Rotator Cuff TearNCT02929433
Cycloergometer and Rotator Cuff Tear
A study testing Cycloergometer in people with Rotator Cuff Tear, run by Fondazione Salvatore Maugeri.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Cycloergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- positive imaging diagnosis of full-thickness RCT
- surgery not considered as the first treatment of choice
- willingness to sign the informed consent form.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Cycloergometer
- Keywords
- disability, pain, Rotator Cuff Tear, rehabilitation, range of motion (ROM)
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycloergometerOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cycloergometer group | Experimental | 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. Receives: Other: Cycloergometer |
| Control group | No intervention | Usual care after a period (2 weeks) of rehabilitation as outpatient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Numeric Scale (VNS)
The scale evaluated shoulder pain during activity
Measured: Change from Baseline VNS at 6 months after the out-patient rehabilitation
Secondary outcomes (2)
Constant-Murley scale
The scale evaluated shoulder functionality
Measured: Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation
Health Assessment Questionnaire (HAQ)
The Questionnaire evaluated Disability
Measured: Change from Baseline HAQ at 6 months after the out-patient rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernardo Gialanella, Fondazione Salvatore Maugeri
- Investigators
- Bernardo Gialanella, MD, Principal investigator, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929433
- Sponsor's protocol ID
- cts 2012-13
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Scientific manuscript
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer
- ClinicalTrials.gov ID
- NCT02929433
- Acronym / sponsor ID
- cts 2012-13
- Conditions
- Rotator Cuff Tear
- Keywords
- disability, pain, Rotator Cuff Tear, rehabilitation, range of motion (ROM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycloergometer group | Experimental | Other: CycloergometerTraining 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. |
| Control group | No intervention | –Usual care after a period (2 weeks) of rehabilitation as outpatient. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- positive imaging diagnosis of full-thickness RCT
- surgery not considered as the first treatment of choice
- willingness to sign the informed consent form.
Key exclusion criteria (7 listed)
- inflammatory rheumatic diseases
- history of fracture or operations around the shoulder region
- neurological diseases
- infections or tumours
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CycloergometerDaily 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 | Other | Cycloergometer group |
Primary outcome
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
2 secondary outcomes
Constant-Murley scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Individual participant dataSharing planned: Yes. Scientific manuscript
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Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
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Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernardo Gialanella, MD principal investigator
Fondazione Salvatore Maugeri
Questions about this trial
What is this clinical trial studying?
A study testing Cycloergometer in people with Rotator Cuff Tear, run by Fondazione Salvatore Maugeri.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Numeric Scale (VNS) (time frame: Change from Baseline VNS at 6 months after the out-patient rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.