Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar … (NCT04162262) | Clinical Trial Compass
CompletedNot Applicable
Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment
United States83 participantsStarted 2019-10-24
Plain-language summary
This study compares the addition instrument-assisted soft tissue mobilization (IASTM) to a program of home strengthening and stretching exercises to see whether adding weekly IASTM treatments improves plantar fasciopathy pain and plantar fascia stiffness.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Plantar Fasciopathy Groups
* age 18-60 years
* self-reported history of plantar heel pain for a minimum of 2 months prior to enrollment
* pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia
* pain is worst when first standing or walking after rest
* willing to attempt not to use additional treatments (e.g., shoe modifications, foot orthoses/braces, injections, or surgery) during the trial period (12 weeks)
* willing to attempt to discontinue taking all pain-relieving medications except Tylenol or ibuprofen for plantar heel pain during the trial period (12 weeks).
Inclusion Criteria for Healthy Comparison Group:
* age and BMI matched with Group 2 subjects
* no history or symptoms of plantar heel pain in the past 12 months
Exclusion Criteria for all three groups:
* history of direct trauma to the foot with plantar fasciopathy
* inflammatory arthritis in the feet/ankle (e.g., ankylosing spondylitis or rheumatoid arthritis)
* metabolic or endocrine disorders (e.g., Type I or II diabetes)
* neurological disorders (e.g., Charcot-Marie-Tooth disease)
* prior foot surgery on the foot with plantar fasciopathy
* pregnancy (by self-report)
* corticosteroid injection to treat plantar fasciopathy in the past 12 weeks
* body mass index \> 35 kg/m2
* receiving or applied for worker compensation benefits
* no physical activity above 5 (moderate activity) on a 10-point Rating of Perceived Exertion scale in the past 24 hours prior to th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Foot Health Status Questionnaire Pain Subscale Score
Timeframe: Week 8
Trial details
NCT IDNCT04162262
SponsorTexas Tech University Health Sciences Center