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Study protocol
Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trial
Bill Vicenzino , Natalie Collins , Kay Crossley , Elaine Beller , Ross Darnell and Thomas McPoil BMC Musculoskeletal Disorders 2008, 9:27doi:10.1186/1471-2474-9-27
Quote:
Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy.
Methods
A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18-40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.
Discussion
The randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions. Trial registration : ACTRN012605000463673 ClinicalTrials.gov NCT00118521
Re: Foot orthoses and patellofemoral pain syndrome
Quote:
Originally Posted by NewsBot
Study protocol
Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trialBill Vicenzino , Natalie Collins , Kay Crossley , Elaine Beller , Ross Darnell and Thomas McPoil
BMC Musculoskeletal Disorders 2008, 9:27doi:10.1186/1471-2474-9-27
Re: Foot orthoses and patellofemoral pain syndrome
The full results of this study are eagerly awaited. A sneak peak at the results at last yrs SMA mtg showed the foot orthotic group did better than the placebo group, which is a relief in the context of:
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Re: Foot orthoses and patellofemoral pain syndrome
hi- I'm a final year pod student currently swimming in piles of journals as i write up my lit review (on mcconnell taping vs orthoses in the contol of PFPS). I'm interested in what was said about the preliminary results of the new RCT - is there anything in writing i could look at (or quote!) and when are the full details expected.
Re: Foot orthoses and patellofemoral pain syndrome
Nothing in writing released by researchers yet.
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Re: Foot orthoses and patellofemoral pain syndrome
Hopefully this is a case of turning anecdotal evidence into research based evidence. There are so many areas like this within orthotic therapy. Will we ever get all the bases covered? I only wish I had the research abilities to help.
I'm very keen to see the results of this study. When are the results due Craig?
Re: Foot orthoses and patellofemoral pain syndrome
Quote:
Originally Posted by dmulkeen
Hi folks, any news on this yet?
AFAIK, its still under review at BMJ.
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Re: Foot orthoses and patellofemoral pain syndrome
Quote:
Originally Posted by dmulkeen
Hi folks, any news on this yet?
The full text of the results are now available:
Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial.
Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. BMJ. 2008 Oct 24;337:a1735. doi: 10.1136/bmj.a1735.
Quote:
OBJECTIVE: To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.
DESIGN: Prospective, single blind, randomised clinical trial. SETTING: Single centre trial within a community setting in Brisbane, Australia. PARTICIPANTS: 179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks' duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.
INTERVENTIONS: Six weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.
MAIN OUTCOME MEASURES: Global improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.
RESULTS: Foot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66, 99% confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.
CONCLUSION: While foot orthoses are superior to flat inserts according to participants' overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.
Re: Foot orthoses and patellofemoral pain syndrome
Interesting to hear the results of that one. I spent a few months immersed in knee pain and orthoses literature for my dissertation.
However, it is frustrating that there is little evidence out there of casted orthoses (in a randomised trial) in treating knee pain. Its obviously easier to do studies on off-the-shelf stuff, but we need to advance our knowledge of custom FO as well.
Anyone heard of any studies in the pipeline to look at this?
Re: Foot orthoses and patellofemoral pain syndrome
Quote:
Originally Posted by matt owen
However, it is frustrating that there is little evidence out there of casted orthoses (in a randomised trial) in treating knee pain.
I agree Matt. I saw this paper presented at the recent Sports Medicine Australia conference. It's frustrating that OTC orthoses were used for this trial but then in the discussion they talked about "orthotics". I would have liked them stick with the terminology OTC orthoses or something similar throughout.
In this trial they compared the "gold standard" physiotherapy approach to an OTC orthotic. Obviously we'd like to see a similar study with custom foot orthoses (i.e. everyone gets a customised prescription, not just a casted orthotic all made from subo with a 4 deg RF post) but then everyone is really getting a different treatment - not a RCT. What's the answer???
