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Safety and effectiveness of Botox injections combined with cortisone in shoulder tendon problems

comparison of the safety and efficacy of botulinum toxin A injection combined with corticosteroids with corticosteroids with palcebo in the treatment of patients with supraspinatus tendinopathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240729062578N2
Enrollment
20
Registered
2026-01-27
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Supraspinatus tendinopathy. Shoulder lesion, unspecified

Interventions

Intervention 1: Intervention group: One injection of 30 units of Dysport into the supraspinatus muscle and 40 mg of methylprednisolone into the bursa of the supraspinatus tendon sheath once. Intervent

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with supraspinatus tendinopathy Confirmation of the problem by examination and ultrasound Not having previously received treatment Intervention should be carried out as a first line Age between 20-70 years

Exclusion criteria

Exclusion criteria: History of trauma to the hand and shoulder area in the last 6 months History of humerus fracture Complete rupture of the supraspinatus tendon Acromioclavicular joint osteoarthritis Calcific tendonitis Pregnancy and breastfeeding Presence of nerve damage or neurological disorders that cause upper limb dysfunction The existence of psychological problems History of shoulder surgery Patient's lack of cooperation in assessing range of motion History of corticosteroid injection into the shoulder within the past 6 months Concomitant radiculopathy Coincidence with frozen shoulder Systemic inflammatory diseases History of sensitivity to botulonium toxin History of sensitivity to corticosteroid

Design outcomes

Primary

MeasureTime frame
Shoulder range of motion. Timepoint: Before injection,1and 3 months later. Method of measurement: Physical exam and questioner.;Shoulder pain. Timepoint: Before injection,1and 3 months later. Method of measurement: Questioner.

Secondary

MeasureTime frame
Quality of life. Timepoint: Before injection,1and 3months later. Method of measurement: Questioner.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mansoor raygani

Shahid Beheshti University of Medical Sciences

mahboobeghanbarian313@gmail.com+98 21 2352 3710

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026