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Trial registered on ANZCTR

Registration number

ACTRN12613001138774

Ethics application status

Approved

Date submitted

27/09/2013

Date registered

11/10/2013

Date last updated

24/10/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Tennis Elbow Acupuncture International Study - China, Hong Kong, Australia and Italy

Scientific title

A multi-centre, double blind (outcome assessor and participant), randomised, controlled trial comparing the efficacy of manual acupuncture to inactive control sham laser for the treatment of chronic (greater than 3 months) lateral elbow pain.

Secondary ID [1]

'Nil'

Universal Trial Number (UTN)

U1111-1148-1401

Trial acronym

TEA IS CHAI (Tennis Elbow Acupuncture International Study - China, Hong Kong, Australia and Italy)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tendinosis of the common extensor carpi radialis brevis tendon commonly called tennis elbow or lateral epicondylitis

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There are two arms to the trial; interventions include a treatment group which will receive traditional acupuncture and a control group which will receive inactive laser therapy to the same local acupoints as the treatment group using a modified inactive sham laser unit. Nine treatments will be administered over a three week period (three treatments per week). Each intervention session will take approximately 30-40 minutes.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control group will receive inactive laser therapy to the same local acupoints as the treatment group using a modified inactive sham laser unit.

Control group

Placebo

Outcomes

Primary outcome [1]

Subjective outcome measure; Disabilities of Arm Shoulder and Hand (DASH) questionnaire which is a 30 item questionnaire rated with descriptors between 1 (no difficulty) - 5 (unable) plus two extra modules (work and sport).

Timepoint [1]

Baseline, on completion (week 3) and at 3 week follow-up.

Secondary outcome [1]

Objective outcome measures
Pain Free Grip Strength (PFGS) test; metric measurement

Timepoint [1]

Baseline, on completion (week 3) and at 3 week follow-up (week 6).

Secondary outcome [2]

Objective outcome measures
Muscle Tension Test (MTT); metric measurement

Timepoint [2]

Baseline, on completion (week 3) and at 3 week follow-up (week 6)

Secondary outcome [3]

Subjective outcome measures
Pain questionnaire; Visual Analogue Scale (VAS)

Timepoint [3]

Baseline, on completion (week 3) and at 3 week follow-up (week 6)

Secondary outcome [4]

Subjective outcome measures
MASS Deqi questionnaire; 17 item questionnaire using Likert scales.

Timepoint [4]

Baseline, on completion (week 3) and at 3 week follow-up (week 6)

Eligibility

Key inclusion criteria

Chronic lateral elbow pain (duration greater than 3 months)

Unilateral localisation

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Diseases of the central or peripheral nervous system
2. Inflammatory rheumatic diseases
3. Gout
4. Earlier episodes of lateral elbow pain treated surgically
or with;
- acupuncture treatment or physiotherapy for tennis
elbow within the previous 3 months
- acupuncture treatment for any problems within the
previous week
- concurrent physiotherapy for tennis elbow.

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)

1. Interview with explanation of intervention, tests and
questionnaires
2. Physical examination of the forearm/elbow
3. If applicant remains enthusiastic to participate in the
study, written consent is sought
Randomisation; The blinded outcome assessor will send an email with the participant's two digit identification trial number to a designated person (third party, who is responsible for participant randomisation and located off site). This person is blinded to the participant/s. A three digit code number will then be inserted into the identification trial number by the third party and emailed or telephoned to the practitioner administering the allocated intervention. Only the third party and the practitioner administering the intervention will be able to identify the coded three digit number.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The email from the blinded outcome assessor will contain; the unique identification trial number of the participant (minus the unique three numbers that are required for group allocation), the sex and the participant's general DASH score (not including work and sport module). The third party will use a computer generated package (MINIM) (designed by Stephen Evans, Simon Day and Patrick Royston) to generate a 1:1 allocation.

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

Due to the nature of the interventions neither participants nor study personnel can be blinded to allocation (acupuncture or laser), however the participant, outcome assessor and statistician will be blinded to the study hypothesis in terms that the laser machine has been deactivated and therefore a non-active control therapy. A credibility scale questionnaire will be used to identify the credibility and adequacy of the control. Efficacy of successful blinding will also be tested following the last intervention using a treatment satisfaction questionnaire where participants will be asked to tick a box as to whether they believe they received a valuable therapeutic treatment (yes, no, do not know) and "What are your reasons for believing this?".

