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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130523013442N32
Enrollment
90
Registered
2023-09-13
Start date
2023-09-23
Completion date
Unknown
Last updated
2023-10-16

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 hyalase injection at the rate of 1500 units in 5 cc of normal saline along with 2 cc of 2% lidocaine. Intervention 2: Inte

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Nazari Nodoushan

Shahid Beheshti University of Medical Sciences

alin7093@gmail.com+98 21 2207 4087

Outcome results

None listed

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