Heel Pain Syndrome
Conditions
Keywords
Foot, Heel Pain, Plantar Fasciitis, Orthotic Devices
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.
Interventions
DEVICECustom heel pads and modified soft molded orthotics
DEVICECustom hard orthotic
Sponsors
Deborah Seligman, MSc., B.Sc.O.T.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The research assistant was blinded to the type of orthotic provided to the participant to prevent possible bias during administration of the post treatment questionnaire.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Outcome results
None listed