STEP Trial for Heel Fat Pad Syndrome (STEP)

June 23, 2026 updated by: Northwestern University

Study of Taping for Heel Fat Pad Syndrome (STEP): A Randomized Controlled Crossover Single-blind Clinical Trial

The primary objectives of this study are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). For mechanistic understanding of the effect of the loop taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study objectives are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). We hypothesize that the fat pad loop taping is superior to control taping in immediate and short-term pain reduction and short-term function and mobility improvement. To understand potential mechanisms underlying the benefits of the looping taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness. We hypothesize that applying fat pad loop taping will increase the pressure pain threshold (i.e., diminished pain sensitivity) recorded by a mechanical pressure algometer and increase fat pad thickness quantified by ultrasound. Despite being the second leading cause of plantar heel pain, RCTs for conservative management do not exist. Findings of this proposed project will provide much-needed evidence on effective non-pharmacological managements of HFPS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women 18 to 79 years of age
  • History of plantar heel pain in either foot for at least one week and less than 3 years before enrollment
  • Tenderness on palpation of the heel fat pad
  • Self-reported worst unilateral or bilateral central heel pain of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS) during the past week
  • Pain ≥ 3 on NPRS during at least one of two pain-aggravating activities of 30-sec static single leg standing OR barefoot 20-meter walking assessed during the enrollment screening and before the tape application

Exclusion Criteria:

