Rotator Cuff InjuriesPRP+CB for RCNCT07348016
Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic Surgery for Rotator Cuff Injury With Shoulder Adhesion: A Prospective, Multicenter, Randomized Controlled Trial
A study testing Liposomal Bupivacaine + Compound Betamethasone Injection and Compound Betamethasone Injection in people with Rotator Cuff Injuries and Adhesions, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries, Adhesions
- What is being tested?
- Liposomal Bupivacaine + Compound Betamethasone Injection and Compound Betamethasone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Dec 2028
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Clinical and MRI diagnosis of full-thickness rotator cuff tear.
- Presence of shoulder stiffness/adhesion defined as passive range of motion less than 100° in forward flexion and/or less than 10° in external rotation (or according to your specific definition).
- Scheduled for arthroscopic rotator cuff repair and capsular release.
- Willing and able to provide written informed consent.
- Willing to comply with all study procedures and follow-up visits.
Who cannot join
- Massive, irreparable rotator cuff tear.
- Severe glenohumeral osteoarthritis (Grade III or IV according to Samilson-Prieto classification).
- History of shoulder infection, fracture, or previous surgery on the affected shoulder.
- Known allergy or contraindication to betamethasone, local anesthetics, or components of PRP preparation.
- Systemic inflammatory arthritis (e.g., rheumatoid arthritis).
- Coagulation disorders or use of anticoagulants that cannot be safely suspended perioperatively.
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- Pregnancy or lactation.
- Participation in another clinical trial within the past 3 months.
- Any medical or psychiatric condition that, in the investigator's opinion, would compromise patient safety or compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Hao Liang, MD, 13607008562, haoliang201@163.com
About this study
Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound Betamethasone) during surgery can improve outcomes.
Methods: This is a prospective, randomized, double-blind, controlled trial. Approximately 70 eligible adult patients will be randomly assigned to one of two groups: (1) the Combination Group, receiving an intra-articular injection of Liposomal Bupivacaine plus Compound Betamethasone after surgery, or (2) the Control Group, receiving Compound Betamethasone alone. Patients and outcome assessors will not know the group assignment.
Read more
What participants will do: All participants will receive standard arthroscopic rotator cuff repair and adhesion release. They will be followed for 12 months after surgery, with assessments at multiple time points (from hours to months post-op) to measure pain levels, shoulder function, range of motion, and tendon healing via MRI.
Main Goals: The primary goal is to compare the improvement in UCLA shoulder scores between the two groups at 12 months. Secondary goals include comparing pain scores, other functional scores (Constant-Murley), joint mobility, MRI findings, and safety (complication rates).
Read the detailed description
Study Design: A prospective, randomized, double-blind, parallel-group, active-controlled clinical trial conducted at The Second Affiliated Hospital of Nanchang University.
Participants \& Sample Size: 70 patients (35 per group) with full-thickness rotator cuff tear and concomitant shoulder adhesion scheduled for arthroscopic repair. Sample size was calculated based on an expected difference in UCLA scores with 80% power and α=0.05, accounting for a 20% dropout rate.
Interventions:
Combination Therapy Group: After standard arthroscopic rotator cuff repair and capsular release, the shoulder joint will be injected with a mixture of Liposomal Bupivacaine and Compound Betamethasone under direct visualization.
Active Control Group: After the same surgical procedure, the joint will be injected with Compound Betamethasone alone.
Outcome Measures:
Primary: UCLA Shoulder Score (assessed pre-op, 3, 6, 12 months).
Secondary: Visual Analog Scale (VAS) for pain (assessed at 11 time points from pre-op to 12 months), Constant-Murley Shoulder Score, active range of motion (forward flexion, abduction), MRI evaluation of tendon healing using Signal-to-Noise Quotient (SNQ) of the supraspinatus tendon (distal and proximal), and incidence of complications (infection, re-tear, thrombosis, adhesion) within 12 months.
Statistics: Data will be analyzed using SPSS. Continuous variables will be compared using t-tests or non-parametric tests as appropriate. Categorical variables will be compared using Chi-square tests. A p-value <0.05 will be considered statistically significant.
Ethics \& Registration: The study protocol will be submitted for approval to the Institutional Review Board of The Second Affiliated Hospital of Nanchang University. It will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. This trial is registered on ClinicalTrials.gov.
