Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics

Study Overview
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Brief Summary
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Objectives: This study compared the effectiveness of soft versus hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost and number of visits for orthotics and explored if age was a factor in orthotic effectiveness.

Detailed Description
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Design: This randomized clinical trial included 44 adults (18+) with heel pain and plantar fasciitis. Participants received hard or soft customized orthotics and rated their pain intensity, pain interference and function, pre and post orthotic use. Scores were analyzed with repeated measures ANOVA. Analysis of age used repeated measures ANOVA. Costs were compared using t-test and number of visits was compared using Wilcoxon Rank Sum.

Official Title
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Treating Heel Pain Associated With Plantar Fasciitis in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads

Conditions
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Heel Pain Syndrome

Intervention / Treatment
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* Device: Custom heel pads and modified soft molded orthotics
* Device: Custom hard orthotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sample of convenience from the hospital and private clinic. The participants had heel pain associated with plantar fasciitis. Participants could describe and report changes in their pain Exclusion Criteria: Those excluded were non-ambulatory (unable to walk greater than 25 meters) orchid spasticity due to a neurological disorder. Others excluded were non-communicative, had cognitive impairment or were unable to complete a questionnaire.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design was a randomized clinical trial.The study was completed when the target number of recruitments was reached. Prior to randomization to treatment groups, patients were stratified by age (younger adults: 18 - 64 years and older adults: 65 years and older) in blocks of four to ensure that there were an equal number of participants receiving soft versus hard orthotics in each age group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1. Custom heel pads and modified soft molded orthotics<br>Modified soft custom orthotics supported in the medial longitudinal arches and medial shock absorbing heel pads with customized cutout at the point corresponding to the heel pain | Device: Custom heel pads and modified soft molded orthotics<br> <br> |
| Active Comparator: Group 2. Custom hard orthotics<br>Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings. | Device: Custom hard orthotic<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory: a sub-scale from this measurement tool measuring pain intensity. Change in pain intensity is being assessed using this measurement tool pre and post treatment. | Measures pain intensity on a numeric rating scale with anchors of 'no pain' (0) to 'pain as bad as you can imagine' (10) | This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory: a sub-scale from this measurement tool measuring pain interference with activity and level of function. Change in pain interference is being assessed using this measurement tool pre and post treatment. | Pain interference was rated on the following items: general activity, walking, work, relations with other people, mood, sleep and enjoyment of life, using a numeric scale with anchors 'does not interfere (0) to 'completely interferes' (10) | This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided. | 
| Late Life Function and Disability Instrument (Late Life FDI): Function component. Change in function is being assessed using this measurement tool pre and post treatment. | It rates one's ability to do a wide variety of activities that involve basic upper and lower extremity function, such as reaching, standing and bending as well as higher levels of physical endurance such as walking and climbing stairs.It is a 32 item self-report questionnaire with five response categories and a score ranging from 32 to 160. | This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foot, Heel Pain, Plantar Fasciitis, Orthotic Devices