  • Primary diagnoses of plantar heel pain (e.g., plantar fasciopathy, posterior tibialis tendinopathy, or tarsal tunnel syndrome) other than HFPS
  • Ultrasound-measured plantar fascia thickness ≥ 4mm, combined with clinical presentations of plantar fasciopathy
  • BMI ≥ 35
  • Systemic inflammatory arthritis
  • Diabetes
  • Lumbar radiculopathy
  • Neurological conditions affecting gait and mobility
  • Having received taping for HFPS within the last month
  • Prior heel surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Loop taping
Loop taping of the heel fat pad
Other: Loop taping
The participant lays prone on the treatment table with his/her feet dangling off the table. The physiotherapist cleans the heel with alcohol wipes. Care is taken to avoid erasing skin markings for respective algometer and ultrasound assessment by these wipes. The therapist applies 1-inch-width Elastikon tape around the heel, encircling and bunching the fat pad to centralize it and enhance its fullness and resilience to compression. The tape starts at the middle distal end of the fat pad and loop around the periphery and ends by crossing the starting point at the middle distal end of the fat pad. Two to three overlapping loops will be applied to ensure strong support during weight-bearing activities. Participants will be instructed to wear the loop taping for 3 days and remove the taping after responding to an online survey 3-days post intervention.
Placebo Comparator: Control taping
Control taping of the heel fat pad
Other: Control taping
The participant lays prone on the treatment table with his/her feet dangling off the table. The physiotherapist cleans the heel with alcohol wipes. The therapist applies 1-inch-width Elastikon tape around the heel, lightly encircling the heel fat pad without any force/pressure or attempt to bunch or centralize the fat pad. The tape starts at the middle distal end of the fat pad and loop around the periphery and ends by crossing the starting point at the middle distal end of the fat pad. Two to three overlapping loops will be applied. Participants will be instructed to wear the control taping for 3 days and remove the taping after responding to an online survey 3-days post intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from pre-intervention to immediately post-intervention in Numeric Pain Rating Scale (NPRS) during the most pain-aggravating activity
Time Frame: pre-intervention, immediately post-intervention
The primary outcome is pain experienced during the most pain-aggravating activity (e.g., 30-sec static single leg standing or 20-meter barefoot walking) reported during the initial visit. Participants verbally select a value that corresponds with the intensity of pain that they experience. "0" means "no pain" and "10" means "pain as bad as you can imagine" or "worst pain imaginable". The NPRS, an 11-point (i.e., 0-10) measure of pain intensity, is recommended as a core outcome measure in clinical trials of chronic pain treatments and has excellent reliability and validity for adults with chronic musculoskeletal pain.
pre-intervention, immediately post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from pre-intervention to 3 days post-intervention in Numeric Pain Rating Scale (NPRS) in the past 24 hours
Time Frame: pre-intervention, 3 days post-intervention
Participants verbally select a value that corresponds with the average intensity of pain that they experience in the past 24 hours. Participants verbally select a value that corresponds with the intensity of pain that they experience. "0" means "no pain" and "10" means "pain as bad as you can imagine" or "worst pain imaginable". The NPRS, an 11-point (i.e., 0-10) measure of pain intensity, is recommended as a core outcome measure in clinical trials of chronic pain treatments and has excellent reliability and validity for adults with chronic musculoskeletal pain.
pre-intervention, 3 days post-intervention
Change from pre-intervention to 3 days post-intervention in Foot Health Status Questionnaire (FHSQ)
Time Frame: pre-intervention, 3 days post-intervention
The FHSQ is a self-administered questionnaire consisting of 13 items in 4 domains of foot pain (4 items), foot function (4 items), footwear (3 items), and general foot health (2 items). Each item is rated on a 5-point Likert scale from no (score =1) to severe (score = 5) pain, problems, or limitations. Responses to footwear questions are on a 5-point bipolar Likert scale from strongly disagree to strongly agree regarding shoe fit, discomfort wearing shoes, and shoewear available. Each domain score ranges from 0 (worst foot health) to 100 (optimal foot health). Higher scores indicate better foot health and quality of life. A validated Danish version of FHSQ is available. Good FHSQ test/retest and interrater/intrarater reliability and validity have been established for patients with foot disorders.
pre-intervention, 3 days post-intervention
Global Rating of Change (GROC)
Time Frame: 3 days post-intervention
Another core outcome measure for chronic musculoskeletal pain is the GROC, a widely used single-item instrument that asks each participant to indicate whether and to what extent they perceive change has occurred pre vs. post-intervention. This global rating is unique because, unlike other self-reported outcomes, it allows each participant to decide what he/she considers most important and relevant change. In the proposed study, participants will be queried "With respect to your heel pain, how would you describe it after the intervention compared to before the intervention?" and quantify the perceived change on a 7-point visual analogue scale of -3 to +3, where "-3" indicates "much worse", "0" indicates "no change", and "+3" indicates "much improved". GROC has been demonstrated to be a reliable and valid tool for musculoskeletal conditions.
3 days post-intervention
Change from pre-intervention to immediately post-intervention in Pain sensitivity by pressure pain thresholds
Time Frame: pre-intervention, immediately post-intervention
Pain sensitivity is quantified by measuring pressure pain thresholds (PPT) on the most painful spot on the heel fat pad, confirmed by palpation. Participants lay prone on the examination table, with the feet hanging freely over the edge of the table. The examiner places the 1-cm2 probe of a hand held mechanical pressure algometer perpendicular to the skin, and gradually increase the pressure at a rate of 30 kPa/s. Participants will report when the sensation changes from pressure, to the first onset of pain. This will be repeated three times, with a 30-second break between tests, and the average used for the analysis. The probe location will be marked on the skin to ensure placement consistency between pre- and post-intervention testing. The interrter and intrarater reliability of PPT assessment for patients with plantar heel pain was good at ICC 0.80-0.94 for intrarater and 0.75-0.92 for interrater.
pre-intervention, immediately post-intervention
Change from pre-intervention to immediately post-intervention in Heel fat pad thickness
Time Frame: pre-intervention, immediately post-intervention
An ultrasound unit with a 6-13 MHz transducer frequency will be used to measure the heel fat pad thickness. Participants lay prone on the examination table, with the feet hanging freely over the edge of the table. The plantar fat pad will be marked by a sagittal midline; the ultrasound transducer will be placed on the midline for a transverse scan to measure the largest distance between the calcaneus and the skin. The average of two sonographic measurements will be used for analysis. The intrarater and interrater sonographic assessment of heel fat pad thickness was excellent with the intraclass correlation coefficients (ICCs) ranging from 0.81 to 0.96.
pre-intervention, immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison H Chang, Northwestern University & Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20210042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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