Predictors of response to foot orthoses and corticosteroid injection for plantar heel pain
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ABSTRACT:
SUBMITTER: Whittaker G
PROVIDER: S-EPMC7526364 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundCorticosteroid injection is frequently used for plantar heel pain (plantar fasciitis), although there is limited high-quality evidence to support this treatment. Therefore, this study reviewed randomised trials to estimate the effectiveness of corticosteroid injection for plantar heel pain.MethodsA systematic review and meta-analysis of randomised trials that compared corticosteroid injection to any comparator. Primary outcomes were pain and function, categorised as short (0 to 6?weeks), medium (7 to 12?weeks) or longer term (13 to 52?weeks).ResultsA total of 47 trials (2989 participants) were included. For reducing pain in the short term, corticosteroid injection was more effective than autologous blood injection (SMD -0.56; 95% CI, -?0.86 to -?0.26) and foot orthoses (SMD -0.91; 95% CI, -?1.69 to -?0.13). There were no significant findings in the medium term. In the longer term, corticosteroid injection was less effective than dry needling (SMD 1.45; 95% CI, 0.70 to 2.19) and platelet-rich plasma injection (SMD 0.61; 95% CI, 0.16 to 1.06). Notably, corticosteroid injection was found to have similar effectiveness to placebo injection for reducing pain in the short (SMD -0.98; 95% CI, -?2.06, 0.11) and medium terms (SMD -0.86; 95% CI, -?1.90 to 0.19). For improving function, corticosteroid injection was more effective than physical therapy in the short term (SMD -0.69; 95% CI, -?1.31 to -?0.07). When trials considered to have high risk of bias were excluded, there were no significant findings.ConclusionsBased on the findings of this review, corticosteroid injection is more effective than some comparators for the reduction of pain and the improvement of function in people with plantar heel pain. However, corticosteroid injection is not more effective than placebo injection for reducing pain or improving function. Further trials that are of low risk of bias will strengthen this evidence.RegistrationPROSPERO registration number CRD42016053216 .
| S-EPMC6698340 | biostudies-literature
Project description:BackgroundPlantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP.MethodsThis was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation.ResultsEighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64-100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5-0.6, 0.4 and < 0.3, respectively.ConclusionsWe demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP.Trial registration numberISRCTN 12160508 . Prospectively registered 5th July 2016.
| S-EPMC8015033 | biostudies-literature
Project description:BackgroundFoot orthoses have been demonstrated to be effective in the management of a range of conditions, but there is debate as to the benefits of customised foot orthoses over less expensive, prefabricated devices.MethodsIn a randomised, cross-over trial, 15 flat-footed participants aged between 18 and 45 years were provided with semi-rigid, customised orthoses and semi-rigid, contoured, prefabricated orthoses. Pressures and forces were measured using an in-shoe system with subjects wearing shoes alone, wearing customised orthoses, and again when wearing contoured prefabricated orthoses. Two weeks acclimatisation was included between cross-over of therapy. Repeated measures ANOVA models with post-hoc, pair-wise comparisons were used to test for differences.ResultsWhen compared to wearing shoes alone, wearing either the customised orthoses or the prefabricated orthoses was associated with increases in force and force time integrals in the midfoot region. Peak and maximum mean pressure and pressure-time, and force-time integrals were reduced in both the medial and lateral forefoot. There were, however, no significant differences between the customised orthoses and the prefabricated orthoses at any site.ConclusionThere was a similar change in loading with both the semi-rigid customised and the semi-rigid prefabricated orthoses when compared to the shoe alone condition. However, while customised devices offered minor differences over prefabricated orthoses in some variables, these were not statistically significant. The results suggest that there may be only minor differences in the effects on plantar pressures between the customised and the less expensive prefabricated orthoses tested in this study, however further research is warranted.
