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SCUlpTOR study - Stem cell injections for knee osteoarthritis

What is this study about?

The SCUlpTOR trial is a research study aiming to see if stem cells injected into the knees of people with knee osteoarthritis (OA) can improve their symptoms compared with placebo. The medical opinion about stem cell therapy for treating osteoarthritis is mixed due to limited research evidence and considerable costs. So our aim is to find out whether or not stem cell injections into the knee improve symptoms and slow disease progression in people with mild to moderate knee OA. The stem cells we use originally came from a healthy donor/master cell bank and are made following standard manufacturing process to make sure they are safe and standardised.

If the study is suitable for you, you will have a 50% chance of being allocated to either group and receive:

Active group: three knee intra-articular injections of allogeneic MSCs (stem cells) performed at baseline, week 3 and 52.

Placebo group: three knee intra-articular injections of saline performed at baseline, week 3 and 52.

As a participant, you will be asked to attend seven study visits and complete online surveys regularly over 24 months.

The study is suitable for people who:

  • Are aged 40 years or older and living in Australia (and have a Medicare number)
  • Have knee OA and moderate pain assessed by the visual analogue pain intensity scale from 0 (no pain) to 100 (worst pain possible)
  • Have internet access and an active email account
  • Are willing to stop or maintain knee OA treatments (e.g. supplements, physiotherapy) for the duration of the study
  • Are willing to stop or minimise the use of anti-inflammatory drugs (e.g. Aspirin, Nurofen, Ibuprofen, Mobic, Voltaren, etc.) and other analgesics (e.g. opioids), except for paracetamol (only for rescue pain relief) for the duration of the study. This includes stopping all pain medications for one week before each study assessment.
  • Able to speak and read English sufficiently to understand study procedures, complete questionnaires and provide informed consent.
  • Are willing and able to travel for the study required physical visits.

Study Safety

This study has been approved by the University of Sydney (2020/119) and the University of Tasmania’s (21868) Human Research Ethics Committee (HREC).

Am I eligible?

If you have knee pain due to osteoarthritis and live in Sydney or Hobart, please complete the online screening survey available at www.tinyurl.com/sculptor-trial to assess your eligibility.

SUcceSS: SUrgery for Spinal Stenosis – A world-first randomised, placebo-controlled trial of decompression surgery for central lumbar canal stenosis

 

 

 

Professor Manuela Ferreira, from the University of Sydney, is leading researchers across NSW and Victoria in a world-first randomised placebo-controlled study to investigate the role of decompression surgery for central lumbar canal stenosis – the SUcceSS study. Lumbar canal stenosis is a leading cause of pain and functional disability in older adults. It is commonly managed  with  decompressive  surgery  when  conservative  care  fails  to  result  in  satisfactory  clinical improvement.

Evidence  to  date  supporting  decompressive  surgery  is  inconclusive  and mainly based  on results  of  unblinded  randomised  trials  with  high  crossover  rates  which  are  prone  to  bias.  Placebo-controlled  surgical  trials minimise the potential  for bias and  provide  more  robust  estimates  of  treatment effects. They control for the influence of placebo effects associated with surgery. The SUcceSS study will attempt to provide solid evidence as to how well decompression surgery works.

160 participants with symptomatic lumbar spinal stenosis will be randomised into one of two groups – spinal decompression surgery or placebo spinal surgery (the same as spinal decompression but without removal of bone). Although this is a frequently performed procedure, there is poor evidence to confirm its efficacy.

Who is eligible?

  • aged ≥ 40 years
  • have neurogenic claudication (pain or numbness in the legs or buttocks) that is worse with walking and better when siting or leaning forward
  • have symptoms which have been present for at least 3 months
  • have not improved with non-surgical management
  • are eligible, and medically fit, to receive decompression surgery (single or dual level)

SUcceSS Surgeons from Sydney and Melbourne public and private hospitals will assess participants suitability based upon strict inclusion and exclusion criteria.  Before  being  included  in  the  study,  all  potential  participants  are  comprehensively  counselled  by  their surgeons and the research team about the study purpose and procedures to ensure that they understand what is involved and can provide informed consent. Study participants are then closely monitored by the research team over a two-year period after surgery to ensure patient safety and to monitor recovery.

Study Safety

SUcceSS has been ethically approved by the SESLHD HREC (HREC/17/POWH/601), is  funded  by  the  NHMRC,  has  received  additional approval  to recruit participants from  multiple  sites, and  has strong  governance  processes in  place  including  a high  level of  external safety  monitoring  to  ensure  the wellbeing  of  all involved.

