Clinical trial NCT05385796: STEP Trial for Heel Fat Pad Syndrome
Official title: Study of Taping for Heel Fat Pad Syndrome (STEP): A Randomized Controlled Crossover Single-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heel Fat Pad Syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-05-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, controlled, participant-blinded trial, with a 2-arm crossover design.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from pre-intervention to immediately post-intervention in Numeric Pain Rating Scale (NPRS) during the most pain-aggravating activity
timeFrame: pre-intervention, immediately post-intervention
Secondary outcomes:
measure: Change from pre-intervention to 3 days post-intervention in Numeric Pain Rating Scale (NPRS) in the past 24 hours
timeFrame: pre-intervention, 3 days post-intervention
measure: Change from pre-intervention to 3 days post-intervention in Foot Health Status Questionnaire (FHSQ)
timeFrame: pre-intervention, 3 days post-intervention
measure: Global Rating of Change (GROC)
timeFrame: 3 days post-intervention
measure: Change from pre-intervention to immediately post-intervention in Pain sensitivity by pressure pain thresholds
timeFrame: pre-intervention, immediately post-intervention
measure: Change from pre-intervention to immediately post-intervention in Heel fat pad thickness
timeFrame: pre-intervention, immediately post-intervention
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Northwestern University & Aalborg University
name: Alison H Chang
role: PRINCIPAL_INVESTIGATOR
References: