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Tendinopathy Education on the Achilles

NCT04059146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-03-01

Study results available
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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).

Conditions

  • Achilles Tendinopathy

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Ruth Chimenti, DPT, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2021-02-09
Completion
2021-03-10

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04059146 on ClinicalTrials.gov