How can I get more information?

Click here for more information about the SUcceSS study or contact the SUcceSS research team (Professor Manuela Ferriera and Ms Joanna Prior) by phone (02) 8627 7228 or email ibjr.success@sydney.edu.au

Does your general practice manage patients with Type 2 diabetes as well as cognitive impairment or dementia?

Seeking expressions of interest – Impact of memory changes on consumer engagement and provider support in the self-management of diabetes type II

Target audience: general practice, practice nurses

 

Background

Sydney North Health Network (SNHN) is collaborating with the Universities of Notre Dame Australia, University of Newcastle and the University of New South Wales to undertake a qualitative exploratory study. The study aims to explore the factors involved in the self-management of diabetes by people over 65 years whom are also living with cognitive impairment or early stage dementia from the perspectives of the consumers, cares/significant  other/responsible person and primary health clinicians.

 

SNHN are seeking expressions of interest from GPs and PNs interested in supporting the recruitment of consumer/patients to the study and taking part in a semi-structured interview.

 

Benefits for general practice

The findings of the study will inform care planning and ongoing self-management support actions required to meet the needs of this vulnerable group of patients. The Practice will receive an incentive payment for participation.

 

What is expected of participating General Practices:

  • Practice Nurse/Manager to audit list of patients supported by SNHN and the use of the *CAT4 tool for eligibility to participate in the study; and GPs to confirm eligibility of patients
  • GPs to confirm patient ability to provide an informed consent
  • Practice Nurse/Manager to disseminate study packs (Participant Information Sheets and Consent form) to support the research teams arms-length approach to recruitment
  • Participate in a brief semi-structured interview

 

Patient inclusion criteria

  • Diagnosis of Diabetes Type 2 at least 6 months
  • Diagnosis of Cognitive Impairment or Dementia

 

How to express interest
If you are interested in supporting this study, please email sbarry@snhn.org.au with the following details:

  • Practice name
  • Contact person
  • Practice address
  • Postcode
  • Phone
  • Email

For further information please contact sbarry@snhn.org.au or phone 9432 8250.

*CAT4 tool is the PenCS data extraction tool for general practice – Sydney North Health Network will arrange installation if you do not have the tool.

OASIS: Oral Steroids in Sciatica Study

Researchers at the University of Sydney seek GPs’ help in finding a simple, low cost, first line treatment for patients with acute sciatica.

 

Aim

To investigate if oral glucocorticoids compared to placebo:

  • Reduce leg pain intensity in patients with acute sciatica.
  • Improve other outcomes e.g. disability, back pain
  • Are safe and cost effective

 

What will GPs need to do?

Identify, screen and consent eligible patients with acute sciatica

Monitor patient condition, medication and adverse events during treatment.

You will receive an honorarium for your time

 

Contact us

Phone: (02) 8627 6267

Email: sph.opal@sydney.edu.au

Fax: (02) 8624 4746

The PARTNER project: Optimising primary care management of knee osteoarthritis

Do you want to be involved in a study that will improve your skills in the management of knee osteoarthritis (OA)?

The PARTNER project team would like to invite you to participate in trialing a new model of service delivery using evidence based non-surgical treatments.

Depending on the group allocated to you, you could benefit by:

• Access to RACGP Online training models updating the most recent evidence for non-surgical OA interventions
Patient support from a multidisciplinary team (Physiotherapists, Exercise Physiologists and Occupational Therapists) for 12 months
• Free cdmNet software and training (chronic disease management software)
• Opportunity for 40 category 1 RACGP QI & CPD points
$500 per practice
• $100 per participating GP

Benefits to patients in the study include:

  • Tailored, evidence based support from a multidisciplinary team over a 12 month period
  • Telephone or email-based support including:
    • Self-management education
    • Individualised exercise and strengthening program
    • Weight loss intervention (if required)
    • Advice and support on OA management

Practice eligibility criteria:

  • A minimum of one GP in the practice willing to participate

If you are interested in participating in the PARTNER study, please respond to this expression of interest.

If you have any questions contact project officer Carin Pratt by email carin.pratt@sydney.edu.au or phone 0407 051 641

This study is a RCT funded by the National Health and Medical Research Council.

CLICK HERE FOR THE PARTNER PROGRAM INVITATION LETTER

Investigating current and future education and training needs of the Australian workforce in genomic medicine

Northern Sydney LHD invite general practitioners to participate in a NH&MRC-funded study that is gathering perspectives on current and future education and training of the Australian workforce in genomic medicine.