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical methods for analysing primary (DASH), and secondary outcomes (Pain Free Grip Strength [PFGS], Muscle Tension Test [MTT] and VAS Pain Questionnaire) will be analysed using Analysis of variance. The secondary outcome, MASS Deqi Questionnaire will be analysed using Student t-test and participant demographics will be analysised using descriptive statistics and chi square tests.

The estimated sample size for this study has been calculated using the primary outcome measure DASH data collected from a pilot study data undertaken in ChangChun, China.

The standard deviation of the DASH score for the treatment group was 7.50 points at baseline and 4.89 points at 2 weeks follow up. The mean DASH score for the treatment group was 27.14 at baseline and 8.56 points at 2 weeks follow up.

The standard deviation of the DASH score for the control group was 11.27 at baseline and 7.35 at 2 weeks follow up. The mean DASH score for the control group was 21.86 at baseline and 15.95 at 2 weeks follow up.

Using the highest standard deviation (11.27 points) as a conservative measure, to detect a 13 DASH points difference between the treatment and control groups, at a 5% significance level, a sample size of 55 subjects would lead to a power of 0.99. Taking a 20% drop out rate into account, a total of 69 subjects will be required for the whole study. It was then agreed that each country would recruit 24 subjects each, giving a total of 96.

In order to preserve the benefit of randomisation as a mechanism to avoid selection bias, all out-come data obtained from all participants will be included in the data analysis by the group each participant was randomised. This will be done regardless of each participant’s adherence to protocol and/or their retention in the study. These two conditions define an “intention to treat” analysis.

Although strategies have been developed to maximise participant follow-up and prevent missing data, reasons for withdrawal and incidence of missing data will be recorded for qualitative comparison between randomised groups.

Imputation of missing data will allow the analysis to conform to intention to treat analysis. The method of single imputation will be used to carry the last of the participant’s recorded observations forward or in the absence of collected data the baseline observation will be carried forward.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

21/10/2013

Actual

Date of last participant enrolment

Anticipated

31/03/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2007 - Broadway

Recruitment outside Australia

Country [1]

China

State/province [1]

Jilin

Country [2]

Hong Kong

State/province [2]

SAR

Country [3]

Italy

State/province [3]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Institute of Complementary Medicine (NICM)

Address [1]

Office Manager
National Institute of Complementary Medicine (NICM)
UWS - Upper Level Bldg 3 Campbelltown Campus

Postal address
Locked Bag 1797
South Penrith DC 1797

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Technology, Sydney

Address [2]

PO Box 123
Broadway NSW 2007

Country [2]

Australia

Primary sponsor type

University

Name

University of Technology, Sydney

Address

PO Box 123
Broadway NSW 2007

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

World Federation of Acupuncture/Moxibustion Societies (WFAS)

Address [1]

B-701, Dongjiu Building, Xizhaosi Street,
Dongcheng Distric, Beijing, China 100061

Country [1]

China

Other collaborator category [2]

University

Name [2]

Changchun University of Chinese Medicine

Address [2]

No. 1035, Boshuo Road,
Jingyue Econmic Development
District, Changchun, Jilin province.
Postcode: 130117

Country [2]

China

Other collaborator category [3]

University

Name [3]

School of Chinese Medicine,
Hong Kong Baptist University

Address [3]

Jockey Club School of Chinese Medicine Building
7 Baptist University Road,
Kowloon Tong, Kowloon 852

Country [3]

Hong Kong

Other collaborator category [4]

University

Name [4]

Paracelso Institute, Italian Center on Non Conventional Medicine

Address [4]

Via Ippolito Nievo,
61 - 00153 Roma

Country [4]

Italy

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Technology, Sydney, Human Research Ethics Committee (UTS HREC)

Ethics committee address [1]

PO Box 123,
Broadway  NSW 2007

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/08/2013

Approval date [1]

23/09/2013

Ethics approval number [1]

2013000614

Summary

Brief summary

This research is to find out whether there are any health benefits using acupuncture for people with lateral elbow pain.

