NCT03523325

Brief Summary

This study will evaluate if there is a difference in recovery of tendon structure and mechanical properties between males and females with Achilles tendinopathy receiving exercise treatment. It will evaluate recovery of tendinopathy with exercise intervention using outcome measures for tendon structure and mechanical properties along with validated measures of muscle-tendon function and symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

5.5 years

First QC Date

May 1, 2018

Last Update Submit

June 26, 2024

Conditions

Achilles TendinopathyAchilles TendonitisAchilles Tendon PainAchilles DegenerationAchillodynia

Keywords

TendinopathyTendonRehabilitationExercise treatment

Outcome Measures

Primary Outcomes (4)

  • Symptoms

    Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A), Scale 0-100 with higher scores indicate better outcome.

    Change over time during 12 months with evaluation every 8 weeks

  • Tendon Structure

    Ultrasound imaging of tendon structure

    Change over time during 12 months with evaluation every 8 weeks

  • Tendon Mechanical Properties

    Use of Continuous shear wave elastography to measure shear modulus and viscosity

    Change over time during 12 months with evaluation every 8 weeks

  • Muscle-tendon function

    Functional test battery consisting of one endurance heel-rise test and three jump tests

    Change over time during 12 months with evaluation every 8 weeks

Secondary Outcomes (7)

  • Activity level

    Change over time during 12 months with evaluation every 8 weeks

  • Foot and Ankle related quality of life

    Change over time during 12 months with evaluation every 8 weeks

  • Kinesiophobia

    Change over time during 12 months with evaluation every 8 weeks

  • Physical Activity level

    Change over time during 12 months with evaluation every 8 weeks

  • Pain level

    Change over time during 12 months with evaluation every 8 weeks

  • +2 more secondary outcomes

Interventions

Exercise treatmentOTHER

Treatment protocol is an exercise program consisting of four different phases (Silbernagel protocol). The progression consists of increasing number of repetitions, resistance, speed and range of motion of the exercises. A pain-monitoring model is used to adjust the exercise loads and progression through the four phases.

Also known as: Rehabilitation exercise, Physical Therapy treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Diagnosis of midportion Achilles tendinopathy

You may not qualify if:

  • Previous Achilles tendon rupture
  • Diagnosis of only insertional Achilles tendinopathy or bursitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (3)

  • Smitheman HP, Lundberg M, Harnesand M, Gelfgren S, Gravare Silbernagel K. Putting the fear-avoidance model into practice - what can patients with chronic low back pain learn from patients with Achilles tendinopathy and vice versa? Braz J Phys Ther. 2023 Sep-Oct;27(5):100557. doi: 10.1016/j.bjpt.2023.100557. Epub 2023 Nov 4.

    PMID: 37952338DERIVED

  • Hanlon SL, Pohlig RT, Silbernagel KG. Differences in Recovery of Tendon Health Explained by Midportion Achilles Tendinopathy Subgroups: A 6-Month Follow-up. J Orthop Sports Phys Ther. 2023 Apr;53(4):217-234. doi: 10.2519/jospt.2023.11330. Epub 2023 Jan 23.

    PMID: 36688719DERIVED

  • Sigurethsson HB, Couppe C, Silbernagel KG. Data driven model of midportion achilles tendinopathy health created with factor analysis. BMC Musculoskelet Disord. 2022 Aug 3;23(1):744. doi: 10.1186/s12891-022-05702-1.

    PMID: 35922770DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Exercise TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One intervention with comparison between males and females
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 14, 2018

Study Start

July 2, 2018

Primary Completion

January 12, 2024

Study Completion

March 12, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations

US(1)