Dataset Information

Orthosis-Shaped Sandals Are as Efficacious as In-Shoe Orthoses and Better than Flat Sandals for Plantar Heel Pain: A Randomized Control Trial.

ABSTRACT: 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.

SUBMITTER: Vicenzino B

PROVIDER: S-EPMC4686010 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Orthosis-Shaped Sandals Are as Efficacious as In-Shoe Orthoses and Better than Flat Sandals for Plantar Heel Pain: A Randomized Control Trial.

Vicenzino Bill B McPoil Thomas G TG Stephenson Aoife A Paul Sanjoy K SK

PloS one 20151215 12

<h4>Objective</h4>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.<h4>Method</h4>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 ov ...[more]

PMID: 26669302

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Project description:Background Foot orthoses and corticosteroid injection are common interventions used for plantar heel pain, however few studies have investigated the variables that predict response to these interventions. Methods Baseline variables (age, weight, height, body mass index (BMI), sex, education, foot pain, foot function, fear-avoidance beliefs and feelings, foot posture, weightbearing ankle dorsiflexion, plantar fascia thickness, and treatment preference) from a randomised trial in which participants received either foot orthoses or corticosteroid injection were used to predict change in the Foot Health Status Questionnaire foot pain and foot function subscales, and first-step pain measured using a visual analogue scale. Multivariable linear regression models were generated for different dependent variables (i.e. foot pain, foot function and first-step pain), for each intervention (i.e. foot orthoses and corticosteroid injection), and at different timepoints (i.e. weeks 4 and 12). Results For foot orthoses at week 4, greater ankle dorsiflexion with the knee extended predicted reduction in foot pain (adjusted R2?=?0.16, p?=?0.034), and lower fear-avoidance beliefs and feelings predicted improvement in foot function (adjusted R2?=?0.43, p?=?0.001). At week 12, lower BMI predicted reduction in foot pain (adjusted R2?=?0.33, p?<?0.001), improvement in foot function (adjusted R2?=?0.37, p?<?0.001) and reduction in first-step pain (adjusted R2 0.19, p?=?0.011). For corticosteroid injection at week 4, there were no significant predictors for change in foot pain or foot function. At week 12, less weightbearing hours predicted reduction in foot pain (adjusted R2?=?0.25, p?=?0.004) and lower baseline foot pain predicted improvement in foot function (adjusted R2?=?0.38, p?<?0.001). Conclusions People with plantar heel pain who use foot orthoses experience reduced foot pain if they have greater ankle dorsiflexion and lower BMI, while they experience improved foot function if they have lower fear-avoidance beliefs and lower BMI. People who receive a corticosteroid injection experience reduced foot pain if they weightbear for fewer hours, while they experience improved foot function if they have less baseline foot pain.

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.

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 .

Project description:BackgroundMedical imaging can be used to assist with the diagnosis of plantar heel pain. The aim of this study was to synthesise medical imaging features associated with plantar heel pain.MethodsThis systematic review and meta-analysis conducted searches in MEDLINE, CINAHL, SPORTDiscus, Embase and the Cochrane Library from inception to 12th February 2021. Peer-reviewed articles of cross-sectional observational studies written in English that compared medical imaging findings in adult participants with plantar heel pain to control participants without plantar heel pain were included. Study quality and risk of bias was assessed using the National Institutes of Health quality assessment tool for observational cohort and cross-sectional studies. Sensitivity analyses were conducted where appropriate to account for studies that used unblinded assessors.ResultsForty-two studies (2928 participants) were identified and included in analyses. Only 21% of studies were rated 'good' on quality assessment. Imaging features associated with plantar heel pain included a thickened plantar fascia (on ultrasound and MRI), abnormalities of the plantar fascia (on ultrasound and MRI), abnormalities of adjacent tissue such as a thickened loaded plantar heel fat pad (on ultrasound), and a plantar calcaneal spur (on x-ray). In addition, there is some evidence from more than one study that there is increased hyperaemia within the fascia (on power Doppler ultrasound) and abnormalities of bone in the calcaneus (increased uptake on technetium-99 m bone scan and bone marrow oedema on MRI).ConclusionsPeople with plantar heel pain are more likely to have a thickened plantar fascia, abnormal plantar fascia tissue, a thicker loaded plantar heel fat pad, and a plantar calcaneal spur. In addition, there is some evidence of hyperaemia within the plantar fascia and abnormalities of the calcaneus. Whilst these medical imaging features may aid with diagnosis, additional high-quality studies investigating medical imaging findings for some of these imaging features would be worthwhile to improve the precision of these findings and determine their clinical relevance.