Lateral elbow pain is one of the most common musculoskeletal pains of the arm with estimated population incidence of 1-3% (Fink et al 2002).  Ninety percent of patients can initially be cured with conservative treatment and rest; however the complaint frequently recurs after resumption of work or sport (Fink et al 2002).  Optimum treatment in primary care is still unclear (Webster-Harrison et al 2009).  In the past 10 years acupuncture has become increasingly recognised as an alternative treatment for pain, including lateral elbow pain (Trinh et al 2004).  In a publication by the United States National Institutes of Health it was determined that acupuncture may be useful as an adjunct treatment or an acceptable alternative treatment for tennis elbow (lateral epicondylitis) (NIH Consensus Development Panel on Acupuncture 1998).

Based on the largely positive results obtained from a pilot study, negotiations over the last twelve months have resulted in our international colleagues enthusiastic to advance this project to an international study.

The aim/hypothesis of the study is; does acupuncture treatment compared to sham laser improve physical functioning and a reduction in symptoms for people with chronic tennis elbow pain?

References:
Fink, M, Wolkenstein, E, Karst, M and Gehrke, A 2002, 'Acupuncture in chronic epicondylitis: a randomized controlled trial', Rheumatology, vol. 41, pp. 205-209.

NIH 1998, 'NIH consensus conference: acupuncture', vol. 280(17), JAMA, pp. 1518-1524.

Trinh, K V, Phillips, S D, Ho, E and Damsma, K 2004, 'Acupuncture for the alleviation of lateral epicondyle pain: s systematic review', Rheumatology, vol. 43, pp. 1085-1090.

Webster-Harrison, P, White, A and Rae, J 2009, 'Acupuncture for tennis elbow: An e-mail consensus study to define a standardised treatment in a GPs' surgery', Acupuncture in Medicine, vol. 20, no. 4, pp. 181-185.

Trial website

Trial related presentations / publications

Public notes

This project is a collaborative multi-site clinical trial research project being conducted between China, Hong Kong, Australia and Italy under the auspices of the World Federation of Acupuncture/Moxibustion Societies (WFAS) with each site funding its own costs, applying for their own HREC approval and registering the trial in their country independently.

Contacts

Principal investigator

Name

A/Prof Christopher J Zaslawski

Address

University of Technology, Sydney,
College of TCM
Department of Medical and Molecular Bioscience
Faculty of Science
PO Box 123
Broadway NSW 2007

Country

Australia

Phone

+61 2 9514 7856

Fax

Chris.Zaslawski@uts.edu.au

Contact person for public queries

Name

Christine A Berle

Address

University of Technology, Sydney,
College of TCM
Department of Medical and Molecular Bioscience
Faculty of Science
PO Box 123
Broadway NSW 2007

Country

Australia

Phone

+61 2 9632 8989

Fax

Christine.Berle@uts.edu.au

Contact person for scientific queries

Name

Christopher J Zaslawski

Address

University of Technology, Sydney,
College of TCM
Department of Medical and Molecular Bioscience
Faculty of Science
PO Box 123
Broadway NSW 2007

Country

Australia

Phone

+61 2 9514 7856

Fax

Chris.Zaslawski@uts.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

Source	Title	Year of Publication	DOI
Embase	Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy.	2016	https://dx.doi.org/10.1155/2016/1868659
Embase	Investigation of the Phenomenon of Propagated Sensation along the Channels in the Upper Limb Following Administration of Acupuncture and Mock Laser.	2017	https://dx.doi.org/10.1016/j.jams.2017.06.007
Embase	Psychophysical responses in patients receiving a mock laser within context of an acupuncture clinical trial: An interoceptive perspective.	2017	https://dx.doi.org/10.1186/s12906-017-1859-0
Embase	Anxiety related to De Qi psychophysical responses as measured by MASS: A sub-study embedded in a multisite randomised clinical trial.	2018	https://dx.doi.org/10.1016/j.ctim.2018.05.009
Embase	A multi-center international study of acupuncture for lateral elbow pain - Results of a randomized controlled trial.	2020	https://dx.doi.org/10.1002/ejp.1574

N.B. These documents automatically identified may not have been verified by the study sponsor.

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