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

Phase 3

Recruiting

Conditions: Adhesive capsulitis or Frozen shoulder.
Adhesive capsulitis of shoulder
M75.0

Registration Number: IRCT20130523013442N31

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures