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


Trial ID
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] 283277 0
'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 290153 0
Condition category
Condition code
Musculoskeletal 290544 290544 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 290680 290680 0 0
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] 288000 0
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] 290570 0
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] 290570 0
Baseline, on completion (week 3) and at 3 week follow-up.
Secondary outcome [1] 304809 0
Objective outcome measures
Pain Free Grip Strength (PFGS) test; metric measurement
Timepoint [1] 304809 0
Baseline, on completion (week 3) and at 3 week follow-up (week 6).
Secondary outcome [2] 305061 0
Objective outcome measures
Muscle Tension Test (MTT); metric measurement
Timepoint [2] 305061 0
Baseline, on completion (week 3) and at 3 week follow-up (week 6)
Secondary outcome [3] 305062 0
Subjective outcome measures
Pain questionnaire; Visual Analogue Scale (VAS)
Timepoint [3] 305062 0
Baseline, on completion (week 3) and at 3 week follow-up (week 6)
Secondary outcome [4] 305063 0
Subjective outcome measures
MASS Deqi questionnaire; 17 item questionnaire using Likert scales.
Timepoint [4] 305063 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
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] 7374 0
2007 - Broadway
Recruitment outside Australia
Country [1] 5534 0
China
State/province [1] 5534 0
Jilin
Country [2] 5535 0
Hong Kong
State/province [2] 5535 0
SAR
Country [3] 5536 0
Italy
State/province [3] 5536 0

Funding & Sponsors
Funding source category [1] 288022 0
Government body
Name [1] 288022 0
National Institute of Complementary Medicine (NICM)
Address [1] 288022 0
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] 288022 0
Australia
Funding source category [2] 288023 0
University
Name [2] 288023 0
University of Technology, Sydney
Address [2] 288023 0
PO Box 123
Broadway NSW 2007
Country [2] 288023 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
PO Box 123
Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 286739 0
None
Name [1] 286739 0
Address [1] 286739 0
Country [1] 286739 0
Other collaborator category [1] 277631 0
Other Collaborative groups
Name [1] 277631 0
World Federation of Acupuncture/Moxibustion Societies (WFAS)
Address [1] 277631 0
B-701, Dongjiu Building, Xizhaosi Street,
Dongcheng Distric, Beijing, China 100061
Country [1] 277631 0
China
Other collaborator category [2] 277632 0
University
Name [2] 277632 0
Changchun University of Chinese Medicine
Address [2] 277632 0
No. 1035, Boshuo Road,
Jingyue Econmic Development
District, Changchun, Jilin province.
Postcode: 130117
Country [2] 277632 0
China
Other collaborator category [3] 277633 0
University
Name [3] 277633 0
School of Chinese Medicine,
Hong Kong Baptist University
Address [3] 277633 0
Jockey Club School of Chinese Medicine Building
7 Baptist University Road,
Kowloon Tong, Kowloon 852
Country [3] 277633 0
Hong Kong
Other collaborator category [4] 277634 0
University
Name [4] 277634 0
Paracelso Institute, Italian Center on Non Conventional Medicine
Address [4] 277634 0
Via Ippolito Nievo,
61 - 00153 Roma
Country [4] 277634 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289945 0
University of Technology, Sydney, Human Research Ethics Committee (UTS HREC)
Ethics committee address [1] 289945 0
PO Box 123,
Broadway NSW 2007
Ethics committee country [1] 289945 0
Australia
Date submitted for ethics approval [1] 289945 0
21/08/2013
Approval date [1] 289945 0
23/09/2013
Ethics approval number [1] 289945 0
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 43186 0
A/Prof Christopher J Zaslawski
Address 43186 0
University of Technology, Sydney,
College of TCM
Department of Medical and Molecular Bioscience
Faculty of Science
PO Box 123
Broadway NSW 2007
Country 43186 0
Australia
Phone 43186 0
+61 2 9514 7856
Fax 43186 0
Email 43186 0
Chris.Zaslawski@uts.edu.au
Contact person for public queries
Name 43187 0
Ms Christine A Berle
Address 43187 0
University of Technology, Sydney,
College of TCM
Department of Medical and Molecular Bioscience
Faculty of Science
PO Box 123
Broadway NSW 2007
Country 43187 0
Australia
Phone 43187 0
+61 2 9632 8989
Fax 43187 0
Email 43187 0
Christine.Berle@uts.edu.au
Contact person for scientific queries
Name 43188 0
A/Prof Christopher J Zaslawski
Address 43188 0
University of Technology, Sydney,
College of TCM
Department of Medical and Molecular Bioscience
Faculty of Science
PO Box 123
Broadway NSW 2007
Country 43188 0
Australia
Phone 43188 0
+61 2 9514 7856
Fax 43188 0
Email 43188 0
Chris.Zaslawski@uts.edu.au