Rotator Cuff Tendinopathy Exercise Trial (RoCTEx)

Progressive Heavy Strength Training Compared to General Low-load Exercises in Patients With Rotator Cuff Tendinopathy: a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tendinitis
• Intervention / Treatment: Other: Low Load Exercises; Other: Progressive Heavy Strength Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fyn
    • Odense, Fyn, Denmark, 5000
      • Odense University Hospital - Svendborg Hospital
  • Jutland
    • Aalborg, Jutland, Denmark, 9800
      • Aalborg University Hospital - Himmerland Hospital
    • Vejle, Jutland, Denmark, 7100
      • Hospital Lillebaelt - Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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. 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.	Other: Progressive Heavy Strength Exercises; 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: Exercise; Strength training; Physiotherapy; Scapular stabilization; Rotator Cuff; Posture; Progressive exercise
ACTIVE_COMPARATOR: Low Load Exercises; 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.	Other: Low Load Exercises; 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: Exercise; Strength training; Physiotherapy; Scapular stabilization; Rotator Cuff; Posture; Progressive exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks	Baseline and 12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tendon quality measured on ultra-sonography at 12 weeks		Baseline and 12 weeks
Baseline demographic and Socioeconomic variables measured at 52 weeks	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	Baseline and 52 weeks

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; Aalborg University Hospital; Sygehus Lillebaelt; Region of Southern Denmark
• Investigators: Study Director: Birgit Juul-Kristensen, Ass. Prof, University of Southern Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Protocol article

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (ESTIMATE): November 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Shoulder; Subacromial Impingement Syndrome; Physiotherapy; Impingement; Rotator Cuff Syndrome
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: RoCTExPRIMARY