Status:
COMPLETED
Tendinopathy Education on the Achilles
Lead Sponsor:
Ruth Chimenti
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Achilles Tendinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized double-blind, placebo-controlled trial with individuals who have chronic Achilles tendinopathy (AT). This study investigates the effects of education on outcomes (specified in hyp...
Detailed Description
This feasibility randomized controlled trial was designed to address the following aims: Specific Aim 1 examines if education on central pain mechanisms (i.e. biopsychosocial approach) compared to ed...
Eligibility Criteria
Inclusion
- Primary source of pain localized to Achilles tendon insertion or midportion
- Localized pain at least 3/10 in the Achilles tendon (midportion, insertion, unilateral or bilateral) during walking, heel raises, or hopping
- Pain that increases (\>1 point on 11-point scale) with increasing load
Exclusion
- Younger than 18 years of age
- Inability to read and write in English
- Achilles tendon pain for less than 3 months
- History of Achilles tendon rupture that was verified with surgical or conservative management
- History of invasive intervention (surgery, tenex) for AT on more painful side
- Non-invasive treatment (physical therapy, nitroglycerine patch, iontophoresis, injection) for AT in the past 3 months
- Diagnosed with systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis), endocrine disorder with complications (e.g. Uncontrolled Type I or II diabetes, Diabetic peripheral neuropathy), connective tissue disorder (e.g. Marfan's syndrome)
- Cardiovascular conditions that may be exacerbated by a 90 second submersion of hand in cold water (Raynaud's, cold contact uticaria)
- History of taking fluoroquinolones within the past 3 months
- History of corticosteroid injection to foot/ankle/leg within the past 3 months
- Foot and ankle pain primarily due to other pathology, such as posterior impingement, bursitis, paratendonitis, sural nerve injury, ankle osteoarthritis, or radicular/referred symptoms (pain, altered sensation, weakness, altered reflexes) from lumbar spine into lower extremities
- Four step square test \>15 seconds
- Additional exclusion criteria for online only visits:
- Unable to successfully complete virtual visits with a webcam and/or Prefer only in-person visits
- Virtual Fall risk assessment: Stay Independent score \>4\[56\]
- Symptoms indicating need for in-person blood pressure monitoring: 1) Inconsistent use of HTN meds, and/or 2) any recent/current associated symptoms with uncontrolled HTN
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04059146
Start Date
September 18 2019
End Date
March 10 2021
Last Update
March 1 2024
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242