paper regarding the study.
Patients will be phone screened and screened by the study sports physician registrars before final entry. Participants with neovascularisation will be randomised via concealed allocation into one of three groups to receive either ultrasound guided corticosteroid, autologous blood or sclerosant injection. A trial nurse who is not deciding eligibility will be responsible for allocation as below.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated through drawing of lots from a box (blinded) in order of presentation by the trial nurse.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Categorical outcomes will be compared between treatments using Chi-squared analysis. Continuous outcomes will be examined using analysis of variance including time and treatment factors. Post hoc testing with Bonferroni correction will be used for multiple comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2012
Actual
2/01/2012
Date of last participant enrolment
Anticipated
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288818 0
Self funded/Unfunded
Name [1] 288818 0
Country [1] 288818 0
Primary sponsor type
University
Name
University of Queensland
Address
C/-Bill Vicenzino
University of Queensland
Therapies building 84
St Lucia 4072
Country
Australia
Secondary sponsor category [1] 287514 0
None
Name [1] 287514 0
Address [1] 287514 0
Country [1] 287514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290787 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 290787 0
Ethics committee country [1] 290787 0
Date submitted for ethics approval [1] 290787 0
Approval date [1] 290787 0
14/05/2010
Ethics approval number [1] 290787 0
H355

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

Contacts
Principal investigator
Name 46646 0
Dr Cornelius du Toit
Address 46646 0
Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
VIC
3001
Country 46646 0
Australia
Phone 46646 0
+613 9420 4300
Fax 46646 0
Email 46646 0
neelsils@bigpond.com
Contact person for public queries
Name 46647 0
Bill Vicenzino
Address 46647 0
Room 822, Level 8
Therapies Building 84a
CCRE Spine
School of Health and Rehab Sciences
The University of Queensland
Brisbane Qld 4072
Country 46647 0
Australia
Phone 46647 0
+61733652781
Fax 46647 0
Email 46647 0
b.vicenzino@uq.edu.au
Contact person for scientific queries
Name 46648 0
Cornelius du Toit
Address 46648 0
Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
VIC
3001
Country 46648 0
Australia
Phone 46648 0
+613 9420 4300
Fax 46648 0
Email 46648 0
neelsils@bigpond.com

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
EmbaseComparison of corticosteroid, autologous blood or sclerosant injections for chronic tennis elbow.2017https://dx.doi.org/10.1016/j.jsams.2016.10.010
N.B. These documents automatically identified may not have been verified by the study sponsor.