STEP Trial for Heel Fat Pad Syndrome

Northwestern University

Status: Enrolling

Conditions: Heel Fat Pad Syndrome

Treatments: Other: Control taping; Other: Loop taping

Study type: Interventional

Funder types: Other

Identifiers

NCT05385796

N-20210042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups, including a placebo group

Loop taping

Experimental group

Description:

Loop taping of the heel fat pad

Treatment:

Other: Loop taping

Control taping

Placebo Comparator group

Description:

Control taping of the heel fat pad

Treatment:

Other: Control taping