Finally, can we assume that custom foot orthoses would do a better job for anterior knee pain than OTC orthotics? Also, I'd like to see a cost-benefit analysis done - if foot orthoses do as good as physio, can we do it cheaper?
Re: Foot orthoses and patellofemoral pain syndrome
There has been an interesting, informative and educational exchange on this study in the BMJ:
In the same edition as the original study was this editorial: Editorial
Patellofemoral pain syndrome
Usually resolves over time, and intervention offers only limited benefit
C Niek van Dijk and Willem M van der Tempel BMJ 2008; 337: a1948
Quote:
Patellofemoral pain syndrome is defined as pain behind or around the patella caused by stress in the patellofemoral joint. Symptoms are usually provoked by climbing stairs, squatting, and sitting with flexed knees for long periods of time. It is a common presentation in general practice and can have a big effect on patients’ ability to work.1 Physiotherapy and foot orthoses available without prescription are often used in the management of patellofemoral pain syndrome. In the linked randomised controlled trial (doi:10.1136/bmj.a1735), Collins and colleagues assess the effectiveness of foot orthoses, flat insoles, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or a combination of foot orthoses and physiotherapy in people with this syndrome.2
The rationale for treatment is to correct unbalanced tracking of the patella. Knee braces, knee taping, knee sleeves, and knee straps all aim to alter the patella’s tracking pattern. Some studies have shown that these strategies improve knee symptoms, although others show no significant difference compared with physiotherapy.3 4 The most commonly recommended treatment is strengthening of the quadriceps along with avoidance of painful activities.5 Straight leg raises are recommended to isometrically strengthen the quadriceps. One cohort study found that increasing hip muscle strength and flexibility has also been successful.6 In this cohort study, after six weeks of hip exercises, improvement of hip muscle function was associated with good results in patellofemoral pain syndrome.
In patients with a flat foot deformity, the foot is pronated causing a compensatory internal rotation of the lower extremity that can disturb the patellofemoral mechanism. In this situation custom made foot orthoses are used to support the medial arch and restore normal leg alignment. Foot orthoses, in addition to an exercise programme, can be effective for people with patellofemoral pain syndrome.7 On the other hand, a recent randomised trial showed no difference in outcome between eight weeks of treatment with functional foot orthoses, exercises, or orthoses combined with exercises.8 Follow-up beyond eight weeks was not available in either of these studies, which limits their value, because patellofemoral pain syndrome tends to become a chronic problem.
The linked study by Collins and colleagues randomised 179 patients with patellofemoral pain syndrome to four interventions of six weeks’ duration.2 The flat insole group can be regarded as a control for the foot orthoses.9 Global improvement, severity of usual and worst pain over the preceding week, the anterior knee pain scale, and the functional index questionnaire were measured at six, 12, and 52 weeks. Foot orthoses significantly improved outcomes at six weeks compared with flat inserts (relative risk 0.66, 99% confidence interval 0.05 to 1.17; number needed to treat 4, 2 to 51). At six weeks patients using foot orthoses or those who performed a supervised exercise programme showed significant improvement compared with those using flat insoles. This study confirms the good results seen for exercise and foot orthoses in the short term.3 At one year follow-up, all groups, including the one using flat insoles, showed a clinically meaningful improvement.
A systematic review found that exercise programmes consisting of either closed chain exercises (where the foot is in contact with a surface) or open chain exercises (where the foot is not in contact with a surface) are equally effective.10 So far, the role of foot orthoses has not been clear. A recent systematic review found no evidence to support the use of any orthotic devices in the treatment of patellofemoral pain syndrome.4 Collins and colleagues’ study suggests that foot orthoses can be useful in the short term. They may even be cost effective compared with physiotherapy.