Project description:BACKGROUND:Plantar heel pain is a common source of pain and disability. Evidence-based treatment decisions for people with plantar heel pain should be guided by the best available evidence, expert clinical reasoning, and consider the needs of the patient. Education is a key component of care for any patient and needs to be tailored to the patient and their condition. However, no previous work has identified, far less evaluated, the approaches and content required for optimal education for people with plantar heel pain. The aim of this study was to gather the patients' perspective regarding their lived experience, attitudes and educational needs in order to inform the content and provision of meaningful education delivery approaches. METHODS:Using a qualitative descriptive design, semi-structured interviews were conducted with participants with a clinical diagnosis of plantar heel pain. A topic guide was utilised that focused on the experience of living with plantar heel pain and attitudes regarding treatment and educational needs. Interviews were audio recorded, transcribed verbatim and analysed using the Framework approach. Each transcription, and the initial findings, were reported back to participants to invite respondent validation. RESULTS:Eighteen people with plantar heel pain were interviewed. Descriptive analysis revealed eight themes including perceptions of plantar heel pain, impact on self, dealing with plantar heel pain, source of information, patient needs, patient unmet needs, advice to others and interest in online education. Participants revealed doubt about the cause, treatment and prognosis of plantar heel pain. They also expressed a desire to have their pain eliminated and education individually tailored to their condition and needs. Respondent validation revealed that the transcripts were accurate, and participants were able to recognise their own experiences in the synthesised themes. CONCLUSION:Plantar heel pain has a negative impact on health-related quality of life. Participants wanted their pain eliminated and reported that their expectations and needs were frequently unmet. Health professionals have an important role to be responsive to the needs of the patient to improve their knowledge and influence pain and behaviour. Our study informs the content needed to help educate people with plantar heel pain.

Project description:OBJECTIVES:To compare the effectiveness of dry needling (DN) versus percutaneous needle electrolysis (PNE) for improving the level of pain, function and quality of life (QoL) of patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points. DESIGN:A prospective, parallel-group, randomised controlled trial with blinded outcome assessment. SETTING:A single treatment facility in the State of Kuwait. PARTICIPANTS:118 participants were screened for eligibility. Of these, 102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial. INTERVENTIONS:Two parallel groups, one study arm received DN and a stretching protocol whereas the other arm received percutaneous needling electrolysis with a stretching protocol. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcome measure was the Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains. Secondary outcome measures included the 0-10 numerical rating scale pain visual analogue scale (VAS) scores, performed before and after each treatment session. In addition, QoL was measured using the EuroQoL-5 dimensions. All measurements were taken at baseline, at 4, 8, 12, 26 and 52 weeks. RESULTS:Foot Pain domain improved at all time points for DN group (p<0.001; 29.7 (17.8 to 41.5)) and percutaneous needling electrolysis group (p<0.001; 32.7 (18.3 to 47.0)), without significant differences between groups. Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6 (-4.0 to -1.2)) and percutaneous needling electrolysis group (p<0.001; -3.0 (-4.5 to -1.6)). QoL improved at 4 weeks for both DN (p<0.01; 0.15 (0.5 to 0.25)) and percutaneous needling electrolysis group (p<0.01; 0.09 (0.01 to 0.17)) and at 8 and 52 weeks for the PNE group (p<0.01; 0.10 (0.02 to 0.18)), with significant differences between groups for the QoL at 52 weeks (p<0.05; 0.10 (0.01 to 0.18)). There were two small haematomas in the PNE group and one in the DN group. No serious adverse events were reported. CONCLUSIONS:Both PNE and DN were effective for PHP management, reducing mean and maximum pain since the first treatment session, with long lasting effects (52 weeks) and significant differences between groups in the case of QoL at 52 weeks in favour of the PNE group. TRIAL REGISTRATION NUMBER:NCT03236779.

Dataset Information

Orthosis-Shaped Sandals Are as Efficacious as In-Shoe Orthoses and Better than Flat Sandals for Plantar Heel Pain: A Randomized Control Trial.

Publications

Orthosis-Shaped Sandals Are as Efficacious as In-Shoe Orthoses and Better than Flat Sandals for Plantar Heel Pain: A Randomized Control Trial.

Similar Datasets

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