Funding: Supported by the Internal Grant Program of The Second Affiliated Hospital of Nanchang University.
- Conditions
- Rotator Cuff Injuries, Adhesions
- Being tested
- Liposomal Bupivacaine + Compound Betamethasone Injection, Compound Betamethasone Injection
- Keywords
- Platelet-Rich Plasma, Compound Betamethasone, Arthroscopy, Randomized Controlled Trial, Shoulder, Stiffness
- Medical subject headings
- Rotator Cuff Injuries, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine + Compound Betamethasone InjectionDrug
Intra-articular injection of a mixture containing Liposomal Bupivacaine and Compound Betamethasone under arthroscopic guidance after standard surgical procedures.
Compound Betamethasone InjectionDrug
Intra-articular injection of Compound Betamethasone alone under arthroscopic guidance after standard surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Experimental | Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Liposomal Bupivacaine combined with Compound Betamethasone. Receives: Drug: Liposomal Bupivacaine + Compound Betamethasone Injection |
| Monotherapy (Control) Group | Active comparator | Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Compound Betamethasone alone. Receives: Drug: Compound Betamethasone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant-Murley Shoulder Score
The Constant-Murley score is a composite outcome measure assessing shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better function.
Measured: Baseline, 3 months, and 12 months postoperatively.
Visual Analog Scale (VAS) Pain Score at Rest
Pain intensity at rest measured on a 100-mm Visual Analog Scale, where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable."
Measured: Baseline, 3 months, and 12 months postoperatively.
Secondary outcomes (4)
Active Range of Motion (ROM)
Measured in degrees for shoulder forward flexion, abduction, and external rotation using a goniometer
Measured: Baseline, 3 months, and 12 months postoperatively.
American Shoulder and Elbow Surgeons (ASES) Score
A patient-reported outcome measure assessing pain and functional activities. Scores range from 0 to 100, with higher scores indicating better function.
Measured: Baseline, 3 months, and 12 months postoperatively.
MRI Assessment of Tendon Healing
MRI Assessment of Tendon Healing
Measured: 3 months and 12 months postoperatively.
Incidence of Treatment-Related Adverse Events
Number and severity of adverse events (e.g., infection, allergic reaction, abnormal bleeding, systemic effects) assessed as related to the study interventions (PRP and/or betamethasone injection).
Measured: From the time of surgery up to 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Aug 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion1 Dec 2028 (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 of Nanchang UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348016
- Sponsor's protocol ID
- EFY-2025-085
- Other IDs
- EFY-2025-085
- Acronym
- PRP+CB for RC
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 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
- Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic Surgery for Rotator Cuff Injury With Shoulder Adhesion: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07348016
- Acronym / sponsor ID
- PRP+CB for RC / EFY-2025-085
- Conditions
- Rotator Cuff Injuries, Adhesions
- Keywords
- Platelet-Rich Plasma, Compound Betamethasone, Arthroscopy, Randomized Controlled Trial, Shoulder, Stiffness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (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.
Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound Betamethasone) during surgery can improve outcomes.
Methods: This is a prospective, randomized, double-blind, controlled trial. Approximately 70 eligible adult patients will be randomly assigned to one of two groups: (1) the Combination Group, receiving an intra-articular injection of Liposomal Bupivacaine plus Compound Betamethasone after surgery, or (2) the Control Group, receiving Compound Betamethasone alone. Patients and outcome assessors will not know the group assignment.
What participants will do: All participants will receive standard arthroscopic rotator cuff repair and adhesion release. They will be followed for 12 months after surgery, with assessments at multiple time points (from hours to months post-op) to measure pain levels, shoulder function, range of motion, and tendon healing via MRI.
Main Goals: The primary goal is to compare the improvement in UCLA shoulder scores between the two groups at 12 months. Secondary goals include comparing pain scores, other functional scores (Constant-Murley), joint mobility, MRI findings, and safety (complication rates).
Detailed description
Study Design: A prospective, randomized, double-blind, parallel-group, active-controlled clinical trial conducted at The Second Affiliated Hospital of Nanchang University.
Participants \& Sample Size: 70 patients (35 per group) with full-thickness rotator cuff tear and concomitant shoulder adhesion scheduled for arthroscopic repair. Sample size was calculated based on an expected difference in UCLA scores with 80% power and α=0.05, accounting for a 20% dropout rate.
