Cycloergometer and Rotator Cuff Tear

Fondazione Salvatore Maugeri

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Other: Cycloergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT02929433

cts 2012-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Cycloergometer group

Experimental group

Description:

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.

Treatment:

Other: Cycloergometer

Control group

No Intervention group

Description:

Usual care after a period (2 weeks) of rehabilitation as outpatient.