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

Rotator Cuff Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423682
• Other study ID #: 2011/482
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria Patients:

• 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

Exclusion Criteria Patients:

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

Inclusion Criteria Healthy subjects:

• Male/ Female
• 18-40 years old

Exclusion Criteria Healthy subjects:

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

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Rotator Cuff Tendinopathy
• Tendinopathy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tendon thickness measurement	Grey scale ultrasound examination is used.	After 30 minutes rest, before performing the exercise.
Primary	Tendon vascularisation examination.	Power Doppler ultrasound examination is used.	After 30 minutes rest, before performing the exercise.
Primary	Microcirculation around the tendon examination.	Oxygen to see (spectrophotometry and laser Doppler) will be used.	After 30 minutes rest, before performing the exercise.
Secondary	Tendon thickness measurements.	Grey scale ultrasound examination is used.	10 minutes after performing the exercise.
Secondary	Tendon vascularisation examination.	Power Doppler ultrasound examination is used.	10 minutes after performing the exercise.
Secondary	Microcirculation around the tendon examination.	Oxygen to see (spectrophotometry and laser Doppler) will be used.	10 minutes after performing the exercise.