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Completed

NCT Number: NCT01984203

Rotator Cuff Tendinopathy Exercise 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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital - Svendborg Hospital, Odense, Fyn, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training

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).

Other names: Scapular stabilization, Rotator Cuff, Exercise, Physiotherapy, Posture, Progressive exercise, Strength training

Primary outcomes

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

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change from baseline in Isometric Strength (MVC)

    Time frame: Baseline and 12 weeks

  2. Change from baseline in Range of movement

    Time frame: Baseline and 12 weeks

  3. Number of patients referred to or completed arthroscopic shoulder operation

    Time frame: 12 months

  4. Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 12 weeks

    Time frame: Baseline and 12 weeks

  5. Hospital Anxiety and Depressions score - (HAD)

    Time frame: Baseline

  6. Scapula Retraction test

    Time frame: Baseline

  7. Scapula Assisted Test

    Time frame: Baseline

  8. Change in Euro Qol 5D index (EQ 5D) at 12 weeks

    Time frame: Baseline and 12 weeks

  9. Change in Disability of the Arm, Shoulder and Hand questionnaire at 52 weeks

    Time frame: Baseline and 52 weeks

  10. Change in Shoulder injury and Osteoarthritis Outcome Score - (SOOS) at 52 weeks

    Time frame: Baseline and 52 weeks

  11. Change in Euro Qol 5D index (EQ 5D) at 52 weeks

    Time frame: Baseline and 52 weeks

Other outcomes

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

    Time frame: Baseline and 12 weeks

  2. Baseline demographic and Socioeconomic variables measured at 52 weeks

    Time frame: Baseline and 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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Odense University Hospital
  • Region of Southern Denmark
  • Sygehus Lillebaelt

Registry information

Official study title

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

Acronym: RoCTEx

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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