Dataset Information

Cost-effectiveness of custom-made insoles versus usual care in patients with plantar heel pain in primary care: cost-effectiveness analysis of a randomised controlled trial

ABSTRACT:

Objectives

To evaluate the cost-effectiveness of custom-made insoles compared with general practitioner (GP)-led usual care after 26 weeks of follow-up in individuals with plantar heel pain (PHP) from a societal perspective.

Design

Cost-effectiveness analysis of a double-blinded randomised controlled trial.

Setting

General practice in the Netherlands.

Participants

116 participants with PHP for at least 2 weeks, aged 18–65 years and presenting to the GP.

Interventions

Participants were randomised to GP-led usual care (n=46) or referral to a podiatrist for treatment with a custom-made insole (n=70). Participant randomised to a sham insole (n=69) were excluded from this analysis.

Primary and secondary outcomes

Outcomes comprised pain during rest and activity, and quality of life. Costs included healthcare and lost productivity costs. Statistical uncertainty was estimated using bootstrapping and presented using cost-effectiveness acceptability curves.

Results

Participants in the custom-made insole group experienced statistically significant more pain during activity at 26 weeks than participants in the usual care group (overall effect 1.06; 95% CI 0.36 to 1.75). There were no significant differences between groups in other outcomes. Total societal costs in the custom-made insole group were non-significantly higher than in the usual care group (mean difference €376; 95% CI −€1775 to €2038). The intervention with custom-made insoles was dominated by usual care by the GP (ie, more expensive and less effective) for pain during activity and quality of life outcomes. For the outcome pain at rest, the intervention was more expensive and more effective than usual care. However, the maximum probability of cost-effectiveness was only 0.59 at very high ceiling ratios.

Conclusions

These findings show that that custom-made insoles are not cost-effective in comparison with GP-led usual care. Clinicians should be reserved in prescribing custom-made insoles for PHP as a primary intervention.

Trial registration number

NTR5346.

SUBMITTER: Rasenberg N

PROVIDER: S-EPMC8572391 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundA 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.MethodsA 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.DiscussionThis 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.Trial registrationClinicalTrials.gov: NCT01865734.

Project description:Each time the foot contacts the ground during running there is a rapid deceleration that results in a shock wave that is transmitted from the foot to the head. The fatigue of the musculoskeletal system during running may decrease the ability of the body to absorb those shock waves and increase the risk of injury. Insoles are commonly prescribed to prevent injuries, and both custom-made and prefabricated insoles have been observed to reduce shock accelerations during running. However, no study to date has included a direct comparison of their behaviour measured over the same group of athletes, and therefore great controversy still exists regarding their effectiveness in reducing impact loading during running. The aim of the study was to analyse the acute differences in stride and shock parameters while running on a treadmill with custom-made and prefabricated insoles. Stride parameters (stride length, stride rate) and shock acceleration parameters (head and tibial peak acceleration, shock magnitude, acceleration rate, and shock attenuation) were measured using two triaxial accelerometers in 38 runners at 3.33 m/s before and after a 15-min intense run while using the sock liner of the shoe (control condition), prefabricated insoles and custom-made insoles. No differences in shock accelerations were found between the custom-made and the control insoles. The prefabricated insoles increased the head acceleration rate (post-fatigue, p = 0.029) compared to the control condition. The custom-made reduced tibial (pre-fatigue, p = 0.041) and head acceleration rates (pre-fatigue and post-fatigue, p = 0.01 and p = 0.046) compared to the prefabricated insoles. Neither the stride nor the acceleration parameters were modified as a result of the intense run. In the present study, the acute use of insoles (custom-made, prefabricated) did not reduce shock accelerations compared to the control insoles. Therefore, their effectiveness at protecting against injuries associated with elevated accelerations is not supported and remains unclear.

Project description:Objective:Ready-made spectacles have been suggested as a less resource-intensive treatment for the millions of people living with uncorrected refractive error (URE) in low-income environments. In spite of this interest, there have been no published economic evaluations examining the cost-effectiveness of ready-made spectacles. This study aims to determine the relative cost-effectiveness of offering ready-made spectacles (RMS) relative to no intervention as well as the relative cost-effectiveness of custom-made spectacles (CS) relative to RMS to treat URE. Methods and analysis:The relative cost-effectiveness of RMS relative to CS and no intervention was tested through a cost-effectiveness analysis from the health service provider perspective conducted alongside a double-masked randomised controlled trial in an urban hospital in Delhi, India. Participants were adults aged 18-45 years with ?1?dioptre (D) of URE. Results:There was no significant difference between the effectiveness of the CS and RMS interventions in improving visual acuity, but the CS was over four times the price of the RMS per patient (204 INR (US$2.42) and 792 INR (US$11.22)). The cost per unit improvement in logarithm of the minimum angle of resolution (logMAR) relative to baseline with the RMS intervention was 407 INR (US$4.35). Existing estimates of utility resulting from improvements in visual acuity result in incremental cost per quality-adjusted life years gained of between 212 INR and 1137 INR (US$0.44-US$23.74) depending on the source of the utility estimate and assumed expected life of the spectacles. Conclusion:RMS represent a significantly cost-effective option for spectacle provision in low-resource settings. The RMS programme was substantially cheaper than an equivalent CS intervention while being effective in improving visual acuity for the majority of adults with refractive error in this setting. These findings provide further support for including RMS in programmes to address URE. Trial registration number:NCT00657670, Results.

Project description:BackgroundPlantar heel pain (plantar fasciitis) is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain.MethodsEighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria) will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i) real dry needling or (ii) sham dry needling. The protocol (including needling details and treatment regimen) was formulated by general consensus (using the Delphi research method) using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two) and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version). Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle.ConclusionThis study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials and the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines. The findings from this trial will provide evidence for the effectiveness of trigger point dry needling for plantar heel pain.Trial registrationAustralian New Zealand 'Clinical Trials Registry'. ACTRN12610000611022.