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Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.

ABSTRACT: BACKGROUND:Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP. METHODS:Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12?weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance. DISCUSSION:To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT. TRIAL REGISTRATION:The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.

SUBMITTER: Franettovich Smith MM

PROVIDER: S-EPMC7206811 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.

Franettovich Smith Melinda M MM Collins Natalie J NJ Mellor Rebecca R Grimaldi Alison A Elliott James J Hoggarth Mark M Weber Ii Kenneth A KA Vicenzino Bill B

Journal of foot and ankle research 20200508 1

<h4>Background</h4>Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot f ...[more]

PMID: 32384905

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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: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.

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:OBJECTIVE:To compare the effects of a programme of load management education plus exercise, corticosteroid injection use, and no treatment on pain and global improvement in individuals with gluteal tendinopathy. DESIGN:Prospective, three arm, single blinded, randomised clinical trial. SETTING:Brisbane and Melbourne, Australia. PARTICIPANTS:Individuals aged 35-70 years, with lateral hip pain for more than three months, at least 4/10 on the pain numerical rating scale, and gluteal tendinopathy confirmed by clinical diagnosis and magnetic resonance imaging; and with no corticosteroid injection use in previous 12 months, current physiotherapy, total hip replacement, or neurological conditions. INTERVENTIONS:A physiotherapy led education and exercise programme of 14 sessions over eight weeks (EDX; n=69), one corticosteroid injection (CSI; n=66), and a wait and see approach (WS; n=69). MAIN OUTCOMES:Primary outcomes were patient reported global rating of change in hip condition (on an 11 point scale, dichotomised to success and non-success) and pain intensity in the past week (0=no pain, 10=worst pain) at eight weeks, with longer term follow-up at 52 weeks. RESULTS:Of 204 randomised participants (including 167 women; mean age 54.8 years (standard deviation 8.8)), 189 (92.6%) completed 52 week follow-up. Success on the global rating of change was reported at eight weeks by 51/66 EDX, 38/65 CSI, and 20/68 WS participants. EDX and CSI had better global improvement scores than WS (risk difference 49.1% (95% confidence interval 34.6% to 63.5%), number needed to treat 2.0 (95% confidence interval 1.6 to 2.9); 29.2% (13.2% to 45.2%), 3.4 (2.2 to 7.6); respectively). EDX had better global improvement scores than CSI (19.9% (4.7% to 35.0%); 5.0 (2.9 to 21.1)). At eight weeks, reported pain on the numerical rating scale was mean score 1.5 (standard deviation 1.5) for EDX, 2.7 (2.4) for CSI, and 3.8 (2.0) for WS. EDX and CSI participants reported less pain than WS (mean difference -2.2 (95% confidence interval -2.89 to -1.54); -1.2 (-1.85 to -0.50); respectively), and EDX participants reported less pain than CSI (-1.04 (-1.72 to -0.37)). Success on the global rating of change was reported at 52 weeks by 51/65 EDX, 36/63 CSI, and 31/60 WS participants; EDX was better than CSI (20.4% (4.9% to 35.9%); 4.9 (2.8 to 20.6)) and WS (26.8% (11.3% to 42.3%); 3.7 (2.4 to 8.8)). Reported pain at 52 weeks was 2.1 (2.2) for EDX, 2.3 (1.9) for CSI, and 3.2 (2.6) for WS; EDX did not differ from CSI (-0.26 (-1.06 to 0.55)), but both treatments did better than WS (1.13 (-1.93 to -0.33); 0.87 (-1.68 to -0.07); respectively). CONCLUSIONS:For gluteal tendinopathy, education plus exercise and corticosteroid injection use resulted in higher rates of patient reported global improvement and lower pain intensity than no treatment at eight weeks. Education plus exercise performed better than corticosteroid injection use. At 52 week follow-up, education plus exercise led to better global improvement than corticosteroid injection use, but no difference in pain intensity. These results support EDX as an effective management approach for gluteal tendinopathy. TRIAL REGISTRATION:Prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN12612001126808).

Project description:BackgroundPlantar heel pain (PHP) accounts for 11-15% of foot symptoms requiring professional care in adults. Recovery is variable, with no robust prognostic guides for sufferers, clinicians or researchers. Therefore, we aimed to determine the validity, reliability and feasibility of questionnaire, clinical and biomechanical measures selected to generate a prognostic model in a subsequent cohort study.MethodsThirty-six people (19 females & 17 males; 20-63 years) were recruited with equal numbers in each of three groups: people with PHP (PwPHP), other foot pain (PwOP) and healthy (H) controls. Eighteen people performed a questionnaire battery twice in a randomised order to determine online and face-to-face agreement. The remaining 18 completed the online questionnaire once, plus clinical measurements including strength and range of motion, mid-foot mobility, palpation and ultrasound assessment of plantar fascia. Nine of the same people underwent biomechanical assessment in the form of a graded loaded challenge augmenting walking with added external weight and amended step length on two occasions. Outcome measures were (1) feasibility of the data collection procedure, measurement time and other feedback; (2) establishing equivalence to usual procedures for the questionnaire battery; known-group validity for clinical and imaging measures; and initial validation and reliability of biomechanical measures.ResultsThere were no systematic differences between online and face-to-face administration of questionnaires (p-values all > .05) nor an administration order effect (d = - 0.31-0.25). Questionnaire reliability was good or excellent (ICC2,1_absolute)(ICC 0.86-0.99), except for two subscales. Full completion of the survey took 29 ± 14 min. Clinically, PwPHP had significantly less ankle-dorsiflexion and hip internal-rotation compared to healthy controls [mean (±SD) for PwPHP-PwOP-H = 14°(±6)-18°(±8)-28°(±10); 43°(±4)- 45°(±9)-57°(±12) respectively; p < .02 for both]. Plantar fascia thickness was significantly higher in PwPHP (3.6(0.4) mm vs 2.9(0.4) mm, p = .01) than the other groups. The graded loading challenge demonstrated progressively increasing ground reaction forces.ConclusionOnline questionnaire administration was valid therefore facilitating large cohort recruitment and being relevant to remote service evaluation and research. The physical and ultrasound examination revealed the expected differences between groups, while the graded loaded challenge progressively increases load and warrants future research. Clinician and researchers can be confident about these methodological approaches and the cohort study, from which useful clinical tools should result, is feasible.Level of evidenceIV.

Dataset Information

Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.

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Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.

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