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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
Deborah Seligman, MSc., B.Sc.O.T.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 28, 2020
    Last Updated
    May 5, 2020
    Sponsor
    Deborah Seligman, MSc., B.Sc.O.T.
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    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

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    Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics

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