Clinical trial NCT04931511: Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder
Official title: Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Frozen Shoulder
Shoulder Pain
Bursitis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.

Detailed description: In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.

Eligibility criteria: Inclusion Criteria:

* 1. Primary frozen shoulder
* 2. Older than 18 years of age and less than 75 years of age
* 3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
* 4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
* 5. corticosteroid injections were not given within 3 months of visit

Exclusion Criteria:

* 1. A history of trauma, osteoarthritis, tumors, etc.
* 2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
* 3. There is a history of corticosteroid injections within 3 months of visit
* 4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
* 5. Both side shoulder joints become ill at the same time
* 6. The patient has not signed an informed consent form

Primary outcomes:
measure: The Change of Shoulder Pain and Disability Index (SPADI)
timeFrame: 0,1,2,4,8,12 weeks
Secondary outcomes:
measure: The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)
timeFrame: 0,1,2,4,8,12 weeks
measure: Anterior flexion of shoulder joint (0-180°)
timeFrame: 0,1,2,4,8,12 weeks
measure: shoulder joint abduction (0-180°)
timeFrame: 0,1,2,4,8,12 weeks
measure: shoulder internal rotator (1-18 score)
timeFrame: 0,1,2,4,8,12 weeks
measure: shoulder external rotator (0-180°)
timeFrame: 0,1,2,4,8,12 weeks
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University
name: Pintong Huang
role: PRINCIPAL_INVESTIGATOR
References: