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Investigating the Effectiveness of Botulinum Toxin A Injections for Supraspinatus Tendinopathy

Safety and Efficacy of Botulinum Toxin A Injection on Pain Intensity, Quality of Life, Grip Strength, and Range of Motion in Patients with Supraspinatus Tendinopathy Compared to the Control Group: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240729062578N1
Enrollment
40
Registered
2024-09-01
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Supraspinatus tendinopathy. Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder

Interventions

Intervention 1: Intervention group: 30 units of 500 units of Botox Dysport, one time, will be injected into the supraspinatus muscle by a physical medicine specialist using a 22-gauge needle and guide

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Symptoms of supraspinatus tendinopathy in examination and ultrasound after at least 6 months of symptoms Patients who aged > 20 , < 70 years old

Exclusion criteria

Exclusion criteria: History of hand or shoulder trauma History of hand or shoulder surgery History of sensitivity to BTX Absence of cervical radiculopathy History of frozen shoulder Complete rupture of the supraspinatus tendon (based on clinical examinations and paraclinical investigations) Lack of patient consent to enter the study pregnancy Having a severe underlying disease such as uncontrolled diabetes Autoimmune and platelet disorders, treatment with anticoagulant and antiplatelet drugs within 10 days before injection

Design outcomes

Primary

MeasureTime frame
Pain intensity. Timepoint: 1and3 months later. Method of measurement: VAS score.;Range of motion. Timepoint: 1and3 months later. Method of measurement: Goniometer.;Grip strenght. Timepoint: 1and3months later. Method of measurement: Dynamometer.;Quality of life. Timepoint: 1and 3 months later. Method of measurement: WHO QOL BREF questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboobe ghanbarian

Shahid Beheshti University of Medical Sciences

mahboobeghanbarian313@gmail.com+98 21 2271 8000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026