Tendinopathy Education on the Achilles

NCT04059146 | Completed Results DMC

• 1 other identifier: 201904722
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (5)

• Pain (Aim 1)

  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

  Pre-Intervention, Post-intervention (8-week follow-up)

• Self-reported Function (Aim 1)

  Self-reported function 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.

  Pre-Intervention, Post-intervention (8-week follow-up, 12-week follow-up)

• Nociplastic Pain- CPM (Aim 2)

  Conditioned pain modulation (CPM) at the Achilles tendon will be calculated as the % change in the pain pressure threshold (PPT) with the hand in cold water (conditioning stimulus) compared to the (PPT) room temperature water.

  Pre-Intervention, Post-intervention (8-weeks)

• Fear of Movement

  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.

  Pre-Intervention, Post-intervention (8-weeks, 12-weeks)

• Performance-based Function: Heel Raises

  Plantarflexor endurance will be quantified with the maximum number of repetitions of single limb heel raises

  Pre-Intervention, Post-intervention (8-weeks)

Other Outcomes (2)

• Demographics

  Baseline

• Four Square Step Test

  Baseline

Study Arms (2)

Pain Education + Exercise

EXPERIMENTAL

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

Standard Education + Exercise

ACTIVE COMPARATOR

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

Interventions

Pain Education and Exercise OTHER

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.

Pain Education + Exercise

Standard Education and Exercise OTHER

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.

Standard Education + Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ruth Chimenti: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Janowski AJ, Post AA, Heredia-Rizo AM, Frey-Law LA, Bayman EO, Sluka KA, Chimenti RL. Exploring biomarkers of change in movement-evoked pain in Achilles tendinopathy: A secondary analysis of a randomized controlled trial. Clin Biomech (Bristol). 2026 Jan;131:106706. doi: 10.1016/j.clinbiomech.2025.106706. Epub 2025 Nov 7.

  PMID: 41207117 DERIVED

• Post AA, Rio EK, Sluka KA, Moseley GL, Bayman EO, Hall MM, de Cesar Netto C, Wilken JM, Danielson J, Chimenti RL. Efficacy of Telehealth for Movement-Evoked Pain in People With Chronic Achilles Tendinopathy: A Noninferiority Analysis. Phys Ther. 2023 Mar 3;103(3):pzac171. doi: 10.1093/ptj/pzac171.

  PMID: 37172125 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Ruth Chimenti
• Organization: University of Iowa

ruth-chimenti@uiowa.edu

319-335-9802

Study Officials

• Ruth Chimenti, DPT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to type of education program Outcomes assessor will be blinded to treatment group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 16, 2019
• Study Start: September 18, 2019
• Primary Completion: February 9, 2021
• Study Completion: March 10, 2021
• Last Updated: March 1, 2024
• Results First Posted: January 11, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (1)