Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000928213
Ethics application status
Approved
Date submitted
26/10/2009
Date registered
28/10/2009
Date last updated
15/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of acupuncture on lateral elbow pain compared to laser: a randomised controlled pilot study.
Scientific title
The effect of acupuncture compared to sham laser on pressure pain threshold for lateral elbow pain in people aged 33 to 55.
Secondary ID [1] 281036 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic unilateral elbow pain 252056 0
Condition category
Condition code
Alternative and Complementary Medicine 252258 252258 0 0
Other alternative and complementary medicine
Musculoskeletal 252259 252259 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
acupuncture to the acupoints LI 10, LI 11,
TE 5, LI4, ashi pt (all unilateral on side of pain) and GB 34(both sides)
2 x 20 minute sessions per week for 5 weeks (total 10 acupuncture sessions)
Intervention code [1] 241453 0
Treatment: Devices
Comparator / control treatment
inactive laser to the acupoints LI 10, LI 11,
TE 5, LI4, ashi pt (all unilateral on side of pain) and GB 34(both sides)
2 x 20 minute sessions per week for 5 weeks
(total 10 sham, laser sessions)
Control group
Placebo

Outcomes
Primary outcome [1] 253123 0
Pressure pain threshold at two acupoint sites (Large Intestine 10 and Large Intestine 11)
Timepoint [1] 253123 0
One week prior to commencing intervention (week -1)
At intervention commencement (week 0)
At end of intervention phase (week 5)
One month follow up assessment (week9)
Secondary outcome [1] 257999 0
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Timepoint [1] 257999 0
One week prior to commencing intervention (week -1)
At intervention commencement (week 0)
Weekly (weeks 1,2,3,4,5)
One month follow up assessment (week9)
Secondary outcome [2] 258000 0
McGill -Melzack Pain Questionnaire
Timepoint [2] 258000 0
One week prior to commencing intervention (week -1)
At intervention commencement (week 0)
On their fifth treatment (week 3)
Completion of the intervention phase (week 5)
One month follow up assessment (week9)

Eligibility
Key inclusion criteria
Chronic unilateral elbow pain (duration greater than 3 months)
Minimum age
35 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diseases of the central or peripheral nervous system
Radial nerve entrapment
Inflammatory rheumatic diseases
Gout
Radio-ulnar or radio-humeral arthritis
Early episodes of lateral elbow pain treated with surgery or acupuncture
Have a current work cover claim

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243925 0
Other
Name [1] 243925 0
National Institute of Complementary Medicine
Country [1] 243925 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
PO Box 123
Broadway 2007 New South Wales
Country
Australia
Secondary sponsor category [1] 251283 0
None
Name [1] 251283 0
Address [1] 251283 0
Country [1] 251283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244037 0
University of Technology Sydney (UTS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 244037 0
PO Box 123
Broadway 2007 New South Wales
Ethics committee country [1] 244037 0
Australia
Date submitted for ethics approval [1] 244037 0
Approval date [1] 244037 0
21/09/2009
Ethics approval number [1] 244037 0
2009-274A

Summary
Brief summary
This is a pilot study to evaluate whether acupuncture has any effect on lateral epicondyle "tennis elbow" pain as measured by pressure pain threshold and a disease specific questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30417 0
Address 30417 0
Country 30417 0
Phone 30417 0
Fax 30417 0
Email 30417 0
Contact person for public queries
Name 13664 0
Christine Berle
Address 13664 0
University of Technology Sydney
PO Box 123 Broadway 2007
New South Wales
Country 13664 0
Australia
Phone 13664 0
+ 61 418447911
Fax 13664 0
Email 13664 0
[email protected]
Contact person for scientific queries
Name 4592 0
Christopher Zaslawski
Address 4592 0
University of Technology Sydney
PO Box 123 Broadway 2007
New South Wales
Country 4592 0
Australia
Phone 4592 0
+61 2 9514 7856
Fax 4592 0
Email 4592 0
[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
No additional documents have been identified.