- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04380285
Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics
May 5, 2020 updated by: Deborah Seligman, MSc., B.Sc.O.T.
Treating Heel Pain Associated With Plantar Fasciitis in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1. 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
|
|
Active Comparator: Group 2. Custom hard orthotics
Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings.
|
What is the study measuring?
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.
Time Frame: 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)
|
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.
Time Frame: 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)
|
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.
Time Frame: 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.
|
This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aileen Davis, PhD,BScPT, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2003
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
April 28, 2020
First Submitted That Met QC Criteria
May 5, 2020
First Posted (Actual)
May 8, 2020
Study Record Updates
Last Update Posted (Actual)
May 8, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #9964
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study protocol, measurement tools, interventions used.
IPD Sharing Time Frame
6 months after publication for a period of 6 months
IPD Sharing Access Criteria
can email principle investigator/author directly
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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