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

Deborah Seligman, MSc., B.Sc.O.T.

Status: Completed

Conditions: Heel Pain Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04380285

#9964

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

Group 1. Custom heel pads and modified soft molded orthotics

Active Comparator group

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

Treatment:

Device: Custom heel pads and modified soft molded orthotics

Group 2. Custom hard orthotics

Active Comparator group

Description:

Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings.

Treatment:

Device: Custom hard orthotic