Rotator Cuff InjuriesNCT04927507
Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing
A study testing Internet plus nursing home rehabilitation in people with Rotator Cuff Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Rotator cuff injury patients treated with ERAS were included. The control group was given routine nursing. The observation group was given the Internet plus nursing home rehabilitation mode. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Internet plus nursing home rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator cuff injury
- ERAS surgery treatment
- Full thickness tear of rotator cuff, The range of tear is 1cm-3cm
Who cannot join
- Surgery not applicable
- Combined with other injuries, malignant tumor, disabilities, mental illness, critically ill patients, pregnant women, illiteracy, minors, cognitive impairment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ping Qian
Hangzhou
Ping Qian, 057187783777, 13208118@qq.com
About this study
Rotator cuff injury patients treated with ERAS were included. The control group was given routine nursing. The observation group was given the Internet plus nursing home rehabilitation mode.
Relying on mobile app and wechat, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Internet plus nursing home rehabilitation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet plus nursing home rehabilitationBehavioural
The observation group was given the Internet plus nursing home rehabilitation mode.
Relying on mobile app and wechat public service platform, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group was given routine nursing. |
| Observation group | Experimental | The observation group was given the Internet plus nursing home rehabilitation mode. Receives: Behavioral: Internet plus nursing home rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Constant-Murley score
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The best situation is 100 points. The worst situation is 0 points.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927507
- Sponsor's protocol ID
- 2021-0061
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing
- ClinicalTrials.gov ID
- NCT04927507
- Acronym / sponsor ID
- 2021-0061
- Conditions
- Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Jun 2021 (actual)
- 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.
Rotator cuff injury patients treated with ERAS were included. The control group was given routine nursing. The observation group was given the Internet plus nursing home rehabilitation mode.
Relying on mobile app and wechat, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group was given routine nursing. |
| Observation group | Experimental | Behavioral: Internet plus nursing home rehabilitationThe observation group was given the Internet plus nursing home rehabilitation mode. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rotator cuff injury
- ERAS surgery treatment
- Full thickness tear of rotator cuff, The range of tear is 1cm-3cm
Key exclusion criteria (2 listed)
- Surgery not applicable
- Combined with other injuries, malignant tumor, disabilities, mental illness, critically ill patients, pregnant women, illiteracy, minors, cognitive impairment
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 |
|---|---|---|
| Internet plus nursing home rehabilitationThe observation group was given the Internet plus nursing home rehabilitation mode. Relying on mobile app and wechat public service platform, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time. | Behavioural | Observation group |
Primary outcome
The Constant-Murley score
Time frame: up to 6 months
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The best situation is 100 points. The worst situation is 0 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet plus nursing home rehabilitation in people with Rotator Cuff Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Qian (0571-87783777, 13208118@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Constant-Murley score (time frame: up to 6 months). 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 16 Jun 2021.