Welcome to the Podiatry Arena forums, for communication between foot health professionals about podiatry and related topics.
You are currently viewing our podiatry forum as a guest which gives you limited access to view all podiatry discussions and access our other features. By joining our free global community of Podiatrists and other interested foot health care professionals you will have access to post podiatry topics (answer and ask questions), communicate privately with other members (PM), upload content, view attachments, receive a weekly email update of new discussions, earn CPD points and access many other special features. Registered users do not get displayed the advertisments in posted messages. Registration is fast, simple and absolutely free so please, join our global Podiatry community today!
If you have any problems with the registration process or your account login, please contact contact us.
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.
Quote:
The purpose of this letter is to inform you of a research project commencing in March 2008 titled;
“The effectiveness of intra-articular hyaluronan (Synvisc®) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus)”.
As you are aware, osteoarthritis of the first metatarsophalangeal joint of the foot (hallux limitus) is extremely common and can be recalcitrant to conservative treatment. Hyaluronan is a naturally occurring lubricator found in all synovial joints. In osteoarthritis, its concentration within the synovial joint is reduced and this is associated with symptoms of joint pain and disability. Intra-articular injections of hyaluronan are designed to replace the synovial fluid and therefore, improve pain and function in joints affected with osteoarthritis. However, there are few well designed studies that have investigated the effects of hyaluronan on joint pain and stiffness in those with hallux limitus.
Therefore, the aims of this project are to:
(i) determine the effectiveness of hyaluronan (Synvisc®) versus a placebo on foot pain and function in people with hallux limitus;
(ii) to determine the effect of hyaluronan (Synvisc®) versus a placebo on the range of motion of the first metatarsophalangeal joint and strength of the plantarflexor muscles of the first metatarsophalangeal joint in people with hallux limitus.
We are seeking to recruit participants for our study and would appreciate if you could inform any of your patients of the study if you think they are suitable candidates.
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.
Re: Participants required for hallux osteoarthritis study in Victoria
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)
Pons et al. (2007)
Sodium hyaluronate in the treatment of hallux rigidus. A single-blind, randomized study.
Pons M, Alvarez F, Solana J, Viladot R, Varela L.
BACKGROUND: The purpose of this study was to evaluate the effectiveness and safety of intra-articular sodium hyaluronate (Ostenil)mini) compared to intra-articular triamcinolone acetonide (Trigon depot) in the treatment of painful hallux rigidus. METHODS: Thirty-seven patients (ages 40 to 80 years) with painful early stage hallux rigidus were enrolled in the study. One group received an intra-articular injection with 1.0 ml sodium hyaluronate (SH); the other received an intra-articular injection of 1.0 ml triamcinolone acetonide (TA). Patients were evaluated on days 0, 14, 28, 56 and 84. Effectiveness was measured using the following parameters: joint pain at rest or on palpation (VAS), with passive motion, and gait pain; AOFAS hallux metatarsophalangeal score; use of analgesics and global assessment of the treatment by the patient and investigator. Safety was evaluated by the outcome of tolerance to treatment and observation of adverse events. Statistical analyses were performed using the Chi-square test, Mann-Whitney U test, Wilcoxon test and Friedman test. RESULTS: Thirty-seven patients (40 feet) were evaluated. Pain at rest or with palpation and pain on passive mobilization decreased significantly in both treatment groups in comparison to baseline (p<0.01), but no significant between-group differences were observed (p>0.05). Gait pain improved substantially in the sodium hyaluronate group with significant differences compared to the triamcinolone group at days 28 and 56 (p<0.05). The AOFAS total score improved significantly in the SH group compared to the TA group (p<0.05). This was mainly due to improvements in the pain subscale. No between-group differences were seen regarding the use of analgesics. Global assessment of treatment by patients was good in both groups, and there was a significant between-group difference favoring SH when areas under the curves (AUC) were calculated (p < 0.05). Tolerance was good in both groups. Adverse events occurred in three patients. CONCLUSIONS: Intra-articular injections of sodium hyaluronate are effective and safe in decreasing hallux rigidus pain. The AOFAS scores in the SH group were significantly better than in the TA group
Quote:
Maher & Price (2007):
Sodium hyaluronate injections have been used by a community podiatric surgery service for the past 18 months. A retrospective audit was undertaken to determine the value of intra-articular sodium hyaluronate injections when administered for painful limitation of first metatarso-phalangeal joint motion. Visual analogue scales (VAS) were issued to 16 patients. Data from 14 patients were available for this study. Joint pain was recorded utilising a VAS based on a 10cm line. The average pre-injection VAS score was 6.2cm (range 1-9), and the average post-injection VAS score was 2.8cm (range 0-8.5). Duration of benefit was variable, with one patient reporting no benefit' while three (23%) reported less than one month of pain relief. A further three patients (23%) reported less than months of pain relief, while six (46%) had continued pain relief at 6 months following the final injection Sodium hyaluronate injections were found to be safe with no serious adverse reactions reported Although further investigation would be necessary to determine the true value of such treatment, in this very small retrospective study, sodium hyaluronate injections do appear to offer relief from first metatarso-phalangeal joint pain
Last edited by Admin : 28th January 2008 at 08:28 PM.
Reason: fixed quote
The Following User Says Thank You to Shannon Munteanu For This Useful Post:
Re: Participants required for hallux osteoarthritis study in Victoria
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.
Re: Participants required for hallux osteoarthritis study in Victoria
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
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
__________________ Open Access - all papers full text for free
Re: Participants required for hallux osteoarthritis study in Victoria
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.
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
Participants required for hallux osteoarthritis study in Victoria
Linear Mode
