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

Heel Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380285
• Other study ID #: #9964
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Est. completion date: August 2005

Study information

• Verified date: May 2020
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Heel Pain Syndrome

Intervention

Device:
• Custom heel pads and modified soft molded orthotics

• Custom hard orthotic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deborah Seligman, MSc., B.Sc.O.T.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Secondary	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.	This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.