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Participants required for hallux osteoarthritis study in Victoria

Discussion in 'Australia' started by Shannon Munteanu, Jan 24, 2008.

  1. Shannon Munteanu

    Shannon Munteanu Welcome New Poster


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    We are looking for participants with first MTPJ osteoarthritis (hallux limitus) to investigate the effectiveness of an anti-arthritis treatment (Synvisc). If you have any patients who you think would benefit from being involved here is some further information.
    Please advise any patients that are appropriate to contact Dr Shannon Munteanu from the Department of Podiatry, La Trobe University on (03) 9479 5866 or email s.munteanu@latrobe.edu.au for more details.

    Please do not hesitate to contact me if you have any queries regarding this study.
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. DaVinci

    DaVinci Well-Known Member

    Shannon - Good luck with the study. I will keep my eyes open in my clinic.

    Is Synvisc something Podiatrists will be able to use at some stage?
     
    Last edited by a moderator: Jan 31, 2008
  4. Shannon Munteanu

    Shannon Munteanu Welcome New Poster

    Hi DaVinci,

    Thankyou.

    Currently Synvisc (hyaluronan) is registered for knee OA in Australia. It is not registered for use for foot and ankle.

    It is best injected intra-articularly using fluoroscopy, as an elevated rate of adverse reactions have been reported if it is injected peri-articularly, rather than intra-articularly.

    However, there have been some studies of recent (and not using fluoroscopy with minimal adverse reactions) that have shown intra-articular hyaluronan reduces symptoms in those with first MTPJ OA/hallux limitus as well as ankle OA.

    The studies for first MTPJ OA are:
    Pons et al. (2007). Foot Ankle Int.; 28(1): 38-42. (abstract shown below)

    Maher & Price (2007). Br. J. Podiatry; 10(2): 47-51. 9abstract shown below)


     
    Last edited by a moderator: Jan 29, 2008
  5. DaVinci

    DaVinci Well-Known Member

    Thanks for the abstracts. Certainly is looking like something Podiatrists might want to do in the future. How is recruitment going?
     
  6. Shannon Munteanu

    Shannon Munteanu Welcome New Poster

    Hi Davinci,

    We have recruited ~60 participants in the past 4 weeks with very minimal advertising. The condition is extremely common and disabling (more common than what I even thought). Most people don't really bother seeking treatment as they feel that there is no treatment that will help apart from surgery. When they see the recruitment posters they are very enthusiastic to be involved as they view their participation as a way to reduce their symptoms. The treatment is free which helps too. The procedure (intra-articular injection) itself takes ~10 seconds and we have had variable responses to the injection from the participants. Some say they experienced no pain whilst others have graded the pain as a ~4 out of 10. None of the participants have had their 1 month review of symptoms as yet so I await this keenly.

    Cheers

    Shannon Munteanu
     
  7. JFAR

    JFAR Active Member

    Efficacy of intra-articular hyaluronan (Synvisc) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus): study protocol for a randomised placebo controlled trial

    Shannon E Munteanu, Hylton B Menz, Gerard V Zammit, Karl B Landorf, Christopher J Handley, Ayman ElZarka, Jason DeLuca

    Journal of Foot and Ankle Research 2009, 2:2

    Abstract (provisional)

    Background
    Osteoarthritis of the first metatarsophalangeal joint (MPJ) of the foot, termed hallux limitus, is common and painful. Numerous non-surgical interventions have been proposed for this disorder, however there is limited evidence for their efficacy. Intra-articular injections of hyaluronan have shown beneficial effects in case-series and clinical trials for the treatment of osteoarthritis of the first metatarsophalangeal joint. However, no study has evaluated the efficacy of this form of treatment using a randomised placebo controlled trial. This article describes the design of a randomised placebo controlled trial to evaluate the efficacy of intra-articular hyaluronan (Synvisc) to reduce pain and improve function in people with hallux limitus.

    Methods
    One hundred and fifty community-dwelling men and women aged 18 years and over with hallux limitus (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to receive a single intra-articular injection of up to 1ml hyaluronan (Synvisc) or sterile saline (placebo) into the first MPJ. The injections will be performed by an interventional radiologist using fluoroscopy to ensure accurate deposition of the hyaluronan in the joint. Participants will be given the option of a second and final intra-articular injection (of Synvisc or sterile saline according to the treatment group they are in) either 1 or 3 months post-treatment if there is no improvement in pain and the participant has not experienced severe adverse effects after the first injection. The primary outcome measures will be the pain and function subscales of the Foot Health Status Questionnaire. The secondary outcome measures will be pain at the first MPJ (during walking and at rest), stiffness at the first MPJ, passive non-weightbearing dorsiflexion of the first MPJ, plantar flexion strength of the toe-flexors of the hallux, global satisfaction with the treatment, health-related quality of life (assessed using the Short-Form-36 version two questionnaire), magnitude of symptom change, use of pain-relieving medication and changes in dynamic plantar pressure distribution (maximum force and peak pressure) during walking. Data will be collected at baseline, then 1, 3 and 6 months post-treatment. Data will be analysed using the intention to treat principle.

    Discussion
    This study is the first randomised placebo controlled trial to evaluate the efficacy of intra-articular hyaluronan (Synvisc) for the treatment of osteoarthritis of the first MPJ (hallux limitus). The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if this form of treatment is found to be an effective treatment strategy. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12607000654459
     
  8. Hylton Menz

    Hylton Menz Guest

    Press release from La Trobe University:

    New drug to help stiff deal for big toes
    19 Jan 2009

    Ignore it, love it or loathe it your big toe is a little multi-tasker. It bends every time you take a step, withstanding stress equal to twice your body mass. And its responsible for providing balance, weight distribution and thrust while you walk.

    [​IMG]

    Unfortunately, this wear and tear can cause osteoarthritis in the big toe joint. The condition is progressive, with the toes range of motion gradually decreasing until it can become stiff, severely hampering your ability to walk.

    In light of this, La Trobe University is conducting a study to see if a new drug, Synvisc, is effective in reducing the pain associated with this condition. The study is looking for people who have experienced pain or stiffness in the big toe joint for at least three months. Each participant will receive a free course of treatment valued at $700.

    Dr Shannon Munteanu from La Trobe Universitys Division of Allied Health Podiatry Clinic says statistics show that 40% of people over 50 have some form of arthritis in their foot, with osteoarthritis in the big toe most prevalent. Sufferers often try alternative medicines ranging from glucosamine tablets to shark cartilage to alleviate pain despite the fact there is little evidence to support the claim that the either is effective.

    "Sufferers are often told there isnt much that can be done about the pain," says Dr Munteanu

    "I describe this new line of anti-arthritic drugs like giving your joints an oil change," says Dr Munteanu. "I think it is the best non-surgical method of treatment at the moment, and has been shown to be effective in two of three recipients with results lasting up to a year."

    Early signs and symptoms of osteoarthritis in the joint of the big toe include pain and stiffness during use aggravated by cold, damp weather, difficulty running and squatting, and swelling and inflammation around the joint. People with fallen arches or excessive rolling in of the ankles are particularly susceptible.

    Participants in the study will be randomly allocated to receive either the anti-arthritis treatment (Synvisc) or a placebo. They will be required to attend three one-hour sessions over six months at the Universitys main Melbourne campus in Bundoora

    If you are interested, please contact Dr Shannon Munteanu, Department of Podiatry, La Trobe University, tel: (03) 9479 5866 or email: s.munteanu@latrobe.edu.au for more details.


    Media enquires: Mikhaela Delahunty on 03 9479 5353
     
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