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The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

 

The standard of care for chronic tendinopathy primarily targets a localized area of tendon pain, but this strategy is ineffective for up to 40% of patients with chronic Achilles tendinopathy.  An emerging field of research indicates that changes in the central nervous system (CNS) contribute to pain in patients with orthopaedic injuries, such as tendinopathy. Yet the current standard of care for Achilles tendinopathy does not evaluate or treat CNS pain mechanisms. This study proposes a more global approach by evaluating and treating alterations in how the central nervous system processes chronic tendinopathy pain.

This study proposes 2 independent studies to test how altered processing within the CNS contributes to chronic Achilles tendinopathy (AT) pain.

Specific Aim 1.1 compares measures of altered central processing in patients with chronic AT to adults without chronic pain.

Specific Aim 1.2 determines which indicators of altered central processing persist after a local anesthetic injection eliminates peripheral nociception at the site of AT pain in patients with chronic AT.

Specific Aim 2.1 examines if the addition of pain education to an exercise program for AT is more effective at reducing pain and disability than exercise alone using a randomized controlled trial (RCT) design.

Specific Aim 2.2 determines which indicators of altered central processing are improved by the addition of pain education to an exercise intervention.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • 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 (> or =1 point on 11-point scale) with increasing load

Exclusion Criteria:

  • 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 for AT (e.g. injection, physical therapy, iontophoresis, nitroglycerine patch) in the past 3 months
  • Diagnosed systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis), endocrine disorders with complications (e.g. uncontrolled type 1 or II diabetes, diabetic 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.
  • 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

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Double (Participant, Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

University of Iowa, Iowa City, Iowa, United States, 52242

Study Website:

https://clinicaltrials.gov/ct2/show/NCT04059146?term=NCT04059146&draw=2&rank=1

 

Last Updated: March 2020