Clinical trial NCT01984203: Rotator Cuff Tendinopathy Exercise Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendinitis
Keywords: Shoulder
Impingement
Rotator Cuff Syndrome
Subacromial Impingement Syndrome
Exercise
Physiotherapy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Sygehus Lillebaelt
name: Aalborg University Hospital
name: Odense University Hospital
First posted: 2013-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Disability of the Arm, Shoulder and Hand questionnaire at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in Isometric Strength (MVC)
timeFrame: Baseline and 12 weeks
measure: Change from baseline in Range of movement
timeFrame: Baseline and 12 weeks
measure: Number of patients referred to or completed arthroscopic shoulder operation
timeFrame: 12 months
measure: Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Hospital Anxiety and Depressions score - (HAD)
timeFrame: Baseline
measure: Scapula Retraction test
timeFrame: Baseline
measure: Scapula Assisted Test
timeFrame: Baseline
measure: Change in Euro Qol 5D index (EQ 5D) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks
timeFrame: Baseline and 52 weeks
measure: Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks
timeFrame: Baseline and 52 weeks
measure: Change in Euro Qol 5D index (EQ 5D) at 52 weeks
timeFrame: Baseline and 52 weeks
Other outcomes:
measure: Change in tendon quality measured on ultra-sonography at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Baseline demographic and Socioeconomic variables measured at 52 weeks
timeFrame: Baseline and 52 weeks
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital - Svendborg Hospital
state: Fyn
city: Aalborg
country: Denmark
facility: Aalborg University Hospital - Himmerland Hospital
state: Jutland
city: Vejle
country: Denmark
facility: Hospital Lillebaelt - Vejle Hospital
state: Jutland
Study officials:
affiliation: University of Southern Denmark
name: Birgit Juul-Kristensen, Ass. Prof
role: STUDY_DIRECTOR
References:
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.
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.
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.