Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01984203
Other study ID # RoCTExPRIMARY
Secondary ID
Status Completed
Phase N/A
First received October 31, 2013
Last updated November 30, 2015
Start date November 2013
Est. completion date October 2015

Study information

Verified date November 2015
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
Denmark Aalborg University Hospital - Himmerland Hospital Aalborg Jutland
Denmark Odense University Hospital - Svendborg Hospital Odense Fyn
Denmark Hospital Lillebaelt - Vejle Hospital Vejle Jutland

Sponsors (5)

Lead Sponsor Collaborator
University of Southern Denmark Aalborg Universitetshospital, Odense University Hospital, Region of Southern Denmark, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in tendon quality measured on ultra-sonography at 12 weeks Baseline and 12 weeks No
Other 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 No
Primary Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks Baseline and 12 weeks No
Secondary Change from baseline in Isometric Strength (MVC) Baseline and 12 weeks No
Secondary Change from baseline in Range of movement Baseline and 12 weeks No
Secondary Number of patients referred to or completed arthroscopic shoulder operation 12 months No
Secondary Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks Baseline and 12 weeks No
Secondary Hospital Anxiety and Depressions score - (HAD) Baseline No
Secondary Scapula Retraction test Baseline No
Secondary Scapula Assisted Test Baseline No
Secondary Change in Euro Qol 5D index (EQ 5D) at 12 weeks Baseline and 12 weeks No
Secondary Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks Baseline and 52 weeks No
Secondary Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks Baseline and 52 weeks No
Secondary Change in Euro Qol 5D index (EQ 5D) at 52 weeks Baseline and 52 weeks No
See also
  Status Clinical Trial Phase
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Not yet recruiting NCT06023914 - Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength. Phase 2/Phase 3
Completed NCT01402011 - Study of 25% Dextrose Injections in Shoulder Ligaments and Tendons to Promote Their Healing N/A
Completed NCT01355549 - Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury Phase 1
Terminated NCT00764764 - Study of the Effect of Neck Treatment on Shoulder Impingement Phase 1
Completed NCT03892603 - Does The Type of Exercise Influence Outcome in Rotator Cuff Related Shoulder Pain N/A
Active, not recruiting NCT03752827 - Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears N/A
Recruiting NCT05264935 - Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff
Recruiting NCT02967640 - Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy? Phase 2/Phase 3
Terminated NCT04115644 - Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial Phase 4
Completed NCT03425357 - Sonoelastography of the Supraspinatus Tendon N/A
Completed NCT03425344 - Discriminative Validity of Strain Elastography of the Supraspinatus Tendon N/A
Recruiting NCT04923477 - Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms N/A
Not yet recruiting NCT06372600 - Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis N/A
Completed NCT06425913 - Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis N/A
Completed NCT03675399 - Effect of Isometric Exercise on Pain Perception in Rotator Cuff Related Shoulder Pain N/A
Recruiting NCT05489484 - Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome N/A
Recruiting NCT04094298 - Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease Phase 3
Active, not recruiting NCT03167138 - Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury Early Phase 1
Completed NCT03567109 - Body Schema Alterations in Musculoskeletal Disorders : Effect of Laterality

External Links