| S-EPMC2711934 | biostudies-literature
Project description:BackgroundThe effectiveness of foot orthoses has been evaluated in many clinical trials with sham foot orthoses used as the control intervention in at least 10 clinical trials. However, the mechanical effects and credibility of sham orthoses has been rarely quantified. This study aimed to: (i) compare the effects on plantar pressures of three sham foot orthoses to a customised foot orthosis, and (ii) establish the perceived credibility and the expected benefit of each orthotic condition.MethodsThirty adults aged between 18 and 51 participated in this study. At 0 and 4 weeks, plantar pressure data were collected for the heel, midfoot and forefoot using the pedar(®)-X in-shoe system for the following five randomly assigned conditions: (i) shoe alone, (ii) customised foot orthosis, (iii) contoured polyethylene sham foot orthosis, (iv) contoured EVA sham foot orthosis, and (v) flat EVA sham foot orthosis. At the initial data collection session, each participant completed a Credibility/Expectancy Questionnaire (CEQ) to determine the credibility and expected benefit of each orthotic condition.ResultsCompared to the shoe alone at week 0, the contoured polyethylene sham orthosis was the only condition to not significantly effect peak pressure at any region of the foot. In contrast, the contoured EVA sham orthosis, the flat EVA sham orthosis and the customised orthosis significantly reduced peak pressure at the heel. At the medial midfoot, all sham orthoses provided the same effect as the shoe alone, which corresponded to effects that were significantly different to the customised orthosis. There were no differences in peak pressure between conditions at the other mask regions, the lateral midfoot and forefoot. When the conditions were compared at week 4, the differences between the conditions were generally similar to the findings observed at week 0. With respect to credibility and expected benefit, all orthotic conditions were considered the same with the exception of the contoured polyethylene sham orthosis, which was perceived as being less credible and less likely to provide benefits.ConclusionThe findings of this study indicate that all of the sham orthoses tested provided the same effect on plantar pressures at the midfoot and forefoot as a shoe alone. However, the contoured EVA sham orthosis and the flat EVA sham orthosis significantly reduced peak pressure under the heel, which was similar to the customised orthosis. In contrast, the contoured polyethylene sham orthosis had no significant effect on plantar pressure and was comparable to the shoe alone at all regions of the foot. Hence, lower plantar pressures were found under the heel with some sham orthoses, but not with others. Importantly, participants perceived the polyethylene sham orthosis - the sham that had no effect on plantar pressure - to be the least credible orthosis and the least likely to provide benefits. This may be critical for the design of future clinical trials as it may introduce confounding effects that produce inaccurate results. These findings provide some evidence for the mechanical effects, treatment credibility and expected benefit of sham foot orthoses, which should be considered when they are used as a control intervention in a clinical trial.
| S-EPMC3663766 | biostudies-literature
Project description:BackgroundFoot orthoses are routinely used to treat plantar fasciopathy in clinical practice. However, minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. This study investigated the effect of wearing custom foot orthoses and new athletic footwear on first-step pain, average 24-h pain and plantar fascia thickness in people with unilateral plantar fasciopathy over 12 weeks.MethodsA parallel, three-arm randomised controlled trial with blinding of participants and assessors. 60 participants diagnosed with unilateral plantar fasciopathy were randomised to either custom foot orthoses and new shoes (orthoses group), a sham insole with a new shoes (shoe group) or a sham insole placed in the participant's regular shoes (control group). Primary outcome was first-step pain. Secondary outcomes were average 24-h pain and plantar fascia thickness measured on ultrasound. Outcomes were assessed at baseline, 4 week and 12 week trial time-points.ResultsAt 4 weeks, the orthoses group reported less first-step pain (p = 0.002) compared to the control group. At 12 weeks, the orthoses group reported less first-step pain compared to both the shoe (p = < 0.001) and sham (p = 0.01) groups. Both the orthoses (p = < 0.001) and shoe (p = 0.006) groups reported less average 24-h pain compared to the control group at 4 and 12 weeks. The orthoses group demonstrated reduced plantar fascia thickness on ultrasound compared to both the shoe (p = 0.032) and control groups (p = 0.011).ConclusionsCustom foot orthoses in new shoes improve first-step pain and reduce plantar fascia thickness over a period of 12 weeks compared to new shoes alone or a sham intervention.Trial registrationAustralian New Zealand Clinical Trials Registry ( ACTRN 12613000446763 ). Submitted on the 10th of April 2013 and registered on the 18th of April 2013.
| S-EPMC6052580 | biostudies-literature
Project description:ObjectivesTo examine associations between plantar calcaneal spurs, plantar fascia thickening and plantar heel pain (PHP), and to determine whether tenderness on palpation of the heel differentiates between these presentations.MethodsAdults aged ⩾50 years registered with four general practices were mailed a Health Survey. Responders reporting foot pain within the last 12 months underwent a detailed clinical assessment. PHP in the past month was documented using a foot manikin. Plantar calcaneal spurs were identified from weight-bearing lateral radiographs and plantar fascia thickening (defined as >4 mm) from ultrasound. Tenderness on palpation of the plantar fascia insertion was documented. Associations between these factors and PHP were explored using generalized estimating equations.ResultsClinical and radiographic data were available from 530 participants (296 women, mean [s.d.] age 64.9 [8.4] years), 117 (22.1%) of whom reported PHP. Plantar calcaneal spurs and plantar fascia thickening were identified in 281 (26.5%) and 501 (47.3%) feet, respectively, but frequently coexisted (n = 217, 20.4%). Isolated plantar calcaneal spurs were rare (n = 64, 6.0%). Participants with PHP were more likely to have a combination of these features compared with those without PHP (odds ratio 2.16, 95% CI 1.24, 3.77, P = 0.007). Tenderness on palpation of the heel was not associated with plantar calcaneal spurs or plantar fascia thickening, either in isolation or in combination, in those with PHP.ConclusionPlantar calcaneal spurs and plantar fascial thickening are associated with PHP, but frequently coexist. Tenderness on palpation of the heel does not appear to differentiate between clinical presentations of PHP.
