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Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial.

ABSTRACT: A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP.A parallel-group, block-randomized clinical trial will compare ePT and uPOD. Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy, exercise, and modalities, or podiatric care consisting primarily of a stretching handout, medication, injections, and orthotics. Treatment in each group will be directed by practice guidelines and a procedural manual, yet the specific intervention for each participant will be selected by the treating provider. Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator. In addition, differences in the European Quality of Life--Five Dimensions, Numeric Pain Rating Scale, Global Rating of Change (GROC), health-related costs, and cost-effectiveness at 6 weeks, 6 months, and 1 year will be compared between groups. The association between successful outcomes based on GROC score and participant expectations of recovery generally, and specific to physical therapy and podiatry treatment, will also be analyzed.This study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP. The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines.ClinicalTrials.gov: NCT01865734.

SUBMITTER: McClinton SM

PROVIDER: S-EPMC3866618 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial.

McClinton Shane M SM Flynn Timothy W TW Heiderscheit Bryan C BC McPoil Thomas G TG Pinto Daniel D Duffy Pamela A PA Bennett John D JD

Trials 20131203

<h4>Background</h4>A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective p ...[more]

PMID: 24299257

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Project description:BACKGROUND:Many patients will seek care from a podiatrist for plantar heel pain (PHP), while few of these patients will also be seen by a physical therapist. Physical therapists can provide treatment that is not a part of routine podiatric care for PHP and may provide additional improvement. Therefore, the purpose of this study was to examine the effects of interdisciplinary care for PHP that incorporated physical therapy treatment after initiating podiatric treatment. METHODS:Eligible individuals with PHP that presented to a podiatrist were randomized to receive usual podiatric care (uPOD) or usual podiatric care plus physical therapy treatment (uPOD+PT). The primary outcome was change in foot and ankle ability measure (FAAM) at 6-months. Secondary outcomes included change in numeric pain rating scale (NPRS), patient-reported success, and 6-week and 1-year endpoints. Patient-reported success was defined as the top two global rating of change scale rankings. Primary analysis was intention-to-treat (ITT) using analysis by covariance adjusted to baseline scores, and a secondary per-protocol (PP) analysis was performed analyzing only those who completed treatment. RESULTS:Ninety-five individuals participated and were included in the ITT analysis, and 79 were included in the PP analysis. For the primary outcome of FAAM change from baseline to 6-months, both groups improved significantly (uPOD+PT: 26.8 [95% CI 21.6, 31.9]; uPOD: (20 [15.6, 24.4]), but there was no between-group difference (4.3 [-?1, 9.6]). For secondary outcomes, the uPOD+PT group demonstrated greater improvement in NPRS at 6?weeks (0.9 [0.3, 1.4]) and 1?year (1.5 [0.6, 2.5]) in the ITT analysis. In the PP analysis, the uPOD+PT group demonstrated greater improvement in FAAM at 6?months (7.7 [2.1, 13.3]) and 1?year (5.5 [0.1, 10.8]), NPRS at 6?weeks (0.9 [0.2, 1.6]), 6?months (1.3 [0.6, 2.1]) and 1?year (1.3 [0.6, 2.1]), and in patient-reported success (relative risk [95% CI]) at 6?weeks (2.8 [1.1, 7.1]), 6?months (1.5 [1.1, 2.1]), and 1?year (1.5 [1.1, 1.9]). CONCLUSIONS:There was no significant benefit of uPOD+PT in the primary outcome of FAAM change at 6?months. Secondary outcomes and PP analysis indicated additional benefit of uPOD+PT, mostly observed in individuals who completed treatment. TRIAL REGISTRATION:Prospectively registered May 24, 2013 at www.clinicaltrials.gov (NCT01865734).

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 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: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.

Project description:BACKGROUND: Chronic plantar heel pain (CPHP) is a generalised term used to describe a range of undifferentiated conditions affecting the plantar heel. Plantar fasciitis is reported as the most common cause and the terms are frequently used interchangeably in the literature. Diagnostic imaging has been used by many researchers and practitioners to investigate the involvement of specific anatomical structures in CPHP. These observations help to explain the underlying pathology of the disorder, and are of benefit in forming an accurate diagnosis and targeted treatment plan. The purpose of this systematic review was to investigate the diagnostic imaging features associated with CPHP, and evaluate study findings by meta-analysis where appropriate. METHODS: Bibliographic databases including Medline, Embase, CINAHL, SportDiscus and The Cochrane Library were searched electronically on March 25, 2009. Eligible articles were required to report imaging findings in participants with CPHP unrelated to inflammatory arthritis, and to compare these findings with a control group. Methodological quality was evaluated by use of the Quality Index as described by Downs and Black. Meta-analysis of study data was conducted where appropriate. RESULTS: Plantar fascia thickness as measured by ultrasonography was the most widely reported imaging feature. Meta-analysis revealed that the plantar fascia of CPHP participants was 2.16 mm thicker than control participants (95% CI = 1.60 to 2.71 mm, P < 0.001) and that CPHP participants were more likely to have plantar fascia thickness values greater than 4.0 mm (OR = 105.11, 95% CI = 3.09 to 3577.28, P = 0.01). CPHP participants were also more likely to show radiographic evidence of subcalcaneal spur than control participants (OR = 8.52, 95% CI = 4.08 to 17.77, P < 0.001). CONCLUSION: This systematic review has identified 23 studies investigating the diagnostic imaging appearance of the plantar fascia and inferior calcaneum in people with CPHP. Analysis of these studies found that people with CPHP are likely to have a thickened plantar fascia with associated fluid collection, and that thickness values >4.0 mm are diagnostic of plantar fasciitis. Additionally, subcalcaneal spur formation is strongly associated with pain beneath the heel.

Dataset Information

Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial.

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Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial.

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