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Rotator Cuff Tendinopathy Exercise Trial (RoCTEx)

Primary Purpose

Rotator Cuff Tendinitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low Load Exercises
Progressive Heavy Strength Exercises
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinitis focused on measuring Shoulder, Impingement, Rotator Cuff Syndrome, Subacromial Impingement Syndrome, Exercise, Physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Odense University Hospital - Svendborg Hospital
  • Aalborg University Hospital - Himmerland Hospital
  • Hospital Lillebaelt - Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive Heavy Strength Exercises

Low Load Exercises

Arm Description

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. 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.

Active exercises comparator continuously training with 60%RM through 12 weeks. An 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.

Outcomes

Primary Outcome Measures

Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks

Secondary Outcome Measures

Change from baseline in Isometric Strength (MVC)
Change from baseline in Range of movement
Number of patients referred to or completed arthroscopic shoulder operation
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks
Hospital Anxiety and Depressions score - (HAD)
Scapula Retraction test
Scapula Assisted Test
Change in Euro Qol 5D index (EQ 5D) at 12 weeks
Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks
Change in Euro Qol 5D index (EQ 5D) at 52 weeks

Full Information

First Posted
October 31, 2013
Last Updated
November 30, 2015
Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Sygehus Lillebaelt, Aalborg University Hospital, Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01984203
Brief Title
Rotator Cuff Tendinopathy Exercise Trial
Acronym
RoCTEx
Official Title
Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Sygehus Lillebaelt, Aalborg University Hospital, Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
The trial will be performed as a multicenter randomised controlled trail, including 110 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. *April 2015: (We originally expected to be able to include 260 patients in order to analyze our data according to the sub-groups of exercise group +/- Corticosteroid injection, but inclusion rate has been much lower then expected, and due to time restraints we only expect to include 110 patients) Primary investigator and patients will be blinded towards group assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinitis
Keywords
Shoulder, Impingement, Rotator Cuff Syndrome, Subacromial Impingement Syndrome, Exercise, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Heavy Strength Exercises
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Low Load Exercises
Arm Type
Active Comparator
Arm Description
Active exercises comparator continuously training with 60%RM through 12 weeks. An 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.
Intervention Type
Other
Intervention Name(s)
Low Load Exercises
Other Intervention Name(s)
Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Progressive Heavy Strength Exercises
Other Intervention Name(s)
Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Isometric Strength (MVC)
Time Frame
Baseline and 12 weeks
Title
Change from baseline in Range of movement
Time Frame
Baseline and 12 weeks
Title
Number of patients referred to or completed arthroscopic shoulder operation
Time Frame
12 months
Title
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Hospital Anxiety and Depressions score - (HAD)
Time Frame
Baseline
Title
Scapula Retraction test
Time Frame
Baseline
Title
Scapula Assisted Test
Time Frame
Baseline
Title
Change in Euro Qol 5D index (EQ 5D) at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks
Time Frame
Baseline and 52 weeks
Title
Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks
Time Frame
Baseline and 52 weeks
Title
Change in Euro Qol 5D index (EQ 5D) at 52 weeks
Time Frame
Baseline and 52 weeks
Other Pre-specified Outcome Measures:
Title
Change in tendon quality measured on ultra-sonography at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Baseline demographic and Socioeconomic variables measured at 52 weeks
Description
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
Time Frame
Baseline and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Juul-Kristensen, Ass. Prof
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Odense University Hospital - Svendborg Hospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Aalborg University Hospital - Himmerland Hospital
City
Aalborg
State/Province
Jutland
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Hospital Lillebaelt - Vejle Hospital
City
Vejle
State/Province
Jutland
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28875153
Citation
Ingwersen KG, Jensen SL, Sorensen L, Jorgensen HR, Christensen R, Sogaard K, Juul-Kristensen B. Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial. Orthop J Sports Med. 2017 Aug 28;5(8):2325967117723292. doi: 10.1177/2325967117723292. eCollection 2017 Aug.
Results Reference
derived
PubMed Identifier
27221128
Citation
Ingwersen KG, Hjarbaek J, Eshoej H, Larsen CM, Vobbe J, Juul-Kristensen B. Ultrasound assessment for grading structural tendon changes in supraspinatus tendinopathy: an inter-rater reliability study. BMJ Open. 2016 May 24;6(5):e011746. doi: 10.1136/bmjopen-2016-011746.
Results Reference
derived
PubMed Identifier
25622594
Citation
Ingwersen KG, Christensen R, Sorensen L, Jorgensen HR, Jensen SL, Rasmussen S, Sogaard K, Juul-Kristensen B. Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:27. doi: 10.1186/s13063-014-0544-6.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25622594
Description
Protocol article

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Rotator Cuff Tendinopathy Exercise Trial

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