|Effectiveness of foot orthoses for treatment and prevention of lower limb injuries: a review
|Hume P, Hopkins W, Rome K, Maulder P, Coyle G, Nigg B
The review aimed to determine the clinical effects of foot orthoses (FOs) for the treatment and prevention of plantar fasciitis, tibial stress fractures and patellofemoral pain syndrome. Given the paucity of the evidence, the authors appropriately stated that further research is required.
To determine the clinical effects of foot orthoses (FOs) for the treatment and prevention of plantar fasciitis, tibial stress fractures and patellofemoral pain syndrome.
AMED, CINAHL, MEDLINE, and SPORTDiscus were searched up to March 2008 for relevant papers published in English. Search terms were reported. Reference lists of relevant papers were also checked.
Randomised controlled trials (RCTs), controlled clinical studies, and uncontrolled clinical studies of FOs used for the treatment or prevention of plantar fasciitis, patellofemoral pain or tibial stress fractures were eligible for inclusion in the review. A chronic condition with a relatively short treatment duration compared with the prior duration of the injury was required. Studies with co-interventions were excluded if the effect of the co-intervention was not clear.
A number of different types of FOs were included in the review, these were categorised into customised, prefabricated rigid, semi-rigid, or soft. People with plantar fasciitis, proximal plantar fasciitis, plantar heel pain, heel pain, patellofemoral pain and mixed populations were included in the review. Prior duration of injury ranged from one month to 96 months. Outcomes of interest included pain, comfort, function and injury status. A number of different outcome measures were included in the review: foot pain, foot health status questionnaire (FHSQ including subcategories of footwear, foot pain and foot function), general foot health (GFH), pain during day, pain first step, treatment success, low pain, perceived improvement, positive final assessment, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC including subcategories pain, stiffness and function), foot disability index (FDI), walking pain, walk time (100m) and proportion still using FOs.
Papers were initially selected by one reviewer, followed with evaluation by two additional reviewers to confirm inclusion in the review. Selection from an updated search was carried out independently by two reviewers.
Assessment of study quality
The authors provided a overall summary of study quality but they did not state that they systematically assessed the validity of the included studies.
Differences, changes or differences between changes in the means of continuous measures were calculated as standardised effects for each study. Magnitude of effect size was interpreted using a modified version of Cohen's scale (<0.20, trivial; 0.20 to 0.59, small; 0.60 to 1.19, moderate; ≥1.20, large). Where possible, hazard ratios (HR) and their corresponding confidence limits were calculated for each study for outcomes representing counts or proportions of injury (details of approach used reported in the paper). The magnitude of the HR was interpreted using the following scale: <1.28, trivial; 1.28 to 1.99, small; 2.0 to 4.4, moderate; ≥4.5, large). An effect was considered 'unclear' if its confidence intervals overlapped the thresholds for substantiveness (i.e. the likelihood of effect being either substantially positive or negative was >5%).
The authors did not state how data were extracted or how many reviewers performed the data extraction.
Methods of synthesis
Studies were combined in a narrative synthesis, grouped by outcome (treatment/prevention), study design (controlled/uncontrolled) or population (plantar fasciitis, patellofemoral pain or tibial stress fractures).
Results of the review
Seventeen studies were included in the review (n=unclear); 11 controlled studies and six uncontrolled studies.
Effectiveness of FO in the treatment of chronic lower limb pain:
Controlled studies (six studies): Two studies provided sufficient information to calculate standardised effect sizes. In one study (n=180) prefabricated semi-rigid FOs demonstrated a moderately beneficial short-term (up to 12 months) effect compared with customised soft sham FOs for the treatment of foot pain and foot function for plantar fasciitis. Another study (n=48) demonstrated a small harmful effect of prefabricated semi-rigid FOs compared with prefabricated soft FOs for treating injuries (as measured by the FHSQ and GFH) for plantar heel pain. Two studies provided sufficient information to calculate HRs. A moderate benefit of FOs (semi-rigid versus anti-inflammatories and prefabricated soft (silicone) versus stretch) was found in two studies (one study each) for plantar fasciitis. One study found small to moderate harm for prefabricated soft versus anti-inflammatories for treatment success and low pain in plantar fasciitis. The magnitude of effect was unclear in one study. Three studies reported benefits of FOs in reducing the prevalence of injury. None of the studies found an beneficial effect of FO for preventing chronic lower limb (as assessed by a proportion of injuries where the control group was mechanical).
Uncontrolled studies (six studies): All FOs (customised rigid, customised semi-rigid, and customised soft) demonstrated at least a moderate benefit on all but one outcome (100m walk time) for plantar fasciitis and patellofemoral pain.
Effectiveness of FO in preventing chronic lower limb pain:
Controlled studies (six studies): Of five military studies, in which the control group did not have mechanical intervention, two studies demonstrated a moderate or large effect of FOs in preventing injuries for posterior tibial stress fractures, using a variety of FOs. In two studies in which the control group had a mechanical intervention: one study found a moderate benefit of customised semi-rigid and customised soft FOs compared with insoles in increasing comfort for army recruits; the other study found a trivial benefit of customised semi-rigid and prefabricated semi-rigid, but a small harm of prefabricated soft compared to customised soft FOs for increased comfort.
Customised semi-rigid FOs have moderate to large benefits in treating plantar fasciitis, moderate effects in preventing posterior tibial stress fractures, and small to moderate effects in treating or preventing patellofemoral pain syndrome. Prefabricated semi-rigid FOs have moderate benefits in treating foot pain and foot function. However, further research with RCTs is needed in order to establish the clinical use of specific types of FOs for the treatment and prevention of various lower limb injuries.
The review question was supported by clear inclusion criteria in terms of study design, population and intervention. Several databases were searched, although this search was restricted by language (English publications) and might mean that relevant studies were not included in the review. Methods used to select studies appear to minimise the likelihood of reviewer error and bias but the authors did not state whether similar methods were used to extract data from the included studies. The authors did not state that they assessed the validity of the included studies making it more difficult to interpret the given results. A narrative synthesis was appropriate given the differences between the included studies in terms of intervention and population. The authors highlighted that the outcomes taken from military studies cannot be generalised to the general sports population. Given the paucity of the evidence, the authors appropriately stated that further research is required.
Implications of the review for practice and research
Practice: The authors suggested that healthcare professional should administer FOs with a specific functional kinematic, kinetic and/or muscle activity in mind.
Research: The authors stated that further research with RCTs is required in order to establish the clinical use of specific types of FO for treatment and prevention of various lower limb injuries. Future studies should include functional outcome analysis. Further epidemiological, biomechanical and clinical studies should look at the evidence of FOs for: re-establishing normal lower extremity biomechanics; improving lower extremity alignment; controlling subtalar joint movement and excessive pronation; changing lower extremity kinematics; attenuating the forces of weight bearing; and reducing lower extremity shock. Further research on different sporting groups is needed, particularly in long distance runners. A further recommendation was made for an international consensus relating to FO definition.
New Zealand Accident Compensation Corporation.
Hume P, Hopkins W, Rome K, Maulder P, Coyle G, Nigg B. Effectiveness of foot orthoses for treatment and prevention of lower limb injuries: a review. Sports Medicine 2008; 38(9): 759-779
Subject indexing assigned by NLM
Foot; Humans; Lower Extremity /injuries; Orthotic Devices; Treatment Outcome; Wounds and Injuries /prevention & control
Date bibliographic record published
Date abstract record published
This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.