The study also found that all groups, including the placebo group (flat insoles) made a clinically relevant improvement over time. This probably reflects the benign natural history of this syndrome, and raises the question of whether we should interfere at all. High quality randomised controlled trials are needed to answer this question. These should compare the results of knee orthoses, foot orthoses, physiotherapy, and patients without treatment; follow-up should be for at least a year. The limited evidence for the effectiveness of orthotic devices for patellofemoral pain syndrome along with the current results should encourage future researchers to use a control group not receiving any treatment
This was the response from the authors: Patellofemoral Pain Syndrome: Important Considerations
Quote:
Professors van Dijk and van der Tempel[1] have written a good overview of the topic area, our clinical trial[2] and the need for future work to incorporate a no-treatment control group. We would like to comment on a few of the points they raise in their editorial.
1. The relationship between flat foot deformity and patellofemoral pain syndrome is a widely held clinical notion/observation that is not strongly supported by research (e.g., [3 ,4]). As such, we were careful not to endorse this association in our write-up, and encourage readers to exercise care when taking this point on board. Aside from there being little concrete evidence of the link between flat feet and patellofemoral pain syndrome, there is also the issue of a lack of consistent and solid evidence underpinning the notion that orthoses support the arch and control excessive pronation (flat feet) and thus alignment of the lower limb and patella. Our clinical trial shows that foot orthoses with inbuilt arch support and inversion (supination/varus) wedging/posting are superior to flat shoe inserts made of the same material. We feel that this provides evidence that there is some therapeutic property in the shape and contouring of the orthoses. This requires further evaluation, so that the therapeutic characteristics and underlying mechanisms of action of foot orthoses become more evidence-based.
2. We have recently published a follow up study that may provide some support for the notion that the orthoses are likely to be more effective in specific individuals[5]. In this study we detail a clinical prediction rule in which 3 of the following 4 patient characteristics can be used to improve the likelihood of marked improvement at 12 weeks from 40% to 85%: (i) age > 25 years, (ii) height < 165cm, (iii) pain severity < 53mm on 100 mm VAS, and (iv) mid-foot width difference from non weight bearing to weight bearing > 11mm. The mid-foot width difference of > 11mm, which can be easily measured with a vernier caliper[6], identifies those who have greater mobility of the foot when it is loaded in weight bearing, which is a component of excessive foot pronation. This may provide some support to the notion enunciated in 1 above.
3. The need for future studies to include a group which follows a 'wait and see policy', as in previous randomised clinical trials (RCTs) of musculoskeletal pain[7 ,8], is a valid point and one we support in principle. Enacting such arms of RCTs is often perceived to be an impediment to recruitment and gaining ethical approval, and may compromise the trial‚s successful completion. Notwithstanding this, it is important to understand that the natural history of many musculoskeletal pain states (or time course of resolution of acute bouts of pain) are largely not described and so it is difficult to know if some minimal attempt at intervention (e.g. flat insert) is better than just waiting for resolution. If we assume that flat inserts provide some Œplacebo effect‚ beyond natural resolution in the short term, then the use of foot orthoses is likely to speed up resolution beyond that of natural recovery. Many of our patients present to clinics with patellofemoral pain that has not resolved, often after a period of waiting and seeing, and for which they are seeking a speedy resolution of their pain and subsequent return to pain-free function. In this regard, the findings of this study, and previous studies that show physiotherapy to be more effective than placebo in the short term, provides solid direction to both the patient and practitioner in their quest to return as soon as possible to pain-free participation in life.
4. The editorial makes two pertinent statements, that patellofemoral pain „usually resolves over time‰ and „tends to become a chronic problem‰. The literature tends to support the latter of these rather than the former. A prospective longitudinal study found that 94% of 63 adolescent females had ongoing pain two to four years after initial presentation, while one in four had significant symptoms up to 20 years later[9]. Cross- sectional studies report mean patellofemoral pain durations of 43 months (range 6 to 108) [10] and 8 years (range 1 to 25). The median duration of knee pain of our RCT cohort reflected this chronic tendency (28 months (interquartile range 12 to 84))[2]. Our finding that individuals with patellofemoral pain have considerable symptom duration suggests that the condition does not spontaneously resolve
5. There are a few minor points that we feel should be further clarified for the reader:
(a) The study by Wiener-Ogilvie & Jones [11] was a pilot trial that was substantially underpowered to detect any between-group differences. Hence, to summarise their data as evidence of no effect is problematic as there is a high likelihood of a type II error (that is, accepting that there is no effect when in truth/fact there is an effect).