Interventions:
Combination Therapy Group: After standard arthroscopic rotator cuff repair and capsular release, the shoulder joint will be injected with a mixture of Liposomal Bupivacaine and Compound Betamethasone under direct visualization.
Active Control Group: After the same surgical procedure, the joint will be injected with Compound Betamethasone alone.
Outcome Measures:
Primary: UCLA Shoulder Score (assessed pre-op, 3, 6, 12 months).
Secondary: Visual Analog Scale (VAS) for pain (assessed at 11 time points from pre-op to 12 months), Constant-Murley Shoulder Score, active range of motion (forward flexion, abduction), MRI evaluation of tendon healing using Signal-to-Noise Quotient (SNQ) of the supraspinatus tendon (distal and proximal), and incidence of complications (infection, re-tear, thrombosis, adhesion) within 12 months.
Statistics: Data will be analyzed using SPSS. Continuous variables will be compared using t-tests or non-parametric tests as appropriate. Categorical variables will be compared using Chi-square tests. A p-value <0.05 will be considered statistically significant.
Ethics \& Registration: The study protocol will be submitted for approval to the Institutional Review Board of The Second Affiliated Hospital of Nanchang University. It will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. This trial is registered on ClinicalTrials.gov.
Funding: Supported by the Internal Grant Program of The Second Affiliated Hospital of Nanchang University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Drug: Liposomal Bupivacaine + Compound Betamethasone InjectionParticipants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Liposomal Bupivacaine combined with Compound Betamethasone. |
| Monotherapy (Control) Group | Active comparator | Drug: Compound Betamethasone InjectionParticipants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Compound Betamethasone alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years.
- Clinical and MRI diagnosis of full-thickness rotator cuff tear.
- Presence of shoulder stiffness/adhesion defined as passive range of motion less than 100° in forward flexion and/or less than 10° in external rotation (or according to your specific definition).
- Scheduled for arthroscopic rotator cuff repair and capsular release.
- Willing and able to provide written informed consent.
Key exclusion criteria (9 listed)
- Massive, irreparable rotator cuff tear.
- Severe glenohumeral osteoarthritis (Grade III or IV according to Samilson-Prieto classification).
- History of shoulder infection, fracture, or previous surgery on the affected shoulder.
- Known allergy or contraindication to betamethasone, local anesthetics, or components of PRP preparation.
- Systemic inflammatory arthritis (e.g., rheumatoid arthritis).
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 |
|---|---|---|
| Liposomal Bupivacaine + Compound Betamethasone InjectionIntra-articular injection of a mixture containing Liposomal Bupivacaine and Compound Betamethasone under arthroscopic guidance after standard surgical procedures. | Drug | Combination Therapy Group |
| Compound Betamethasone InjectionIntra-articular injection of Compound Betamethasone alone under arthroscopic guidance after standard surgical procedures. | Drug | Monotherapy (Control) Group |
Primary outcome
Change in Constant-Murley Shoulder Score
Time frame: Baseline, 3 months, and 12 months postoperatively.
The Constant-Murley score is a composite outcome measure assessing shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better function.
Visual Analog Scale (VAS) Pain Score at Rest
Time frame: Baseline, 3 months, and 12 months postoperatively.
Pain intensity at rest measured on a 100-mm Visual Analog Scale, where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable."
4 secondary outcomes
Active Range of Motion (ROM)
Time frame: Baseline, 3 months, and 12 months postoperatively.
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, 3 months, and 12 months postoperatively.
MRI Assessment of Tendon Healing
Time frame: 3 months and 12 months postoperatively.
Incidence of Treatment-Related Adverse Events
Time frame: From the time of surgery up to 12 months postoperatively.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Bupivacaine + Compound Betamethasone Injection and Compound Betamethasone Injection in people with Rotator Cuff Injuries and Adhesions, run by Second Affiliated Hospital of Nanchang University 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 6 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: looking for participants now, 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. 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?
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 Hao Liang, MD (+86-13607008562, haoliang201@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constant-Murley Shoulder Score (time frame: Baseline, 3 months, and 12 months postoperatively.). The study lists 2 primary outcomes in all. 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.