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

NCT04380285 | Completed

• 1 other identifier: #9964
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heel Pain Syndrome

Keywords

Foot; Heel Pain; Plantar Fasciitis; Orthotic Devices

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (2)

• 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.

  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.

  This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.

Study Arms (2)

Group 1. Custom heel pads and modified soft molded orthotics

ACTIVE COMPARATOR

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

Group 2. Custom hard orthotics

ACTIVE COMPARATOR

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

Interventions

Custom heel pads and modified soft molded orthotics DEVICE

Group 1. Custom heel pads and modified soft molded orthotics

Custom hard orthotic DEVICE

Group 2. Custom hard orthotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deborah Seligman, MSc., B.Sc.O.T.: lead

Related Publications (1)

• 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.

  PMID: 33217374 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Aileen Davis, PhD,BScPT

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Occupational Therapist

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 8, 2020
• Study Start: January 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication for a period of 6 months
• Access Criteria: can email principle investigator/author directly