Rotator Cuff TearsEarly Phase 1NCT05852093
Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
A Early Phase 1 study testing Celecoxib+Buprenorphine Transdermal Patch and Celecoxib+Buprenorphine Transdermal Patch+Tizanidine in people with Rotator Cuff Tears, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy; Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Celecoxib+Buprenorphine Transdermal Patch and Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Patients who were diagnosed as supraspinatus tendon and infraspinatus tendon tear and underwent shoulder arthroscopic surgery in the Second Affiliated Hospital of Zhejiang University; 2 Age 20~70 years old; 3 Those with a long medical history, and symptoms such as shoulder joint pain and weakness in a short period of time are obviously aggravated; 4. After 3 months of medication and physical therapy, the symptoms and functions have not improved significantly; 5 Volunteer to participate in this study, and the person and his/her family members have given informed consent to the content of this study and signed the consent form
Who cannot join
- Patients with simple frozen shoulder;
- Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;
- 4 Patients with subscapularis tendon tear, long head tendinopathy requiring surgical treatment, and severe shoulder synovitis were found during the operation; 5 Patients with upper limb nerve injury, shoulder fracture, bone defect or severe osteoporosis; 6. Patients with serious organ or hematopoietic system and other primary diseases; 7. Those who are allergic to the drugs used in this study; 8 Women who are breast-feeding, pregnant or preparing to become pregnant; 9 Patients with language and communication disorders, mental history, cognitive dysfunction, etc. who cannot cooperate with the completion of nursing intervention and research, and cannot complete the questionnaire required for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;
- Conditions
- Rotator Cuff Tears
- Being tested
- Celecoxib+Buprenorphine Transdermal Patch, Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
- 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.
Celecoxib+Buprenorphine Transdermal PatchDrug
NSAIDs+narcotic analgesics
Celecoxib+Buprenorphine Transdermal Patch+TizanidineDrug
NSAIDs+narcotic analgesics+Skeletal Muscle Relaxant
| Study group | Role | What they receive |
|---|---|---|
| Drug: Celecoxib+Buprenorphine Transdermal Patch | Active comparator | Not described Receives: Drug: Celecoxib+Buprenorphine Transdermal Patch |
| Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine | Experimental | Not described Receives: Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index；PSQI
Measured: From Week 0 (baseline) to Week24
Secondary outcomes (4)
American Shoulder and Elbow Surgeons Score; ASES
Measured: From Week 0 (baseline) to Week24
UCLA score; UCLA
Measured: From Week 0 (baseline) to Week24
Visual Analogu Scale; VAS
Measured: From Week 0 (baseline) to Week24
Oxford Shoulder Score; OSS
Measured: From Week 0 (baseline) to Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YangGuang, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852093
- Sponsor's protocol ID
- 研2023-0251
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT05852093
- Acronym / sponsor ID
- 研2023-0251
- Conditions
- Rotator Cuff Tears
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 May 2023 (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.
The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Celecoxib+Buprenorphine Transdermal Patch | Active comparator | Drug: Celecoxib+Buprenorphine Transdermal Patch |
| Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine | Experimental | Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 Patients who were diagnosed as supraspinatus tendon and infraspinatus tendon tear and underwent shoulder arthroscopic surgery in the Second Affiliated Hospital of Zhejiang University; 2 Age 20~70 years old; 3 Those with a long medical history, and symptoms such as shoulder joint pain and weakness in a short period of time are obviously aggravated; 4. After 3 months of medication and physical therapy, the symptoms and functions have not improved significantly; 5 Volunteer to participate in this study, and the person and his/her family members have given informed consent to the content of this study and signed the consent form
Key exclusion criteria (3 listed)
- Patients with simple frozen shoulder;
- Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;
- 4 Patients with subscapularis tendon tear, long head tendinopathy requiring surgical treatment, and severe shoulder synovitis were found during the operation; 5 Patients with upper limb nerve injury, shoulder fracture, bone defect or severe osteoporosis; 6. Patients with serious organ or hematopoietic system and other primary diseases; 7. Those who are allergic to the drugs used in this study; 8 Women who are breast-feeding, pregnant or preparing to become pregnant; 9 Patients with language and communication disorders, mental history, cognitive dysfunction, etc. who cannot cooperate with the completion of nursing intervention and research, and cannot complete the questionnaire required for this study.
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 |
|---|---|---|
| Celecoxib+Buprenorphine Transdermal PatchNSAIDs+narcotic analgesics | Drug | Drug: Celecoxib+Buprenorphine Transdermal Patch |
| Celecoxib+Buprenorphine Transdermal Patch+TizanidineNSAIDs+narcotic analgesics+Skeletal Muscle Relaxant | Drug | Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine |
Primary outcome
Pittsburgh sleep quality index；PSQI
Time frame: From Week 0 (baseline) to Week24
4 secondary outcomes
American Shoulder and Elbow Surgeons Score; ASES
Time frame: From Week 0 (baseline) to Week24
UCLA score; UCLA
Time frame: From Week 0 (baseline) to Week24
Visual Analogu Scale; VAS
Time frame: From Week 0 (baseline) to Week24
Oxford Shoulder Score; OSS
Time frame: From Week 0 (baseline) to Week24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Yes
Related trials for Rotator Cuff Tears
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Celecoxib+Buprenorphine Transdermal Patch and Celecoxib+Buprenorphine Transdermal Patch+Tizanidine in people with Rotator Cuff Tears, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 3 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: opening soon, as of the sponsor's last update on 10 May 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guang Yang (13738097781, 2316426@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index；PSQI (time frame: From Week 0 (baseline) to Week24). 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 10 May 2023.