MedDataX Logo

The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects

NCT ID: NCT01423682

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in causing pain. Tendons suffer large compression and friction, which can lead to degeneration of these tendons. Rehabilitation often leads to unsatisfying results.

In Achilles and patella tendinopathy, a new training program called eccentric training has shown very good results. Eccentric training contains exercises during which a force has to be resisted while the muscle lengthens instead of shortens. This would have a larger influence on tendon tissue. Some small studies also show promising results of eccentric training in patients with rotator cuff tendinopathy but the mechanisms behind these results remain unclear.

To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will be evaluated before and immediately after performing the exercise. Three measurements will be done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive, pain free and without risks for the human body.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tendinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy subjects

Group Type PLACEBO_COMPARATOR

Eccentric exercise

Intervention Type BEHAVIORAL

Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.

Rotator cuff tendinopathy

Group Type ACTIVE_COMPARATOR

Eccentric exercise

Intervention Type BEHAVIORAL

Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eccentric exercise

Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male/ Female
* 18-40 years old
* Unilateral shoulder pain for at least 3 months
* Pain of at least 3/10 on a visual analogue scale
* Painful arc or pain at end range abduction
* 2/3 impingement tests positive
* 2/4 resistance tests positive
* Pain at insertion rotator cuff


* Male/ Female
* 18-40 years old

Exclusion Criteria

* Spurling test positive
* Shoulder surgery in the past
* Osteoarthritis shoulder
* Full thickness ruptures


* Shoulder pain during the last 3 months
* Shoulder surgery in the past
* Neck pain or disability
* Systemic disease (e.g. Marfan, Ehlers Danlos,…)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann Cools, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/482

Identifier Type: -

Identifier Source: org_study_id