ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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)

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

Treatment: Drugs

Intervention code [3]

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]

Global Rating of Change scale (GROC)

Timepoint [1]

4, 12, 26 weeks

Secondary outcome [1]

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]

Baseline, 4, 12, 26 weeks

Secondary outcome [2]

The Stratford Pain-free function Questionnaire will be used as a self-rated measure of elbow discomfort (8 Questions, range 0-8).

Timepoint [2]

Baseline, 4, 12, 26 weeks

Secondary outcome [3]

Ultrasound measures: Greyscale ultrasound (echogenicity), tendon thickness, and power doppler (neovascularity).

Timepoint [3]

Baseline, 4, 12, 26 weeks

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

14/05/2010

Ethics approval number [1]

H355

Summary

Brief summary

This study aims to compare the efficacy of corticosteroid vs. autologous blood vs. sclerosant injection for the treatment of tennis elbow in order to see which treatment modality incurs the most benefit.

Trial website

Trial related presentations / publications

There have been no public presentations or publications

Public notes

Contacts

Principal investigator

Name

Dr Cornelius du Toit

Address

Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
VIC
3001

Country

Australia

Phone

+613 9420 4300

Fax

[email protected]

Contact person for public queries

Name

Bill Vicenzino

Address

Room 822, Level 8
Therapies Building 84a
CCRE Spine
School of Health and Rehab Sciences
The University of Queensland
Brisbane Qld 4072

Country

Australia

Phone

+61733652781

Fax

[email protected]

Contact person for scientific queries

Name

Cornelius du Toit

Address

Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
VIC
3001

Country

Australia

Phone

+613 9420 4300

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Comparison of corticosteroid, autologous blood or sclerosant injections for chronic tennis elbow.	2017	https://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.

Trial Review

Documents added manually

Documents added automatically