(b) The editorial makes a summarising statement that our trial confirms the good results of exercises and orthoses in the short term and cites Crossley et al[12], presumably in support of that statement. It is erroneous to do such, as Crossley and colleagues evaluated a multi-modal physiotherapy treatment that included exercise and tape, but not foot orthoses. Our study was the first adequately powered, high quality RCT to provide point estimates of effect that favoured orthoses over flat inserts in the short term.
(c) We note a reference to orthoses being used without prescription in the opening paragraph that may be misinterpreted by the reader as to mean that the orthoses used were applied by a lay person, possibly bought across the counter of a retail outlet. This would be misleading as we used qualified physiotherapists who received additional training to fit and modify the orthoses following a predetermined algorithm (see [13 ,14] for more information). In brief, the orthoses were prescribed on the basis of fit and comfort in the first instance and then modified to improve pain- free performance of a previously painful task. We propose that fitting of orthoses in this way is likely best performed by a physiotherapist, podiatrist or athletic trainer, but medical practitioners with a predilection to using physical therapies should also be able to effectively fit orthoses.
(d) The authors cite a recent systematic review that they state found no evidence to support the use of any orthotic devices in patellofemoral pain[15]. This conclusion is misleading, as all five included studies evaluated knee orthotic devices, not foot orthoses. We performed a systematic review and meta-analysis[16] of more recent publications, which identified two small RCTs for foot orthoses in patellofemoral pain, one of which was underpowered to detect between-group differences [11]. Although the other study did not provide point estimates of effect for calculation of effect sizes, the authors reported a significantly greater reduction in patellofemoral pain in those treated with foot orthoses than the group that received flat inserts [17]. This study was not included in the review by D‚Hondt et al[15] due to a lack of statistical data.
Re: Foot orthoses and patellofemoral pain syndrome
Quote:
Originally Posted by Admin
Editorial
Patellofemoral pain syndrome
Usually resolves over time, and intervention offers only limited benefit
I just love the researchers that use this line as a defense for not treating pathologies. What do you tell the 16 year old female runner that develops patellofemoral pain syndrome while eagerly training with her cross-country team and desires to continue her training and improve her times? Sorry Sally, none of the treatments are 100% and your pain will resolve over time (yeah, once you stop running it will resolve and will come back again once you start running!!)
Sounds to me like another excuse for governmments with socialized medicine and health maintenance organizations to have a reason to not treat pathologies that are easily treatable by experienced and skilled clinicians.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
Re: Foot orthoses and patellofemoral pain syndrome
Quote:
I just love the researchers that use this line as a defense for not treating pathologies. What do you tell the 16 year old female runner that develops patellofemoral pain syndrome while eagerly training with her cross-country team and desires to continue her training and improve her times? Sorry Sally, none of the treatments are 100% and your pain will resolve over time (yeah, once you stop running it will resolve and will come back again once you start running!!)
Yep- 100% agree.
This approach would not make good business sense- not because you don't treat them and therefore don't charge them, but because you wouldn't get much in the way of 'word of mouth' referalls. Patient satisfaction would be pretty poor.
They come to you because they are in pain and want help....
I don't think that I would be visiting either C Niek van Dijk or Willem M van der Tempel if I had PFJ pain...
With respect to the study- I am somewhat surprised that there was no apparent combined effect with Physio and the OTC orthos. I feel these are usually very complementry.
__________________
Craig Tanner
Podiatrist ASPETAR-
Qatar Orthopaedic and Sports Medicine Hospital
Doha
QATAR http://www.aspetar.com/
Last edited by CraigT : 1st November 2008 at 11:31 PM.
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Foot orthoses and patellofemoral pain syndrome
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