Cycloergometer and Rotator Cuff Tear

Study Overview
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Brief Summary
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The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine. However, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.

Detailed Description
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To evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness RCT. Since cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of RCT patients.

Official Title
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Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Other: Cycloergometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive imaging diagnosis of full-thickness RCT surgery not considered as the first treatment of choice willingness to sign the informed consent form. Exclusion Criteria: inflammatory rheumatic diseases history of fracture or operations around the shoulder region neurological diseases infections or tumours diabetes coagulation diseases intra-articular injections of the involved shoulder within the last 12 months.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycloergometer group<br>Training at home with the cycloergometer per 20 minutes twice a day. The protocol suggested a continous use of the cycloergometer for a period of 6 months after 2 weeks of rehabilitation as outpatient. | Other: Cycloergometer<br>* Daily training of the RCT patients was provided by the use of a cycloergometer at home. Educational support once a month was guaranteed by a nurse of the telemedicine service<br>|
| No Intervention: Control group<br>Usual care after a period (2 weeks) of rehabilitation as outpatient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Numeric Scale (VNS) | The scale evaluated shoulder pain during activity | Change from Baseline VNS at 6 months after the out-patient rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley scale | The scale evaluated shoulder functionality | Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation | 
| Health Assessment Questionnaire (HAQ) | The Questionnaire evaluated Disability | Change from Baseline HAQ at 6 months after the out-patient rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disability, pain, Rotator Cuff Tear, rehabilitation, range of motion (ROM)