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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

NCT00765843

Plantar Fasciitis

COMPLETED NA

Plantar Fasciitis and the Use of Orthotics as Treatment

NCT04894383

Plantar Fascitis

COMPLETED NA

Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment

NCT01882894

Plantar Fasciitis

UNKNOWN NA

Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain

NCT06318910

Foot Orthoses Fasciitis, Plantar

NOT_YET_RECRUITING NA

An Evaluation of a Customized Insole to Provide Relief From Heel Pain Due to Plantar Fasciitis or General Heel Pain When Used in Footwear Over a Period of Four Weeks

NCT03507478

Foot Orthoses

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heel Pain Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Custom heel pads and modified soft molded orthotics

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Custom hard orthotic

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Custom heel pads and modified soft molded orthotics

Intervention Type DEVICE

Custom hard orthotic

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes