Rotator Cuff Tears of the ShoulderPhase 1NCT07192302
Partial Rotator Cuff Injury Combined With Stiff Shoulder
A Phase 1 study testing Arthroscopy and Drugs administration in people with Rotator Cuff Tears of the Shoulder and Shoulder Adhesive Capsulitis, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tears of the Shoulder, Shoulder Adhesive Capsulitis, Shoulder Arthroscopy
- What is being tested?
- Arthroscopy and Drugs administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Symptomatic shoulder pain for >2 weeks.
- MRI-confirmed partial-thickness rotator cuff tear (>50% tendon thickness or >5mm in length).
- Concomitant shoulder stiffness, defined as passive range of motion loss of ≥25% in at least two planes (forward flexion, abduction, external rotation, or internal rotation) compared to the contralateral side.
- Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs).
Who cannot join
- Age< 18 or >80 years.
- Full-thickness rotator cuff tear.
- Previous surgery on the affected shoulder.
- Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto).
- Cervical radiculopathy as a primary cause of symptoms.
- Systemic inflammatory arthritis.
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- Neurologic disorder affecting the shoulder.
- Contraindications to surgery or general anesthesia.
- Inability to comply with the rehabilitation protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Treatment Strategy of Partial Rotator Cuff Injury in Stiff Shoulders
A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)
Read the detailed description
Objective: To compare the clinical and functional outcomes of early surgical intervention (arthroscopic debridement/repair and capsular release) versus an initial structured, supervised rehabilitation program with delayed surgery only for non-responders, in patients with PTRCT and shoulder stiffness.
Methods: This will be a single-center, prospective, randomized, controlled, parallel-group trial. patients will be randomized (1:1) to either:
Group A (Early Surgery): Arthroscopic surgery within 6 weeks of randomization.
Group B (Rehabilitation-First): A 6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.
Primary outcome will be the change in the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score from baseline to 12 months. Secondary outcomes include pain (VAS), range of motion (ROM), Constant-Murley Score, Single Assessment Numeric Evaluation (SANE), and rates of conversion to surgery. Outcomes will be assessed at baseline 6 months and 6 months after surgery.
Expected Outcomes: The investigators hypothesize that the early surgery group will demonstrate faster initial improvement in pain and function. However, the investigators anticipate that by 6 months, a significant proportion of the rehabilitation-first group will avoid surgery altogether and achieve non-inferior, if not equivalent, outcomes compared to the early surgery group.
- Being tested
- Arthroscopy, Drugs administration
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroscopyProcedure or surgery
Early Surgical Intervention in Patients with Partial Rotator Cuff Tears and Concomitant Shoulder Stiffness.
Drugs administrationDrug
Oral Medication for Conservative Management of Partial Rotator Cuff Tears with Concomitant Shoulder Stiffness.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Early Surgery) | Experimental | : Arthroscopic surgery within 6 weeks Receives: Procedure: Arthroscopy |
| Group B (Rehabilitation-First) | Sham comparator | 6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery. Receives: Drug: Drugs administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index （SPADI）
Shoulder Pain and Disability Index （SPADI） from 0-100. The lower the number, the better the functional outcomes of the patients.
Measured: 6 month before surgery and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tears of the ShoulderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192302
- Sponsor's protocol ID
- GJL20250831
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2025
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Treatment Strategy of Partial Rotator Cuff Injury in Stiff Shoulders
- ClinicalTrials.gov ID
- NCT07192302
- Acronym / sponsor ID
- GJL20250831
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)
Detailed description
Objective: To compare the clinical and functional outcomes of early surgical intervention (arthroscopic debridement/repair and capsular release) versus an initial structured, supervised rehabilitation program with delayed surgery only for non-responders, in patients with PTRCT and shoulder stiffness.
Methods: This will be a single-center, prospective, randomized, controlled, parallel-group trial. patients will be randomized (1:1) to either:
Group A (Early Surgery): Arthroscopic surgery within 6 weeks of randomization.
Group B (Rehabilitation-First): A 6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery.
Primary outcome will be the change in the American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score from baseline to 12 months. Secondary outcomes include pain (VAS), range of motion (ROM), Constant-Murley Score, Single Assessment Numeric Evaluation (SANE), and rates of conversion to surgery. Outcomes will be assessed at baseline 6 months and 6 months after surgery.
Expected Outcomes: The investigators hypothesize that the early surgery group will demonstrate faster initial improvement in pain and function. However, the investigators anticipate that by 6 months, a significant proportion of the rehabilitation-first group will avoid surgery altogether and achieve non-inferior, if not equivalent, outcomes compared to the early surgery group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Early Surgery) | Experimental | Procedure: Arthroscopy: Arthroscopic surgery within 6 weeks |
| Group B (Rehabilitation-First) | Sham comparator | Drug: Drugs administration6-month structured physical therapy program. Patients who do not achieve a pre-defined successful outcome at 6 months will then undergo delayed surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years.
- Symptomatic shoulder pain for >2 weeks.
- MRI-confirmed partial-thickness rotator cuff tear (>50% tendon thickness or >5mm in length).
- Concomitant shoulder stiffness, defined as passive range of motion loss of ≥25% in at least two planes (forward flexion, abduction, external rotation, or internal rotation) compared to the contralateral side.
- Failure of a brief (≥2 weeks) trial of conservative care (e.g., oral NSAIDs).
Key exclusion criteria (9 listed)
- Age< 18 or >80 years.
- Full-thickness rotator cuff tear.
- Previous surgery on the affected shoulder.
- Glenohumeral osteoarthritis (Grade ≥2 Samilson-Prieto).
- Cervical radiculopathy as a primary cause of symptoms.
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 |
|---|---|---|
| ArthroscopyEarly Surgical Intervention in Patients with Partial Rotator Cuff Tears and Concomitant Shoulder Stiffness. | Procedure or surgery | Group A (Early Surgery) |
| Drugs administrationOral Medication for Conservative Management of Partial Rotator Cuff Tears with Concomitant Shoulder Stiffness. | Drug | Group B (Rehabilitation-First) |
Primary outcome
Shoulder Pain and Disability Index （SPADI）
Time frame: 6 month before surgery and 6 months after surgery
Shoulder Pain and Disability Index （SPADI） from 0-100. The lower the number, the better the functional outcomes of the patients.
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 16 Jan 2026.
- 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?
A Phase 1 study testing Arthroscopy and Drugs administration in people with Rotator Cuff Tears of the Shoulder and Shoulder Adhesive Capsulitis, run by Hebei Medical 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Shoulder Pain and Disability Index （SPADI） (time frame: 6 month before surgery and 6 months after surgery). 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 Jan 2026.