Rotator Cuff Tendinopathy Exercise Trial

Rotator Cuff Tendinitis Clinical Trial

— RoCTEx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984203
• Other study ID #: RoCTExPRIMARY
• 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

• Rotator Cuff Tendinitis
• Tendinopathy

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

External Links

•   Protocol article