STEP Trial for Heel Fat Pad Syndrome

NCT ID: NCT05385796

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2024-02-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Loop taping

Loop taping of the heel fat pad

Group Type: EXPERIMENTAL

Loop taping

Intervention Type: OTHER

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.

Control taping

Control taping of the heel fat pad

Group Type: PLACEBO_COMPARATOR

Control taping

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Alison Chang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison H Chang

Role: PRINCIPAL_INVESTIGATOR

Northwestern University & Aalborg University

Locations

Aalborg University

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Alison H Chang

Role: CONTACT

hsini@northwestern.edu

312-908-8273

Facility Contacts

Marianne Christensen

Role: primary

mc@rn.dk

Other Identifiers

N-20210042

Identifier Type: -

Identifier Source: org_study_id