NCT05385796

STEP Trial for Heel Fat Pad Syndrome

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Heel Fat Pad Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-06-08
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-05-23
• Last updated: 2023-11-02

Locations

1 site across 1 country: Denmark