NCT01423682

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration 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

August 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

August 23, 2011

Last Update Submit

November 18, 2021

Conditions

Rotator Cuff Tendinopathy

Outcome Measures

Primary Outcomes (3)

  • Tendon thickness measurement

    Grey scale ultrasound examination is used.

    After 30 minutes rest, before performing the exercise.

  • Tendon vascularisation examination.

    Power Doppler ultrasound examination is used.

    After 30 minutes rest, before performing the exercise.

  • Microcirculation around the tendon examination.

    Oxygen to see (spectrophotometry and laser Doppler) will be used.

    After 30 minutes rest, before performing the exercise.

Secondary Outcomes (3)

  • Tendon thickness measurements.

    10 minutes after performing the exercise.

  • Tendon vascularisation examination.

    10 minutes after performing the exercise.

  • Microcirculation around the tendon examination.

    10 minutes after performing the exercise.

Study Arms (2)

Healthy subjects

PLACEBO COMPARATOR
Behavioral: Eccentric exercise

Rotator cuff tendinopathy

ACTIVE COMPARATOR
Behavioral: Eccentric exercise

Interventions

Eccentric exerciseBEHAVIORAL

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.

Healthy subjectsRotator cuff tendinopathy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male/ Female
  • 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
  • /3 impingement tests positive
  • /4 resistance tests positive
  • Pain at insertion rotator cuff

You may not qualify if:

  • Spurling test positive
  • Shoulder surgery in the past
  • Osteoarthritis shoulder
  • Full thickness ruptures
  • Male/ Female
  • years old
  • Shoulder pain during the last 3 months
  • Shoulder surgery in the past
  • Neck pain or disability
  • Systemic disease (e.g. Marfan, Ehlers Danlos,…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Study Officials

  • Ann Cools, MD, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

BE(1)