Back to resultsCycloergometer and Rotator Cuff Tear
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cycloergometer
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring disability, pain, Rotator Cuff Tear, rehabilitation, range of motion (ROM)
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cycloergometer group
Control group
Arm 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.
Usual care after a period (2 weeks) of rehabilitation as outpatient.
Outcomes
Primary Outcome Measures
Visual Numeric Scale (VNS)
The scale evaluated shoulder pain during activity
Secondary Outcome Measures
Constant-Murley scale
The scale evaluated shoulder functionality
Health Assessment Questionnaire (HAQ)
The Questionnaire evaluated Disability
Full Information
NCT ID
NCT02929433
First Posted
September 28, 2016
Last Updated
October 7, 2016
Sponsor
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT02929433
Brief Title
Cycloergometer and Rotator Cuff Tear
Official Title
Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
disability, pain, Rotator Cuff Tear, rehabilitation, range of motion (ROM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycloergometer group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care after a period (2 weeks) of rehabilitation as outpatient.
Intervention Type
Other
Intervention Name(s)
Cycloergometer
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Numeric Scale (VNS)
Description
The scale evaluated shoulder pain during activity
Time Frame
Change from Baseline VNS at 6 months after the out-patient rehabilitation
Secondary Outcome Measure Information:
Title
Constant-Murley scale
Description
The scale evaluated shoulder functionality
Time Frame
Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation
Title
Health Assessment Questionnaire (HAQ)
Description
The Questionnaire evaluated Disability
Time Frame
Change from Baseline HAQ at 6 months after the out-patient rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardo Gialanella, MD
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Scientific manuscript
Learn more about this trial
Cycloergometer and Rotator Cuff Tear
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