Clinical trial NCT04380285: Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics
Official title: Treating Heel Pain Associated With Plantar Fasciitis in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heel Pain Syndrome
Keywords: Foot
Heel Pain
Plantar Fasciitis
Orthotic Devices
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Secondary outcomes:
measure: 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.
timeFrame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
measure: 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.
timeFrame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Aileen Davis, PhD,BScPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seligman DAR, Dawson D, Streiner DL, Seligman DJ, Davis A. Treating Heel Pain in Adults: A Randomized Controlled Trial of Hard vs Modified Soft Custom Orthotics and Heel Pads. Arch Phys Med Rehabil. 2021 Mar;102(3):363-370. doi: 10.1016/j.apmr.2020.10.124. Epub 2020 Nov 18.