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Effects of Ultrasound Intervention on Clinical Outcomes and Tear Progression in Patients with Non-operative Rotator Cuff Tears: A Randomized Controlled Trial

Effects of Ultrasound Intervention on Clinical Outcomes and Tear Progression in Patients with Non-operative Rotator Cuff Tears: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127809
Enrollment
Unknown
Registered
2026-07-08
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff tear (partial / complete)

Interventions

Control group:In-hospital rehabilitation training only
Experimental group:In-hospital rehabilitation training + Low-Intensity Pulsed Ultrasound (LIPUS)

Sponsors

Shanghai Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age and gender: Between 18 and 75 years old (inclusive), any gender; 2. Clinical diagnosis: Diagnosed with a rotator cuff tear through clinical symptoms, physical examination (such as Neer sign, Hawkins sign, Jobe test, etc.), and imaging (MRI or ultrasound); 3. Non-surgical indications: Assessed by orthopedic/sports medicine specialists and confirmed that conservative treatment is currently appropriate and there are no surgical indications, specifically: (1) Full-thickness tears with a diameter =3, and functional impairment lasting more than 1 month; 5. Compliance: Patients can understand and cooperate with the ultrasound treatment plan and follow-up assessments; 6. Informed consent: Willing to participate in this study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe structural degeneration of the rotator cuff muscles: rotator cuff fatty infiltration Goutallier grade >=3, or with severe muscle atrophy (muscle belly thickness reduced >50% compared to the other side); 2. Combined with other shoulder conditions: such as frozen shoulder (adhesive capsulitis), biceps long head tendonitis, or shoulder instability (habitual dislocation); 3. Surgical history: previous surgery or fracture on the affected shoulder; 4. Contraindications for ultrasound therapy: (1) Open wounds, local infection, malignant tumors, or skin diseases in the treatment area; (2) Presence of implanted pacemaker or other electronic devices; (3) Coagulation disorders, etc.; 5. Recent targeted interventions: received glucocorticoid injection, PRP therapy, extracorporeal shock wave, or other targeted interventions within the past month; 6. Systemic diseases: severe heart, liver, or kidney dysfunction, diabetes (HbA1c >7.0%), autoimmune diseases, or mental disorders that may affect soft tissue healing; 7. Neurological disorders: severe cervical spondylosis causing referred shoulder pain, or nerve paralysis on the affected limb (e.g., axillary nerve injury); 8. Special physiological conditions: women who are pregnant or breastfeeding; 9. Research conflicts: currently participating in other clinical trials; 10. Others: any other situations deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Constant-Murley Shoulder Function Score;Adverse event incidence;

Secondary

MeasureTime frame
Visual Analog Scale (VAS) for pain;Healing Status of the Rotator Cuff Tendons;Supraspinatus muscle atrophy;Shoulder muscle strength;Treatment adherence;Oxford Shoulder Score (OSS);Global fatty degeneration index (GFDI);Tendon thickness, SNQ, blood flow, synovial thickness;Global Perception of Improvement Scale (GPIS);Shoulder range of motion (ROM);

Countries

China

Contacts

Public ContactJiang Jia

Shanghai Sixth People’s Hospital

jessicajj19@sjtu.edu.cn+86 21 64369181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026