Knee osteoarthritis clinical trial in Australia

The University of Sydney’s ATLAS study is testing and researching a natural treatment for knee osteoarthritis.

This study aims to find out if a new supplement combination can improve knee pain in people with knee osteoarthritis.

The supplement combination contains Boswellia serrata extract, pine bark extract, methylsulfonylmethane, piperine and curcumin.

Recruitment for the study has now closed.

The survey will take approx. 10 mins to complete

What does the study aim to acheive?

Aim 1

To assess how effective a supplement combination is in reducing knee pain in people with knee osteoarthritis over 12 weeks

Aim 2

To determine the safety of the supplement combination compared to placebo over 12 weeks

Who can take part?

The study is suitable for people who:

  • Are aged 40 years or older

  • Have knee pain for more than half of the days in the past month

  • Are willing to maintain a routine (i.e., consistent dosage and frequency) of any other over-the-counter and prescription therapies while on the study

  • Are willing to abstain from any supplements targeting osteoarthritis for the duration of the study

  • • Diagnosis of knee osteoarthritis as defined by the Clinical and Radiographic American College of Rheumatology (ACR) criteria

    • Pain in at least one knee for at least half of the days in the previous month

    • Moderate average knee pain intensity during activities of daily living

    • Radiographic tibiofemoral (TF) and/or patellofemoral (PF) osteoarthritis Kellgren-Lawrence Grade (KLG) 2 or more of the knee

ATLAS knee osteoarthritis study FAQs

  • The ATLAS study may be suitable for you if:

    • Are aged 40 years or over,

    • Have internet access and an active email account,

    • Have had knee pain on most days for the past month or longer,

    • Willing to abstain from any supplements targeting osteoarthritis for the duration of the study,

    • Do not have known hypersensitivity to any of the components of the study product (Boswellia serrata extract, Curcumin, Piperine, Pine bark extract, MSM and Microcrystalline),

    • Do not currently take medications known to have potential pharmacological interaction with any of the supplements being tested,

    • Do not take centrally acting analgesics (e.g. opioid, duloxetine, pregabalin),

    • Have not had an acute injury to the index knee in the past 6 months,

    • Do not anticipate any invasive procedure or surgery on the knee during the study,

    • Have not received Hyaluronic acid or steroid injections in the past six months or regenerative (stem cell) medicine injections in the past 12 months,

    • Are not currently participating in another clinical trial

  • Recruitment for this study is now closed

  • If you are eligible for the study, you will be randomly allocated to either the active group of the placebo group:

    Active group: will receive capsules containing a supplement combination of Boswellia serrata extract, pine bark extract, methylsulfonylmethane, piperine and curcumin.

    Placebo group: will receive placebo capsules containing only microcrystalline cellulose.

    Capsules will be taken for 12-weeks.

    The ATLAS Study is a double-blinded study meaning you and the researchers will not know which group you have been allocated to until after your participation in the study is finished.

  • Over the 12 weeks, we anticipate that your total time commitment for the study will be approximately 3.5 hours to complete all study surveys and procedures.

    During the screening period, you will be required to complete the online screening survey and a knee X-ray (if you have not had an X-ray in more than 12 months).

    This is an online trial which means that all study procedures, including the screening, enrolment, and follow-up assessments will be conducted remotely using online surveys. We will send the study treatment to you by express post.

    You will not pay for any treatment or procedures in this study. All imaging services and postage fees will be free of cost to you.

  • If you are interested in joining the study, please complete the online screening survey by clicking the green button below. The survey consists of approximately 60 short questions and will take about 10-15 mins to complete.

    You can pause the survey at any time and return later by clicking ‘save’. Please take note of the ‘Return Code’ that will display on the screen as you will need this to return to the survey. You will automatically be sent an email with a link to the survey. Once you are ready to continue, please follow the link, and enter your code.

    After you submit the online screening survey and are potentially eligible, study staff will be in contact with you to clarify any of your answers if necessary and explain the next steps of the screening process.

  • If you have questions now or at any point during the screening process or study, please send an email to:

    atlas.study@sydney.edu.au

If you have a question or would like further information about the study, please send an email to atlas.study@sydney.edu.au