Back to resultsSTEP Trial for Heel Fat Pad Syndrome (STEP)
Primary Purpose
Heel Fat Pad Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Loop taping
Control taping
Sponsored by
About this trial
This is an interventional treatment trial for Heel Fat Pad Syndrome
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
Sites / Locations
- Aalborg UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Loop taping
Control taping
Arm Description
Loop taping of the heel fat pad
Control taping of the heel fat pad
Outcomes
Primary Outcome Measures
Change from pre-intervention to immediately post-intervention in Numeric Pain Rating Scale (NPRS) during the most pain-aggravating activity
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.
Secondary Outcome Measures
Change from pre-intervention to 3 days post-intervention in Numeric Pain Rating Scale (NPRS) in the past 24 hours
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.
Change from pre-intervention to 3 days post-intervention in Foot Health Status Questionnaire (FHSQ)
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.
Global Rating of Change (GROC)
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.
Change from pre-intervention to immediately post-intervention in Pain sensitivity by pressure pain thresholds
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.
Change from pre-intervention to immediately post-intervention in Heel fat pad thickness
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.
Full Information
NCT ID
NCT05385796
First Posted
May 16, 2022
Last Updated
September 26, 2022
Sponsor
Northwestern University
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT05385796
Brief Title
STEP Trial for Heel Fat Pad Syndrome
Acronym
STEP
Official Title
Study of Taping for Heel Fat Pad Syndrome (STEP): A Randomized Controlled Crossover Single-blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Aalborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heel Fat Pad Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, controlled, participant-blinded trial, with a 2-arm crossover design.
Masking
Participant
Masking Description
To blind the participants, they will be told that both taping techniques have been used in the clinic and we want to investigate if they are effective and if one works better than the other.
Allocation
Randomized
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Loop taping
Arm Type
Experimental
Arm Description
Loop taping of the heel fat pad
Arm Title
Control taping
Arm Type
Placebo Comparator
Arm Description
Control taping of the heel fat pad
Intervention Type
Other
Intervention Name(s)
Loop taping
Intervention Description
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
Intervention Name(s)
Control taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from pre-intervention to immediately post-intervention in Numeric Pain Rating Scale (NPRS) during the most pain-aggravating activity
Description
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.
Time Frame
pre-intervention, immediately post-intervention
Secondary Outcome Measure Information:
Title
Change from pre-intervention to 3 days post-intervention in Numeric Pain Rating Scale (NPRS) in the past 24 hours
Description
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.
Time Frame
pre-intervention, 3 days post-intervention
Title
Change from pre-intervention to 3 days post-intervention in Foot Health Status Questionnaire (FHSQ)
Description
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.
Time Frame
pre-intervention, 3 days post-intervention
Title
Global Rating of Change (GROC)
Description
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.
Time Frame
3 days post-intervention
Title
Change from pre-intervention to immediately post-intervention in Pain sensitivity by pressure pain thresholds
Description
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.
Time Frame
pre-intervention, immediately post-intervention
Title
Change from pre-intervention to immediately post-intervention in Heel fat pad thickness
Description
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.
Time Frame
pre-intervention, immediately post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison H Chang
Phone
312-908-8273
Email
hsini@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison H Chang
Organizational Affiliation
Northwestern University & Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Christensen
Email
mc@rn.dk
First Name & Middle Initial & Last Name & Degree
Marianne Christensen
12. IPD Sharing Statement
Plan to Share IPD
No
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STEP Trial for Heel Fat Pad Syndrome
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