Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

Rotator Cuff Arthropathy Clinical Trial

— REACT  

Official title:

Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864158
• Other study ID #: REACT
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: November 2038

Study information

• Verified date: June 2024
• Source: University of Aarhus
• Contact: Josefine B. Larsen, MSc
• Phone: +4526237771
• Email: josefinebl[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Rotator cuff arthropathy describes the clinical scenario of massive rotator cuff ruptures associated with glenohumeral joint degeneration and superior migration of the humeral head. Clinical presentation includes joint effusion, pain, and loss of mobility. Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. Several studies have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments.

The ProAct trial is a Nordic multicenter randomized controlled trial. Patients with rotator cuff arthropathy, eligible for a RSA will be randomised to either RSA followed by usual care or exercise only. The exercise intervention consists of 12 weeks of exercise with one weekly physiotherapist-supervised exercise session.

The primary outcome will be the total the Western Ontario Osteoarthritis of the Shoulder index score at 12 months follow-up. Outcome assessment will be performed at baseline, and at 3 and 12 months and 2-, 5- and 10 years after start of surgical/non-surgical treatment.

Patients fulfilling the eligibility criteria but declining to participate in the randomised trial will be offered the option of participating in an observational cohort using the same primary end point and patient reported outcomes, but following usual clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: November 2038
• Est. primary completion date: November 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients 60-85 years

• Eligible for RSA

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

Exclusion Criteria:

• 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

• Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)

• Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.

• Unable to communicate in the participating countries respective languages

Related Conditions & MeSH terms

• Joint Diseases
• Rotator Cuff Arthropathy

Intervention

Procedure:
• TSA-group
Reverse total shoulder arthroplasty followed by standard rehabilitation.

Other:
• Exercise-group
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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N, 8200
Denmark	Esbjerg Hospital	Esbjerg
Denmark	Aalborg University Hospital	Farsø
Denmark	Silkeborg Regional Hospital	Silkeborg
Denmark	Viborg Regional Hospital	Viborg
Finland	Tampere University Hospital	Tampere
Norway	Oslo University Hospital	Oslo

Sponsors (10)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Aarhus University Hospital, Association of Danish Physiotherapists, Esbjerg Hospital, Oslo University Hospital, Regionshospitalet Silkeborg, Regionshospitalet Viborg, Skive, Tampere University Hospital, The Danish Rheumatism Association

Countries where clinical trial is conducted

Denmark,  Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Measured at baseline and 12-month follow-up
Other	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.	Measured at baseline and 12-month follow-up
Other	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.	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.
Other	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.	Measured at baseline, 12-week, 12-month, 2- 5- and 10-year follow-up.
Other	Productivity Costs Questionnaire (iPCQ)	The iPCQ is a questionnaire for the measurement of costs in economic evaluations. It consists of 18 questions of which 9 are general questions followed by questions to measure productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. The minimum value is 0 (no productivity loss) and the maximum value is infinite. Measured for the health economic evaluation in Denmark.	Measured at 12-week and 12-month.
Other	Patient Acceptable Symptom State (PASS)	PASS will be assessed with the following question, reported by the patient: "When you think of your shoulder function, will you consider your current condition as satisfying? By shoulder function, you should take into account your activities of daily living, sport and recreational activities, your shoulder pain and other symptoms and your quality-of-life", measured on a dichotomous scale (yes/no).	Measured at 12-month, 2-, 5- and 10-year follow-up.
Other	Treatment Failure	Patient-reported treatment failure will be assessed only by patients answering "no" to PASS with the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?" on a dichotomous scale (yes/no).	Measured at 12-month, 2-, 5- and 10-year follow-up.
Other	Number of total shoulder arthroplasty surgeries (exercise-group)	Number of total shoulder arthroplasty surgeries performed in the exercise-group.	Measured from baseline to 12-month, 2-, 5- and 10-year follow-up.
Other	Number of supervised exercise sessions from baseline to 3 months (exercise-group)	High compliance will be defined as participation in =70 percent of the training sessions; moderate compliance as participation in 50-70 percent of the sessions; and poor compliance as participation in <50 percent of the sessions.	From baseline to 12-week
Other	Number of patients performing unsupervised exercise (exercise-group)	Adherence to two weekly unsupervised exercise sessions will be measured by a patient-reported questionnaire	From baseline to 12-week
Other	Number of patients performing unsupervised exercise (exercise-group)	Adherence to optional unsupervised exercise sessions will be measured by a patient-reported questionnaire	From 12-week to 12-month
Primary	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).	Measured at 12 month follow-up
Secondary	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).	Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
Secondary	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	Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary	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	Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary	The use of analgesics during the last week	The patients will be asked if they take any analgesics (yes/no)	Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary	The type of analgesics consumed during the last week	The patients will be asked which type of analgesics they take (paracetamol, NSAID, morphine/opioids).	Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary	Consumption of analgesics during the last week	The patients will be asked how often they consume the analgesic medication (never, daily, weekly, monthly).	Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary	Serious Adverse Events	Serious adverse events are defined as embolism (cardiac or brain), death, liver and renal failure.	The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
Secondary	Adverse events	Defined as any unintended and unfavorable sign, symptom or disease resulting in contact with the healthcare system irrespective of a causal relationship with the intervention and outcome assessments.	Occurring during the period from inclusion until the 12-month follow-up