Tennis ElbowNCT04457024
Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear
An observational study of Tennis Elbow and MRI, run by Peking University Third Hospital at 1 site in China.
Trial summary
To explore whether there is a difference in the rate of tendon tear after hyperlipemia in tennis elbow patients and those with normal blood lipids after closed treatment, which provides clues for further exploration of its mechanism. 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tennis Elbow, MRI, Hyperlipidemia
- What is being tested?
- classification statistics
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Apr 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: In order to rule out the influence of the imbalance between height and weight on blood lipids, the difference between the case group and the control group was analyzed after adjusting the height and weight covariates using the Generalized Linear Model.
Who may be able to join
- All patients with tennis elbows in our hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univerisity Third Hospital
Beijing, Beijing Municipality, 100191
About this study
To explore whether there is a difference in the rate of tendon tear after hyperlipemia in tennis elbow patients and those with normal blood lipids after closed treatment, which provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking University Third Hospital. Statistics included the sex, age, BMI, number of closures, total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the humerus to see if there is a tear as an observation indicator. Analyze the difference of tendon tear after closed treatment in patients with high blood fat and normal blood fat.
- Conditions
- Tennis Elbow, MRI, Hyperlipidemia
- Being tested
- classification statistics
- Medical subject headings
- Tennis Elbow, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classification statisticsOther
Without any intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Use MRI to assess whether the tendon is torn
One sports medicine surgeon and one musculoskeletal radiologists, being blinded to the patients' information, reviewed the elbow MRI independently. The common extensor tendon (CET) abnormalities were evaluated on axial and coronal fat-suppressed T2-weighted FSE image. Tendinosis group was defined as an increased signal intensity, but lower than the fluid signal on T2-weighted images and/ or an increased tendon thickness. Tendon tear group contain a partial thickness tear defined as a region with fluid-signal-intensity that extended partway across the tendon and a full thickness tear appeared as a gap of fluid-signal-intensity across the entire tendon substance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jan 2020
- Primary completion20 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 108 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457024
- Sponsor's protocol ID
- M2019143
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear
- ClinicalTrials.gov ID
- NCT04457024
- Acronym / sponsor ID
- M2019143
- Conditions
- Tennis Elbow, MRI, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 7 Jul 2020 (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.
To explore whether there is a difference in the rate of tendon tear after hyperlipemia in tennis elbow patients and those with normal blood lipids after closed treatment, which provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking University Third Hospital. Statistics included the sex, age, BMI, number of closures, total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the humerus to see if there is a tear as an observation indicator. Analyze the difference of tendon tear after closed treatment in patients with high blood fat and normal blood fat.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In order to rule out the influence of the imbalance between height and weight on blood lipids, the difference between the case group and the control group was analyzed after adjusting the height and weight covariates using the Generalized Linear Model.
Key inclusion criteria (1 listed)
- All patients with tennis elbows in our hospital
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| classification statisticsWithout any intervention | Other | – |
Primary outcome
Use MRI to assess whether the tendon is torn
Time frame: 3 months
One sports medicine surgeon and one musculoskeletal radiologists, being blinded to the patients' information, reviewed the elbow MRI independently. The common extensor tendon (CET) abnormalities were evaluated on axial and coronal fat-suppressed T2-weighted FSE image. Tendinosis group was defined as an increased signal intensity, but lower than the fluid signal on T2-weighted images and/ or an increased tendon thickness. Tendon tear group contain a partial thickness tear defined as a region with fluid-signal-intensity that extended partway across the tendon and a full thickness tear appeared as a gap of fluid-signal-intensity across the entire tendon substance.
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 7 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tennis Elbow and MRI, run by Peking University Third Hospital 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 1 inclusion and 1 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 7 Jul 2020. 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?
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?
Use MRI to assess whether the tendon is torn (time frame: 3 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 7 Jul 2020.