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Cycloergometer and Rotator Cuff Tear

Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929433
Enrollment
38
Registered
2016-10-11
Start date
2013-01-31
Completion date
2015-06-30
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

Keywords

disability, pain, Rotator Cuff Tear, rehabilitation, range of motion (ROM)

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.

Interventions

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

Sponsors

Fondazione Salvatore Maugeri
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Numeric Scale (VNS)Change from Baseline VNS at 6 months after the out-patient rehabilitationThe scale evaluated shoulder pain during activity

Secondary

MeasureTime frameDescription
Constant-Murley scaleChange from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitationThe scale evaluated shoulder functionality
Health Assessment Questionnaire (HAQ)Change from Baseline HAQ at 6 months after the out-patient rehabilitationThe Questionnaire evaluated Disability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026