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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380285
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Deborah Seligman, MSc., B.Sc.O.T., University of Toronto

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.

Condition or disease Intervention/treatment Phase
Heel Pain Syndrome Device: Custom heel pads and modified soft molded orthotics Device: Custom hard orthotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Treatment
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
Actual Study Start Date : January 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

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
Device: Custom heel pads and modified soft molded orthotics
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.
Device: Custom hard orthotic



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380285


Sponsors and Collaborators
Deborah Seligman, MSc., B.Sc.O.T.
Investigators
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Principal Investigator: Aileen Davis, PhD,BScPT University of Toronto
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Responsible Party: Deborah Seligman, MSc., B.Sc.O.T., Occupational Therapist, University of Toronto
ClinicalTrials.gov Identifier: NCT04380285    
Other Study ID Numbers: #9964
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol, measurement tools, interventions used.
Supporting Materials: Study Protocol
Time Frame: 6 months after publication for a period of 6 months
Access Criteria: can email principle investigator/author directly

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Seligman, MSc., B.Sc.O.T., University of Toronto:
Foot
Heel Pain
Plantar Fasciitis
Orthotic Devices
Additional relevant MeSH terms:
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Fasciitis
Musculoskeletal Diseases