| S-EPMC6519610 | biostudies-literature
Project description: Not available
| S-EPMC6481652 | biostudies-literature
Project description:BACKGROUND:Plantar fasciopathy has a lifetime prevalence of 10%. Patients experience sharp pain under the heel, often for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. A corticosteroid injection offers short-term pain relief but is no better than placebo in the longer term (>?8?weeks). Heavy-slow resistance training has shown potentially positive effects on long-term outcomes (>?3?months), and combining exercises with an injection may prove to be superior to exercises alone. However, the effect of heavy-slow resistance training compared with a simpler approach of patient advice (e.g., load management) and insoles is currently unknown. This trial compares the efficacy of patient advice with patient advice plus heavy-slow resistance training and with patient advice plus heavy-slow resistance training plus a corticosteroid injection in improving the Foot Health Status Questionnaire pain score after 12?weeks in patients with plantar fasciopathy. METHODS:In this randomised superiority trial, we will recruit 180 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of three groups: (1) patient advice and an insole (n?=?60); (2) patient advice, an insole, and self-dosed heavy-slow resistance training consisting of heel raises (n?=?60); or (3) patient advice, an insole, heavy-slow resistance training, and an ultrasound-guided corticosteroid injection (n?=?60). All participants will be followed for 1 year, with the 12-week follow-up considered the primary endpoint. The primary outcome is the Foot Health Status questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a 7-point Global Rating of Change, the Pain Self-Efficacy Questionnaire, physical activity level, health-related quality of life measured by the EQ-5D-5L, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment. Additionally, a health economic evaluation of the treatments will be carried out. DISCUSSION:This trial will test if adding heavy-slow resistance training to fundamental patient advice and an insole improves outcomes and if a corticosteroid injection adds even further to that effect in patients with plantar fasciopathy. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03804008. Prospectively registered on January 15, 2019.
| S-EPMC6941397 | biostudies-literature
Project description:OBJECTIVE:To investigate efficacy of a contoured sandal being marketed for plantar heel pain with comparison to a flat flip-flop and contoured in-shoe insert/orthosis. METHOD:150 volunteers aged 50 (SD: 12) years with plantar heel pain (>4 weeks) were enrolled after responding to advertisements and eligibility determined by telephone and at first visit. Participants were randomly allocated to receive commercially available contoured sandals (n = 49), flat flip-flops (n = 50) or over the counter, pre-fabricated full-length foot orthotics (n = 51). Primary outcomes were a 15-point Global Rating of Change scale (GROC: 1 = a very great deal worse, 15 = a very great deal better), 13 to 15 representing an improvement and the 20-item Lower Extremity Function Scale (LEFS) on which participants rate 20 common weight bearing activities and activities of daily living on a 5-point scale (0 = extreme difficulty, 4 = no difficulty). Secondary outcomes were worst level of heel pain in the preceding week, and the foot and ankle ability measure. Outcomes were collected blind to allocation. Analyses were done on an intention to treat basis with 12 weeks being the primary outcome time of interest. RESULTS:The contoured sandal was 68% more likely to report improvement in terms of GROC compared to flat flip-flop. On the LEFS the contoured sandal was 61% more likely than flat flip-flop to report improvement. The secondary outcomes in the main reflected the primary outcomes, and there were no differences between contoured sandal and shoe insert. CONCLUSIONS AND RELEVANCE:Physicians can have confidence in supporting a patient's decision to wear contoured sandals or in-shoe orthoses as one of the first and simple strategies to manage their heel pain. TRIAL REGISTRATION:The Australian New Zealand Clinical Trials Registry ACTRN12612000463875.
| S-EPMC4686010 | biostudies-literature
Project description:BACKGROUND: Plantar heel pain is a common foot disorder aggravated by weight-bearing activity. Despite considerable focus on therapeutic interventions such as orthoses, there has been limited investigation of footwear-related issues in people with plantar heel pain. The aim of this study was to investigate whether people with plantar heel pain experience footwear-related difficulties compared to asymptomatic individuals, as well as identifying factors associated with footwear comfort, fit and choice. METHODS: The footwear domain of the Foot Health Status Questionnaire (FHSQ) was assessed in 192 people with plantar heel pain and 69 asymptomatic controls. The plantar heel pain group was also assessed on a variety of measures including: foot posture, foot strength and flexibility, pedobarography and pain level. A univariate analysis of covariance, with age as the covariate, was used to compare the heel pain and control groups on the FHSQ footwear domain score. A multiple regression model was then constructed to investigate factors associated with footwear scores among participants with plantar heel pain. RESULTS: When compared to asymptomatic participants, people with plantar heel pain reported lower FHSQ footwear domain scores (mean difference -24.4; p?<?0.001; 95 % CI: -32.0 to -17.0). In the participants with heel pain, footwear scores were associated with maximum force beneath the postero-lateral heel during barefoot walking, toe flexor strength and gender. CONCLUSIONS: People with plantar heel pain experience difficulty with footwear comfort, fit and choice. Reduced heel loading during barefoot walking, toe flexor weakness and female gender are all independently associated with reports of footwear difficulties in people with heel pain. Increased focus, in both clinical and research settings, is needed to address footwear-related issues in people with plantar heel pain.
| S-EPMC4539852 | biostudies-literature