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Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder

Comparison of ultrasound-guided corticosteroid and botulinum toxin in frozen shoulder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130523013442N31
Enrollment
60
Registered
2022-12-20
Start date
2022-09-11
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Adhesive capsulitis or Frozen shoulder. Adhesive capsulitis of shoulder

Interventions

Intervention 1: Intervention group: Includes 30 patients who are treated with 200 units of botulinum toxin (Masport, Masson Darou) and 1 cc of lidocaine intra-articularly. Intervention 2: Control grou

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: People aged 30 to 60 years Diagnosed with adhesive capsulitis based on history and physical examination No response to conservative treatments, including non-steroidal anti-inflammatory drugs, opioids, exercise therapy, and physical therapy. A score of 5 or higher based on the intensity of the pain (according to the VAS criteria) Less than 6 months have passed since the onset of the symptoms Have more than 30 degree reduction in the range of motion in at least 2 of the 4 directions of motion (abduction, flexion, external rotation, and internal rotation) compared to the range of motion of the healthy shoulder (opposite side)

Exclusion criteria

Exclusion criteria: History of shoulder trauma in the last 6 months History of humerus fracture Pregnancy and breastfeeding The presence of nerve damage or neurological disorders that cause dysfunction of the upper limbs, including brachial plexopathy, hemiplegia, and peripheral nerve damage. Allergy or known sensitivity to botulinum toxin or corticosteroids Presence of psychological problems History of shoulder surgery A patient who is unable to cooperate to check the range of motion due to severe pain History of intra-articular injection in the last 6 months Inflammatory systemic diseases Use of anticoagulants The presence of diseases that involve the connection between nerve and muscle, such as myasthenia gravis and Eaton Lambert

Design outcomes

Primary

MeasureTime frame
Active range of motion of shoulder. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Digital goniometer.;Assessment of shoulder pain. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS).;Assessment of the patient's performance in daily tasks. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Oxford Shoulder Score (OSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Nazari Nodoushan

Shahid Beheshti University of Medical Sciences

ali.nazari32@yahoo.com+98 21 2207 4087

Outcome results

None listed

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