They are interested in identifying gaps and opportunities in education and training activities for the general practitioner workforce in genomic medicine, and gaining a better understanding of the needs of those involved in delivering genomics in health care.

Participation would involve an interview for up to one hour with payment of $120 per hour (pro rata), at a time and place convenient to you, face-to-face (including virtual technology) or via telephone, and either individual or in a group. They may also contact you to clarify some points after the interview; if so, this would be by phone or email.

If you are interested in participating, please contact the Project Officer, Marie Brigitte Cusack, phone
(02) 9462 9594 or email: marie.cusack@health.nsw.gov.au, who will send you a detailed Plain Language Statement and Consent Form.

Investigating the use of information search tools to perform medical tasks

What is the purpose of the research?

Researchers from CSIRO (Australian eHealth Research Centre) and Queensland University of Technology are conducting a user study to test a search engine designed to provide clinicians with succinct, accurate and evidence-based information for clinical decision making. The purpose of the study is to better understand clinician needs and behaviour whilst resolving a clinical problem, and ultimately to provide a better system to support improved patient outcomes.

Are you looking for people like me?

The research team is looking for: Registered clinicians including GPs, nurses and hospital clinicians, who are accustomed to using search engines, understand the concept of evidence based medicine and have access to a computer connected to the internet.

What will you ask me to do?

Participation will involve completing 16 clinical question tasks using a custom medical literature search application, plus a pre-test/post-test questionnaire. The test can be performed remotely from a computer if you have access to the internet with either Firefox or Chrome search engines. The whole test should take take approximately 2 hours of your time and must be performed in a single sitting. In the first stage of the test you will be provided with a series of clinical scenarios which you must provide your answer to. In the second stage, for each task, you will have a maximum of 10 minutes to do the following:

  1. Read the description of a health case.
  2. Answer the clinical question, associated with the case using your own knowledge (i.e., without performing any search).
  3. Use the provided search technology as instructed to search for information related to the given health case.
  4. When you have sufficient information to complete the task, or the task time limit has been reached, enter your answer.

Before and after the test you will be asked a series of questions relating to personality traits, search and medical experience and skills and other demographic information. All of this information is gathered anonymously.

Are there any risks for me in taking part?

The identified risks that might affect you when participating in this research is inconvenience and/or feelings of failure. Inconvenience will occur as you will be requested to spend your time searching and entering information on a computer. The likelihood this risk will occur is medium and the severity of the risk is low. Feelings of failure may occur if you feel unable to complete the whole test in the time allotted or unable to answer particular questions. The likelihood this risk will occur is low.

Are there any benefits for me in taking part?

You have the option of receiving your decision scores in relation to the other sample results received for self-reflection purposes. In the longer run, your study results can contribute to research findings that may be incorporated into future clinical decision support applications. You will also receive a copy of any published results relating to this study.

Will I be compensated for my time?

To recognise your contribution should you choose to participate and complete the study, the research team is offering you a $50 gift card.

I am interested – what should I do next?

If you would like to participate in this study, you can contact the researcher for details of the next step:

Anton van der Vegt anton.vandervegt@hdr.qut.edu.au

You will be provided with further information to ensure that your decision and consent to participate is fully informed.

Development and validation of computer software to aid medication management for people with and without dementia, and their carers

Researchers at the Cognitive Decline Partnership Centre at the University of Sydney are developing and validating computer software to be used by Residential Aged Care Facility (RACF) staff to identify and document patient treatment goals and specifically preferences for medications. The computer software is designed to guide the management of medications for people with and without dementia. For example, to identify medicines that can be withdrawn or may need to be started. It can be used in addition to other software programs.

Researchers are seeking RACF Managers, Nurses and Assistants in Nursing to obtain perspectives on the need for and use of the computer software.

Eligibility criteria for participants:

  • Current Australian RACF Manager, Registered nurse or Assistant in Nursing
  • More than two years experience working in RACFs
  • Experience in medication management for persons with or without dementia
  • English Speaking

Eligible participants will be involved in two 1-hour focus group or interview sessions.

If you are interested in facilitating recruitment of participants in this important research and would like to receive an information pack, please contact Mouna using the details below:

Mouna Sawan
(02) 9926 4927
ncs.researchdbi@sydney.edu.au

Research project for 2018 "Agents of Change" Dementia Clinical Practice Guidelines Implementation

Become an Agent of Change! Join an online Collaborative with other professionals and be supported to develop your own action plan to improve access to either occupational therapy, exercise, or carer support (professionals can choose one of these).

