Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics
Primary Purpose
Heel Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Custom heel pads and modified soft molded orthotics
Custom hard orthotic
Sponsored by
About this trial
This is an interventional treatment trial for Heel Pain Syndrome focused on measuring Foot, Heel Pain, Plantar Fasciitis, Orthotic Devices
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1. Custom heel pads and modified soft molded orthotics
Group 2. Custom hard orthotics
Arm Description
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
Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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.
Full Information
NCT ID
NCT04380285
First Posted
April 28, 2020
Last Updated
May 5, 2020
Sponsor
Deborah Seligman, MSc., B.Sc.O.T.
1. Study Identification
Unique Protocol Identification Number
NCT04380285
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2003 (Actual)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deborah Seligman, MSc., B.Sc.O.T.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heel Pain Syndrome
Keywords
Foot, Heel Pain, Plantar Fasciitis, Orthotic Devices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1. Custom heel pads and modified soft molded orthotics
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2. Custom hard orthotics
Arm Type
Active Comparator
Arm Description
Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings.
Intervention Type
Device
Intervention Name(s)
Custom heel pads and modified soft molded orthotics
Intervention Type
Device
Intervention Name(s)
Custom hard orthotic
Primary Outcome Measure Information:
Title
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.
Description
Measures pain intensity on a numeric rating scale with anchors of 'no pain' (0) to 'pain as bad as you can imagine' (10)
Time Frame
This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Secondary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Title
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.
Description
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.
Time Frame
This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aileen Davis, PhD,BScPT
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33217374
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.
Results Reference
derived
Learn more about this trial
Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics
We'll reach out to this number within 24 hrs