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Trial record 1 of 1 for:    NCT04059146
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Tendinopathy Education on the Achilles (TEAch)

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ClinicalTrials.gov Identifier: NCT04059146
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Ruth Chimenti, University of Iowa

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 hypotheses below) related to participation in an exercise program. Participants will be randomized to one of two educational programs. All participants will receive the same exercise intervention. This study will consent and randomize 66 participants, who will complete 2 in-person evaluation sessions (baseline, 8-week follow-up), 8 treatment sessions with a physical therapist (between baseline and 8-week follow-up), and 1 online evaluation sessions (12-week follow-up).

We hypothesize that 1) a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT, 2) exercise will improve all three pain mechanisms examined in this RCT (increased PPT, decreased kinesiophobia, increased number of heel raises).


Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Other: Pain Education and Exercise Other: Standard Education and Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blinded to type of education program Outcomes assessor will be blinded to treatment group allocation
Primary Purpose: Treatment
Official Title: Tendinopathy Education on the Achilles
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pain Education + Exercise

The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain.

All participants will receive the same progressive Achilles tendon loading exercise program.

Other: Pain Education and Exercise
Participants will be randomly assigned to a pain education group, following biopsychosocial model, or standard of care education, following biomedical model. The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. Participants will be given weekly online exercises to promote engagement with the material, give individual feedback to participants, and assess understanding. In person sessions with the physical therapist will reinforce self-learning and application to a home exercise program.

Active Comparator: Standard Education + Exercise

The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage.

All participants will receive the same progressive Achilles tendon loading exercise program.

Other: Standard Education and Exercise
The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.




Primary Outcome Measures :
  1. Change in Pain (Aim 1) [ Time Frame: Pre-Intervention, Post-intervention (8-week follow-up, 12-week follow-up) ]
    Participants will rate pain using the numeric pain rating scale (NPRS, 11-pt scale from 0 to 10 as worst pain imaginable) during 3 single limb heel raises

  2. Change in Disability (Aim 1) [ Time Frame: Pre-Intervention, Post-intervention (8-week follow-up, 12-week follow-up) ]
    Disability will be assessed with the PROMIS physical function computer adaptive test, which has a mean score of 50 and standard deviation of 10 in the general population. A higher score indicates better physical function.

  3. Change in Nociplastic Pain- CPM (Aim 2) [ Time Frame: Pre-Intervention, Post-intervention (8-weeks) ]
    Conditioned pain modulation (CPM) at the Achilles and hamstring

  4. Change in Psychosocial- Fear of Movement [ Time Frame: Pre-Intervention, Post-intervention (8-weeks, 12-weeks) ]
    Tampa Scale of Kinesiophobia (TSK) rates current level of fear about movement causing pain and injury. Scores range from 17, indicating negligible fear of movement, to 68, indicating extreme fear of pain with movement.

  5. Change in Motor dysfunction- Heel Raises [ Time Frame: Pre-Intervention, Post-intervention (8-weeks, 12-weeks) ]
    Plantarflexor endurance will be quantified with the maximum number of repetitions as well as the repeated heel raise work test


Other Outcome Measures:
  1. Demographics [ Time Frame: Baseline ]
    date of birth, sex, race/ethnicity, height/weight/BMI, description of Achilles tendinopathy symptoms, goals for physical therapy, previous experience with conservative care, comorbidities

  2. Four square step test [ Time Frame: Baseline ]
    Participants will perform a series of steps in a square formation. The duration of time needed to complete the step reflects dynamic balance and mobility.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (>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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059146


Contacts
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Contact: Jing Danielson 319-336-1722 chimenti-lab@healthcare.uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ruth L Chimenti, DPT, PhD       chimenti-lab@uiowa.edu   
Sponsors and Collaborators
Ruth Chimenti
Department of Health and Human Services
Investigators
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Principal Investigator: Ruth Chimenti, DPT, PhD University of Iowa
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Responsible Party: Ruth Chimenti, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04059146    
Other Study ID Numbers: 201904722
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

In compliance with FAIR data principles, data will be deposited in the University of Iowa open-access institutional repository, Iowa Research Online. The repository is open access and maintained by the Libraries at the University of Iowa for the preservation and sharing of intellectual work of faculty, students and staff.

Datasets will be accompanied with appropriate descriptive, technical, and administrative metadata to facilitate discovery and scholarly reuse, and will be assigned unique Digital Objects Identifiers (DOIs) that can be incorporated into publications and cited in the literature. Metadata will be included in the data records in the repository through readme files and structured information following the DataCite metadata schema.

Footnotes:

FAIR Data Principles: https://www.go-fair.org/fair-principles/ IRO: University of Iowa. (2019). Iowa Research Online. http://ir.uiowa.edu/ DataCite metadata: https://schema.datacite.org/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: IPD will be available to other researchers for the primary outcomes of Specific Aims 1 and 2. Results will be posted within 1 year of study completion.
Access Criteria: The URL linking to IPD will be posted within this section and available anyone with access to clinicaltrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries