Cycloergometer and Rotator Cuff Tear

October 7, 2016 updated by: Bernardo Gialanella, Fondazione Salvatore Maugeri

Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycloergometer group
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
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
No Intervention: Control group
Usual care after a period (2 weeks) of rehabilitation as outpatient.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Salvatore Maugeri

Investigators

  • Principal Investigator: Bernardo Gialanella, MD, Fondazione Salvatore Maugeri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cts 2012-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Scientific manuscript

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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