Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics
- Conditions
- Heel Pain Syndrome
- Interventions
- Device: Custom heel pads and modified soft molded orthoticsDevice: Custom hard orthotic
- Registration Number
- NCT04380285
- Lead Sponsor
- Deborah Seligman, MSc., B.Sc.O.T.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1. Custom heel pads and modified soft molded orthotics Custom heel pads and modified soft molded orthotics 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 Group 2. Custom hard orthotics Custom hard orthotic Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings.
- Primary Outcome Measures
Name Time Method 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. This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided. Measures pain intensity on a numeric rating scale with anchors of 'no pain' (0) to 'pain as bad as you can imagine' (10)
- Secondary Outcome Measures
Name Time Method 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. This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided. 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.
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. This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided. 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)