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Scalpel debridement in rheumatoid arthritis

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  #1  
Old 14th October 2004, 10:32 PM
Peter Bird Peter Bird is offline
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Question Scalpel debridement in rheumatoid arthritis

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Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial.
Davys HJ, Turner DE, Helliwell PS, Conaghan PG, Emery P, Woodburn J.

Rheumatology (Oxford). 2004 Oct 12

Objective. To compare forefoot pain, pressure and function before and after normal and sham callus treatment in rheumatoid arthritis (RA). Patients and methods. Thirty-eight RA patients were randomly assigned to normal (NCT group) or sham (SCT) scalpel debridement. The sham procedure comprised blunt-edged scalpel paring of the callus which delivered a physical stimulus but left the hyperkeratotic tissue intact, the procedure being partially obscured from the patient. Forefoot pain was assessed using a 100 mm visual analogue scale (VAS), pressure using a high-resolution foot pressure scanner and function using the spatial-temporal gait parameters measured on an instrumented walkway. Radiographic scores of joint erosion were obtained for metatarsophalangeal (MTP) joints with and without overlying callosities. The trial consisted of a randomized sham-controlled phase evaluating the immediate same-day treatment effect and an unblinded 4-week follow-up phase. Results. During the sham-controlled phase, forefoot pain improved in both groups by only 3 points on a VAS and no statistically significant between-group difference was found (P = 0.48). When data were pooled during the unblinded phase, the improvement in forefoot pain reached a peak after 2 days and gradually lessened over the next 28 days. Following debridement, peak pressures at the callus sites decreased in the NCT group and increased in the SCT group, but there was no statistically significant between-group difference (P = 0.16). The area of and duration of contact of the callus site on the ground remained unchanged following treatment in both groups. Following debridement, walking speed was increased, the stride-length was longer and the double-support time shorter in both groups; however, between-group differences did not reach levels of statistical significance. MTP joints with overlying callus were significantly more eroded than those without (P = 0.02). Conclusions. Treatment of painful plantar callosities in RA using scalpel debridement lessened forefoot pain but the effect was no greater than sham treatment. Localized pressure or gait function was not significantly improved following treatment.
What do you make of the conclusion?

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Old 15th October 2004, 03:05 AM
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davidh davidh is offline
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Interesting.
These are fairly small cohorts, but even so, I would have expected to see some difference between the two.
Not an easy study to undertake I would think , and like many research results, would seem to throw up more questions than answers .
Regards,
David
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Old 21st October 2004, 02:28 AM
Alec Mason Alec Mason is offline
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Default Interesting

Interesting conclusion. Could save a few pounds on scalpel blades though I suppose

Alec.
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Old 22nd October 2004, 08:09 AM
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Default Plantar callus debridement

Excellent, much needed piece of research. I'm off to the library to read the full article. Interesting to note those with callosities had more significant joint erosion scores. As far as sample size goes, Woodburn's work on foot orthoses and RA (I think it was published in late 2003) made use of power calculations to suggest appropriate sample size, so it's likely he'll have done the same here, but until I've read the article I can't really say.
Good stuff,
Bob

Last edited by bob : 22nd October 2004 at 08:13 AM.
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Old 24th October 2004, 08:03 AM
Woodburn Woodburn is offline
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Default Scalpel debridement

Dear Colleagues,
Apologies if this appears for the 2nd time as my first messagae didn't seem to make it! Craig Payne asked if I'd make a contribution to this thread so thank you for your interest in this work. If you are unable to access the paper then I can email a pdf copy.
I think Heidi Davys made a good attempt to evaluate a common intervention and be creative methodologically to introduce sham control. To cover some of the issues raised-
1. Sample size was determined from a power calculation based on a previous, unblinded preliminary study [1]. The effect size was large in the preliminary study so the sample needed for this RCT was relatively small. There are fundamental issues using VAS pain scores in sample size calculations and my colleagues in our outcome research group would frown heavily on this practice! We have a new and better outcome tool for RA foot for future RCT's.
2. Yes we were also surprised about the outcome. If you think you were going to see a positive outcome it would be for this type of intervention! The evidence suggests not and it reinforced for us the need to include sham/placebo control for all foot interventions, which are largely physical in nature.
3. The sham control was very important and it seemed to work, as patients not only reported improved symptoms (modest) but also walked faster. Heidi meticulously recorded patient comments during the study and it was very surprising to hear patients adamently state that they had their normal treatment when in fact they were in the sham group.
4. Non-specific behavioural issues heavily influenced these findings and in the future we intend to study new patients and use practitioners unfamiliar to the patients.
5. Why are these patients not sent for FF reconstruction? This question has been thrown at us and in many of these cases motivation for this is not high since most of the patients had received past surgery in the foot and other proximal joints. An economic analysis should also be included in the future to address this issue.
6. Patients seem to be benefitting from a treatment largely consisting placebo effect. Not surprising since the intervention has the features which magnifiy this (skin prep, surgical instruments, cutting, dressings etc).
7. Most important outcome of study for me? Placebo/sham control is essential when evaluating these types of interventions and this may require some interesting strategies in the study design.
Thanks for your interest in this work.
Jim Woodburn

[1] Woodburn J, Stableford Z, Helliwell PS. Preliminary investigation of debridement of plantar callosities in rheumatoid arthritis. Rheumatology 2000;39:652-654.
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Old 7th September 2005, 03:17 AM
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To All,
I had a great time in New Zealand last week.
Arrived back in Wollongong full patient load, thank goodness (pay for all the retail therapy).
Had a patient with RA so typical of the one's Dr Woodburn described in NZ, (ulceration clear exudate 2nd and 3rd met heads). I networked with her G.P. and he agreed that surgery was the one 1 priority. She is due to see her Professor at RNS Hospital (Sydney Australia) next week.
Follow up should be interesting.

Don Scott
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Old 7th September 2005, 03:41 AM
Woodburn Woodburn is offline
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Default Callus debridement

To Don ESWT,
Just arrived back in the UK and also thoroughly enjoyed the Christchurch meeting. I think your plan of action is spot on. Now the callus sites are starting to ulcerate, like the diabetic foot, this will be the strongest predictor for future ulceration so a surgical opinion is warranted. Good luck and I'd be keen to know what the eventual outcome is.
Best wishes,
Jim Woodburn
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Old 10th September 2005, 12:15 AM
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Dr Woodburn,
I have a pre op cast of both feet in all their glory. I hope to report that my patient's case is rushed through for surgery via main stream medicine. Failing that maybe one of the Australian Podiatric Surgeons can help me advise my patient of a faster route.

On another point your 3D MRI was interesting. I am also involved with CT Light Speed 16. In less than 11 second over 1,000 images were taken, from the A/P and M/L views, a 3D image was reproduced. Within a few months a few months a new generation of software will be introduced (How can we keep up with the technology).

Radiology imaging is very important for the diagnosis of foot complaints. We have to lobby the Federal Government to allow Podiatrists more detailed imaging techniques. (eg Ultrasound, CT Scan and MRI)

Don Scott
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Old 22nd September 2005, 04:03 AM
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Dr Woodburn,
Patient is now on short list if she wishes to accept

Don Scott
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