Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

ConditionRotator Cuff Arthropathy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-85

SponsorUniversity of Aarhus

About this trial

Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if RSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with rotator cuff arthropathy eligible for unilateral RSA. The investigators hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (14-point, on a scale from 0-100) improvement compared to the exercise intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 60-85 years

Eligible for RSA

Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)

Disqualifiers

Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)

Planned other upper extremity surgery within six months

Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA

Cancer diagnosis and receiving chemo-, immuno- or radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

TSA-group
Procedure/Surgery
Reverse total shoulder arthroplasty followed by standard rehabilitation.
Exercise-group
Other intervention
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.

Treatment groups

102 Participants

are divided into 2 treatment groups

Group A: RSA-groupExperimental treatment 1 intervention

Group B: Exercise-groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

the Western Ontario Osteoarthritis of the Shoulder index (WOOS)

WOOS consist of 19 items to be answered using a visual analog scale (VAS). Each item has a possible score ranging from 0 to 100, leading to a total WOOS score ranging from 0 to 1900, with 0 being the best. For simplicity reasons, raw scores can be converted to a percentage of the maximum score (0-100, 100 best).

Time frame

Measured at 12 month follow-up

Secondary outcomes

the Western Ontario Osteoarthritis of the Shoulder index (WOOS)

Time frame

Measured at baseline, 12-week, 2-, 5- and 10-year follow-up

Disabilities of the Arm, Shoulder and Hand (DASH)

DASH is a self-administered questionnaire that consist of thirty core items and eight items assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, and lower scores correlated to minimal impairments and higher scores indicate more impairment. The cumulative DASH score is scaled from 0-100 with higher scores indicating more disability

Time frame

Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

The change in pain measured on a 100 mm Visual Analogue Scale (VAS)

Patient reported pain intensity at rest, during activity and nightly pain. With a possible score ranging from 0 to 100, with 100 indicating the worst possible pain

Time frame

Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

The use of analgesics during the last week

The patients will be asked if they take any analgesics (yes/no)

Time frame

Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

Other outcomes

Accelerometer-based activity using tri-axial (Axivity, UK) accelerometers

The patients will have an accelerometer sensor mounted with tape to both upper arms for 4 days. The sensors will measure 24/7 activity of the upper arms.

Time frame

Measured at baseline and 12-month follow-up

Accelerometer-based degree of movement using tri-axial (Axivity, UK) accelerometers

The patients will have an accelerometer sensor mounted with tape to both upper arms for 4 days. The sensors will measure 24/7 degree of movement.

Time frame

Measured at baseline and 12-month follow-up

The 100 mm Visual Analogue Scale (exercise-group)

Patient reported pain intensity at rest. With a possible score ranging from 0 to 100, with 100 indicating the worst possible pain.

Time frame

Measured immediately before and immideately after each exercise session. From the date of the start of the exercise intervention until the end of the exercise intervention, assessed up to 12 months.

EuroQol Group 5-dimension 5-level (EQ-5D-5L)

The EuroQol measures the five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension consists of one item, distinguished in five levels. We will used the UK value set in this study, because a Danish value set is not yet available. These values range from -0.285 to 1.0, a value of 1.0 corresponds to full health, 0 corresponds to death and negative values correspond to health status considered to be worse than death.

Time frame

Measured at baseline, 12-week, 12-month, 2- 5- and 10-year follow-up.