Rotator Cuff Tendinopathy Exercise Trial (RoCTEx)

This study is currently recruiting participants.
Verified January 2014 by University of Southern Denmark
Sponsor:
Collaborators:
Region Southern Denmark
Lillebaelt Hospital
Aalborg Universityhospital
Odense University Hospital
Information provided by (Responsible Party):
Kim Gordon Ingwersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01984203
First received: October 31, 2013
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

This study aims at determine if Progressive Heavy Load Exercises (PHLE) as treatment for patients diagnosed with Rotator Cuff Tendinopathy is superior to "Standard Low-Load Exercises" (LLE).


Condition Intervention
Rotator Cuff Tendinopathy
Other: Active comparator
Other: Experimental

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Isometric Strength (MVC) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Range of movement [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients referred to or completed arthroscopic shoulder operation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depressions score - (HAD) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Scapula Retraction test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Scapula Assisted Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in Euro Qol 5D index (EQ 5D) at 12 weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change in Euro Qol 5D index (EQ 5D) at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in tendon quality measured on ultra-sonography at 12 weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Baseline demographic and Socioeconomic variables measured at 52 weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Age, sex, duration of symptoms, symptom history, number of patients receiving corticosteroid injections, visits at the patients general practitioner related to their shoulder problem, visits at the secondary healthcare system related to their shoulder problem, sick leave


Estimated Enrollment: 260
Study Start Date: November 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progressive Heavy Strength Exercises
The Progressive Heavy Load Exercise group gradually increases the external load from 60%RM to 90%RM and correspondently decreases the number of performed repetitions pr. set for the two rotator cuff exercises. Furthermore 4 sets is performed.
Other: Experimental

A progressive exercise program consisting of 6 active exercises.

  • Two exercises for the rotator cuff: Full Can and Sidelying external rotation
  • Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus
  • Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction.

All scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).

The rotator cuff exercises are performed with 4 sets of gradually progressive loading and decreasing the repetitions performed in each set.

Week 1: 15reps (70% 1RM) Week 2-3: 12 reps (75% 1RM) Week 4-5: 10 reps (80% 1RM) Week 6-8: 8 reps (85% 1RM) Week 9-12: 6 reps (90% 1RM)

The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).

Other Names:
  • Scapular stabilization
  • Rotator Cuff
  • Exercise
  • Physiotherapy
  • Posture
  • Progressive exercise
  • Strength training
Active Comparator: Low Load Exercises
Active exercises comparator continuously training with 60%RM through 12 weeks.
Other: Active comparator

A progressive exercise program consisting of 6 active exercises.

  • Two exercises for the rotator cuff: Full Can and Sidelying external rotation
  • Two exercises for the scapulae stabilizing muscles: Low Row and Push-Up Plus
  • Two glenohumeral/postural corrective exercises: Posterior GH stretch and Scapular Retraction.

All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).

The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition).

Other Names:
  • Scapular stabilization
  • Rotator Cuff
  • Exercise
  • Physiotherapy
  • Posture
  • Progressive exercise
  • Strength training

Detailed Description:

The trial will be performed as a multicenter randomised controlled trail, including 260 patients diagnosed with Rotator Cuff Tendinopathy from four orthopaedic shoulder clinics in secondary sector in Denmark.

The PHLE intervention will consist of progressive strengthening exercises performed with heavy load dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with six control visits at a physiotherapy department at the hospitals.

The LLE exercise program consists of the same exercises as the PHLE, but performed with low load dumbbells.

"Disability of the Arm, Shoulder and Hand (DASH) questionnaire" is used as the primary outcome and is measured 12 weeks post baseline.

12 months post baseline a secondary follow-up will be performed primarily measuring the number of patients referred to an operation.

Patients will be randomised to either PHLE or LLE regime by blocks according to whether they have been referred to corticosteroid injection by their orthopaedic shoulder specialist.

Primary investigator and patients will be blinded towards group assignment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 18 and 65 years of age
  • history of shoulder complaints lasting at least 3 months prior to enrolment
  • Pain located in the proximal lateral aspect of the upper arm (C5 dermatome) aggravated by abduction
  • Positive "Full Can test" AND/OR "Jobes test/Empty Can test" AND/OR "Resisted External Rotation test"
  • Positive "Hawkins-Kennedy test AND/OR Neers test
  • Ultra-sonographic verification of tendon swelling, hypo echoic areas, fibrillar disruption or neovascularization in the RC.

Exclusion Criteria:

  • Resting pain more than 40 mm on a visual analogue scale (VAS);
  • Bilateral shoulder pain
  • Less than 90 degrees of active elevation of the arm;
  • Full thickness RC rupture verified by ultra-sonography;
  • Corticosteroid injection within the last 6 weeks;
  • Radiologic verified fracture, calcification larger then 5 mm (vertical distance) in the RC tendon, glenohumeral arthrosis or malalignment in the shoulder complex;
  • Prior surgery or dislocation of the affected shoulder;
  • Clinically suspected labrum lesion, arthritis in the AC-joint, frozen shoulder or symptoms derived from the cervical spine;
  • Sensory or motor deficit in neck or arm;
  • Suspected competing diagnoses (e.g., Rheumatoid arthritis, Cancer, Neurological disorders, Fibromyalgia, Schizophrenia, Suicidal threatened, Borderline personality disorder, or Obsessive Compulsive Disorder);
  • Pregnancy;
  • Inability to fluently understand written and spoken Danish.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984203

Contacts
Contact: Kim Ingwersen, MSc,PhD.stud +4523489320 kingwersen@health.sdu.dk
Contact: Birgit Juul-Kristensen, Associate professor +4565503412 bjuul-kristensen@health.sdu.dk

Locations
Denmark
Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark Not yet recruiting
Odense, Fyn, Denmark, 5230
Contact: Birgit Juul-Kristensen, Associate professor         
Principal Investigator: Kim G Ingwersen, MSc.PhD.stud         
Odense University Hospital - Svendborg Hospital Not yet recruiting
Odense, Fyn, Denmark, 5000
Contact: Hans R Jørgensen, MD         
Principal Investigator: Kim G Ingwersen, MSc.PhD.stud         
Aalborg University Hospital - Himmerland Hospital Not yet recruiting
Aalborg, Jutland, Denmark, 9800
Contact: Sten L Rasmussen, MD         
Contact: Steen Jensen, MD         
Principal Investigator: Kim G Ingwersen, MSc.PhD.stud         
Hospital Lillebaelt - Vejle Hospital Recruiting
Vejle, Jutland, Denmark, 7100
Contact: Lilli Soerensen, MD    +457940 6784    lilli.sorensen@rsyd.dk   
Principal Investigator: Kim G. Ingwersen, MSc.PhD.stud         
Sponsors and Collaborators
University of Southern Denmark
Region Southern Denmark
Lillebaelt Hospital
Aalborg Universityhospital
Odense University Hospital
Investigators
Study Director: Birgit Juul-Kristensen, Associate professor University of Southern Denmark
  More Information

No publications provided

Responsible Party: Kim Gordon Ingwersen, MSc, PhD.stud., University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01984203     History of Changes
Other Study ID Numbers: RoCTExPRIMARY
Study First Received: October 31, 2013
Last Updated: January 20, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Southern Denmark:
Shoulder
Impingement
Rotator Cuff Syndrome
Subacromial Impingement Syndrome
Exercise
Physiotherapy

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014