Agents of Change is a research project recently funded by the National Health and Medical Research Council and the Cognitive Decline Partnership Centre. The project aims to improve the implementation of three key recommendations from the Clinical Practice Guidelines for Dementia in Australia:

  1. ‘People living in the community should be offered occupational therapy (reflecting evidence based programs)’
  2. ‘People with dementia should be strongly encouraged to exercise’
  3. ‘Carers and family should have access to programs to support and optimise their ability to provide care for the person with dementia, including respite’

The project is designed to be ‘light touch’ and to give clinicians the autonomy to make changes that are sustainable for them.

Participating will fulfill a year’s worth of CPD requirements for almost all professions (we can help clinicians to confirm this with their professional body) and clinicians will receive a $1000 stipend to present their work at a conference or meeting of their choice. Professionals can work anywhere in Australia as the program is all online.

Learn More: please contact Monica Cations (trial coordinator)
phone: (08) 8275 2827 or email monica.cations@flinders.edu.au

SKAI System Testing: A pilot study to test the feasibility of the SKAI package

The SKAI (Sharing Knowledge About Immunisation) team is looking for General Practices in Sydney to take part in an innovative vaccination communication project.

What is the study about?

We would like to invite your practice or clinic to take part in a research project titled SKAI System Testing: A pilot study to test the feasibility of the SKAI package. The SKAI system is a suite of resources for health professionals and parents/carers of babies and young children, designed to support and improve clinical conversations about childhood vaccination. This study will investigate whether the SKAI system can be integrated into established clinical work flows and consultations.

What is the aim of this study?

The aim of this study is to test the SKAI system – a vaccination communication and resources package – as it is intended to be used and modify it to ensure it is acceptable to all practice staff and patients, easy to use during and around consultations, and valuable to vaccination providers.

To participate in this study

To find out more or if you would like to express interest in participating in this very exciting vaccination project, please contact Penelope.Robinson@sydney.edu.au (02 9114 1311) or Nina.Berry@sydney.edu.au (02 9114 1327).

Health professionals who participate in the SKAI training will earn CPD points. Participating clinics will be offered a reimbursement fee to help cover the administrative costs involved in taking part in the study.

For more information, please visit:

https://www.skaiproject.org/
http://www.ncirs.edu.au/research/social-research/skai-project/

General Practices in the SNHN region wanted for research study on new primary healthcare initiatives

Research subject heading: Understanding the challenges to implementing new primary healthcare initiatives in general practice, and the factors which promote or inhibit successful implementation, embedding, and integration of initiatives.

Researchers at The University of New South Wales, working with the Sydney North Health Network (SNHN), are seeking volunteer research participants to examine general practice experiences of implementing primary healthcare initiatives and identifying factors needed for successful implementation and integration of interventions into routine work. The study is based on qualitative semi-structured interviews with a sample of general practices as they undertake new primary healthcare initiatives.

Would this research project be a good fit for me?

The study might be a good fit for you if your practice is currently engaged in one of the following SNHN primary healthcare initiatives:

  • Data quality improvement that has incentives attached to deliverables – using Pen CATPlus data extraction tool for quality improvement in the practice;
  • The Person Centred Medical Home program, designed to support practices to build capacity within the practice for team-based working; and
  • Practiced based chronic disease management, Wellnet program, including risk stratification and care coordination.

How to express interest
Please read and complete the Participant Information Statement/Registration Form below and email to research@snhn.org.au.

Participants needed for a smokers’ study

The George Institute for Global Health is seeking participants for a clinical trial to determine whether early intervention with long acting bronchodilators, could slow down lung function decline in smokers who are at a high-risk of developing chronic obstructive pulmonary disease (COPD).

Researchers are seeking current smokers aged 25 – 45, with over 10 pack years smoking history and normal lung function. We will offer smoking cessation. This study has Human Research Ethics approval, reference HREC/15/HAWKE/489. For information click on http://www.ANZCTR.org.au/ACTRN12616001208493.aspx.

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GP participation opportunity in University of Sydney research focus groups

Researchers at the Cognitive Decline Partnership Centre at the University of Sydney are developing and validating a computerised clinical decision support system to be used during medication review for people with and without dementia.

Researchers are seeking General Practitioners with experience conducting medication reviews for people with and without dementia who would be willing to participate in a focus group or interview to contribute to the development of the new software. Eligible participants will be involved in two 1-hour focus group or interview sessions during the development of the software

Enquiries: If you are interested in participating in this important research, contact Dr Lisa Kouladjian O’Donnell at lisa.kouladjian@sydney.edu.au or (02) 9926 4934 for a copy of the participant information sheet and other details.

For more information, click here.