Comparison of ultrasound guided injection of hyaluronic acid, hyaluronidase enzyme and triamcinolone in the treatment of frozen shoulder

Phase 3

Recruiting

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

Registration Number: IRCT20130523013442N32

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

People aged 25 to 70 years have been diagnosed with adhesive capsulitis based on history and physical examination and did not respond to conservative treatments including non-steroidal pain relievers, exercise therapy and physical modalities.
According to VAS criteria, they have scored 5 or higher.
More than 30 degrees restriction of shoulder active range of motion in at least 2 of 4 directions of motion (abduction, flexion, external rotation and internal rotation) compared to the range of motion of the healthy shoulder (opposite side).
Less than 6 months have passed since the onset of symptoms.

Exclusion Criteria

History of shoulder trauma in the last 6 months
History of humerus bone fracture, supraspinatus tear, subacromial bursitis, calcific tendonitis and acromioclavicular joint osteoarthritis
Pregnancy and breastfeeding.
The presence of nerve injury or the presence of neurological disorders that cause dysfunction of the upper limbs, including brachial plexus plexopathy, hemiplegia and peripheral nerve injury
Known allergy or sensitivity to hyalase, hyaluronic acid, or corticosteroids
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 shoulder intra-articular injection of corticosteroids and hyaluronic acid in the last 6 months
Inflammatory systemic diseases, hypothyroidism, hyperthyroidism and diabetes
Use of anticoagulants

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 8 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 8 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 8 weeks and 24 weeks after the intervention. Method of measurement: Oxford Shoulder Score (OSS).

Secondary Outcome Measures

Name	Time	Method
The degree of patient's satisfaction with the treatment. Timepoint: At the beginning of the study (before intervention) and 8 weeks and 24 weeks after the intervention. Method of measurement: 5-items questionnaire.