Evaluation of the Effectiveness of LASER Acupuncture on Osteo Arthritic Knee (OAK) Pain: A Randomised, Double Blind, Placebo-controlled Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000499785

Enrollment

Registered

2013-05-07

Start date

2011-05-31

Completion date

2012-09-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

35 Years to 80 Years

Healthy volunteers

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.

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

Outcome results