Cycloergometer and Rotator Cuff Tear

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Other: Cycloergometer

• Registration Number: NCT02929433
• Lead Sponsor: Fondazione Salvatore Maugeri

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Study First Submitted: 2016-09-28
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycloergometer group	Cycloergometer	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.

Primary Outcome Measures

Name	Time	Method
Visual Numeric Scale (VNS)	Change from Baseline VNS at 6 months after the out-patient rehabilitation	The scale evaluated shoulder pain during activity

Secondary Outcome Measures

Name	Time	Method
Health Assessment Questionnaire (HAQ)	Change from Baseline HAQ at 6 months after the out-patient rehabilitation	The Questionnaire evaluated Disability
Constant-Murley scale	Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation	The scale evaluated shoulder functionality