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Trial registered on ANZCTR


Registration number
ACTRN12613000499785
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
7/05/2013
Date last updated
20/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Effectiveness of LASER Acupuncture on Osteo Arthritic Knee (OAK) Pain: A Randomised, Double Blind, Placebo-controlled Clinical Trial
Scientific title
Evaluation of the Effectiveness of LASER Acupuncture on Osteo Arthritic Knee (OAK) Pain: A Randomised, Double Blind, Placebo-controlled Clinical Trial
Secondary ID [1] 282096 0
Nil known
Universal Trial Number (UTN)
U1111-1140-4573
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 288596 0
Condition category
Condition code
Alternative and Complementary Medicine 288927 288927 0 0
Other alternative and complementary medicine
Musculoskeletal 288968 288968 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An 810nm Class 3B diode LASER with an output of 100mW is irradiate acupuncture points most commonly used to treat osteoartshritis knee pain 3 times a week for 4 weeks (12 treatments, each of 45 minutes duration). Additional acupoints for sub-categories of Phlegm Retention Syndrome and Blood Stasis are used as required.
Intervention code [1] 286701 0
Treatment: Devices
Intervention code [2] 286702 0
Rehabilitation
Intervention code [3] 286703 0
Lifestyle
Comparator / control treatment
For the control group, an inactive LASER is used on the same acupuncture points as those irradiated in the intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 289053 0
WOMAC - to assess osteoarthritis knee symptoms
Timepoint [1] 289053 0
Before and after 12 treatments and at 1 month and 2 months follow-up
Primary outcome [2] 289054 0
VAS - to assess knee pain
Timepoint [2] 289054 0
Before and after each of treatment and at 1 month and 2 months follow-up
Secondary outcome [1] 301645 0
McGill Pain Questionnaire SF-MPQ
Timepoint [1] 301645 0
Before and after 12 treatments and at 1 month and 2 months follow-up
Secondary outcome [2] 301646 0
SF-36 Lifestyle Questionnaire
Timepoint [2] 301646 0
Before and after 12 treatments and at 1 month and 2 months follow-up
Secondary outcome [3] 301647 0
Multi Dimensional Health Locus of Control - Form C (MHLC-C)
Timepoint [3] 301647 0
Before and after 12 treatments and at 1 month and 2 months follow-up
Secondary outcome [4] 301648 0
Working Alliance Inventory Short Form (WAI-S)
Timepoint [4] 301648 0
Before and after 12 treatments and at 1 month and 2 months follow-up
Secondary outcome [5] 301649 0
Credibility & Expectancy Scale (C&E)
Timepoint [5] 301649 0
Before and after 12 treatments and at 1 month and 2 months follow-up

Eligibility
Key inclusion criteria
1. Adults.
2. Meet Western and Traditional Chinese Medicine diagnostic criteria for osteoarthritis knee pain.
3. Have no other serious health condition.
4. Have suffered osteo arthritic knee (OAK) condition for less than 10 years.
5. Have no history of receiving LASER acupuncture treatment for OAK.
Minimum age
35 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Do not fit inclusion criteria
2. Suffering other medical conditions, e.g. multiple sclerosis, diabetes, asthma, dementia, kidney disease, etc
3. Photo (light) sensitivity or on medication that increases photo sensitivity
4. Extensive impaired mobility that would make participation difficult
5. Cognitive abilities that may prevent understanding of study protocols and processes

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. Participants assessed in both Western medicine and Chinese medicine terms.
2. Diagnosed by treating medial practitioner/specialist as suffering from osteoarthritis knee (OAK) pain and graded ats Kellgren-Lawrence Grade 2-3.
3. Assessed by TCM practitioner to ensure OAK syndrome is diagnosed according to most common TCM pattern of Bi Syndrome with sub-patterns of Phlegm Retention in Joints and Blood Stasis in Joints.
4. Participants randomly allocated to treatment or placebo groups via opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
ANOVA and t tests to measure statistical significance

Recruitment
Recruitment status
Completed
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] 6823 0
2000 - Haymarket
Recruitment postcode(s) [2] 6531 0
2000 - Sydney
Recruitment postcode(s) [3] 6530 0
2150 - Parramatta
Recruitment postcode(s) [4] 6824 0
2150 - Parramatta Westfield

Funding & Sponsors
Funding source category [1] 286874 0
University
Name [1] 286874 0
University of Technology, Sydney
Address [1] 286874 0
15 Broadway
Central Sydney NSW 2007
Country [1] 286874 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 285665 0
None
Name [1] 285665 0
Address [1] 285665 0
Country [1] 285665 0
Other collaborator category [1] 277318 0
Individual
Name [1] 277318 0
Meikin Li Rees
University of Technology, Sydney
Address [1] 277318 0
15 Broadway
Ultimo NSW 2007
Country [1] 277318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288935 0
UTS Human Research Ethics Committee
Ethics committee address [1] 288935 0
Research & Innovation Office
Level 14, Tower Building
University of Technology, Sydney
PO Box 123
Broadway NSW 2007
Ethics committee country [1] 288935 0
Australia
Date submitted for ethics approval [1] 288935 0
01/11/2010
Approval date [1] 288935 0
09/12/2010
Ethics approval number [1] 288935 0
UTS HREC 2010-340

Summary
Brief summary
The study tests the effectiveness of LASER acupuncture on osteo arthritis knee (OAK) pain. OAK is the most common form of arthritis.
OAK sufferers and LASER and acupuncture practitioners would benefit from the study in a number of ways. For example, a positive outcome:
1. Would determine an effective LASER acupuncture treatment protocol and influence clinical practice.
2. May help reduce dependency on pharmacological treatments and alleviate associated drug side effects.
3. May reduce the cost and/or financial burden of OA treatment for individuals and the community as a whole.
4. Would help increase awareness about the choice of available treatments.

A negative study outcome:
1. May prove the null hypothesis correct (i.e. LASER acupuncture is not effective for OAK).
2. Would encourage further investigations to test the validity of the study design or develop new experiments.
Trial website
http://newsroom.uts.edu.au/news/2011/03/trial-to-test-laser-acupuncture-treatment-for-osteoarthritis
Trial related presentations / publications
Preliminary results presented at Laser Helsinki International Congress held in Helsinki, Finland, from 24-29 August 2012.
Public notes

Contacts
Principal investigator
Name 38394 0
Dr Peter Meier
Address 38394 0
University of Tecnology, Sydney
Broadway
Central Sydney NSW 2000
Country 38394 0
Australia
Phone 38394 0
61-2-96306388
Fax 38394 0
Email 38394 0
lasertherapy@tpg.com.au
Contact person for public queries
Name 38395 0
Ms Meikin Li Rees
Address 38395 0
University of Technology, Sydney
15 Broadway
Ultimo NSW 2007
Country 38395 0
Australia
Phone 38395 0
61-2-9630-6388
Fax 38395 0
Email 38395 0
lasertherapy@tpg.com.au
Contact person for scientific queries
Name 38396 0
Ms Meikin Li Rees
Address 38396 0
University of Technology, Sydney
15 Broadway
Ultimo NSW 2007
Country 38396 0
Australia
Phone 38396 0
61-2-96306388
Fax 38396 0
Email 38396 0
lasertherapy@tpg.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary