Rotator Cuff Tendinopathy Exercise Trial

NCT01984203 | Completed

• 1 other identifier: RoCTExPRIMARY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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).

Conditions

Rotator Cuff Tendinitis

Keywords

Shoulder; Impingement; Rotator Cuff Syndrome; Subacromial Impingement Syndrome; Exercise; Physiotherapy

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 12 weeks

Secondary Outcomes (11)

• 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

Other Outcomes (2)

• Change in tendon quality measured on ultra-sonography at 12 weeks

  Baseline and 12 weeks

• Baseline demographic and Socioeconomic variables measured at 52 weeks

  Baseline and 52 weeks

Study Arms (2)

Progressive Heavy Strength Exercises

EXPERIMENTAL

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

Low Load Exercises

ACTIVE COMPARATOR

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

Interventions

Low Load Exercises OTHER

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).

Also known as: Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training

Low Load Exercises

Progressive Heavy Strength Exercises OTHER

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).

Also known as: Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training

Progressive Heavy Strength Exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• Sygehus Lillebaelt: collaborator
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (3)

Odense University Hospital - Svendborg Hospital

Odense, Fyn, 5000, Denmark

Location

Aalborg University Hospital - Himmerland Hospital

Aalborg, Jutland, 9800, Denmark

Location

Hospital Lillebaelt - Vejle Hospital

Vejle, Jutland, 7100, Denmark

Location

Related Publications (3)

• 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.

  PMID: 28875153 DERIVED

• 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.

  PMID: 27221128 DERIVED

• 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.

  PMID: 25622594 DERIVED

Related Links

• Protocol article

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome; Motor Activity

Interventions

Exercise; Physical Therapy Modalities; Posture; Resistance Training

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human

Study Officials

• Birgit Juul-Kristensen, Ass. Prof

  University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhD.stud.

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

DK (3)