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Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis:The Effect of the Rotator Cuff Interval With Posterior Glenohumeral Recess Approaches on the Improvement of Joint Motion and Pain

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06553716
Enrollment
70
Registered
2024-08-14
Start date
2024-02-05
Completion date
2024-11-30
Last updated
2024-09-20

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

Conditions

Postoperation Pain

Keywords

Adhesive capsulitis, hydrodilatation, corticosteroid, rotator cuff interval, Posterior Glenohumeral Recess

Brief summary

The purpose of this study was to compare the efficacy of ultrasus-guided hydrodilation of Rotator Cuff Interval combined with Posterior Glenohumeral recess approach and hydrodilation of the Rotator cuff Interval alone in Adhesive Capsulitis.

Detailed description

For patients with perihumeral arthritis, shoulder capsule hydrodilation is usually performed using ultrasound-guided water dilation through the posterior glenohumeral recess. Recently, a new transrotator cuff space approach has been described, and this study was designed to compare the efficacy of triamcinolone olonide transrotator cuff space combined with posterior glenohumeral recess and rotator cuff space dilation in the treatment of adhesive joint capsitis.

Interventions

PROCEDUREUltrasound-Guided Hydrodilatation by the Rotator cuff interval recess

The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval recess group,we injected 20 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into into the Rotator cuff interval/anterior capsule.

PROCEDUREUltrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recess

The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval and posterior glenohumeral recess group,we injected 10 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the Rotator cuff interval/anterior capsule and 10 mL mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the posterior glenohumeral.

Sponsors

General Hospital of Ningxia Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age ≥18 years old, clinical diagnosis of periarthritis of shoulder; 2. symptom duration \> 1 month, shoulder ROM limitation in at least two directions, defined as abduction \< 80°, flexion \< 130°, and rotation \< 30°; 3. Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.

Exclusion criteria

1. Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome; 2. Previous history of shoulder joint surgery; 3. Involved cervical nervous system symptoms or abnormal nervous system; 4. corticosteroid injection in the affected shoulder within 3 months; 5. Mental illness; 6. Patients with contraindications to cortisol-hormone use.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain and Disability IndexAt baseline, one week, three weeks, six weeks, 12 weeks after treatment.The SPADI was used to assess the severity ofpain and disability. A previous study has shown that the Chinese version of the SPADI has high internal consistency and test-retest reliability (Yao et al., 2017). It consists of 13 items that are divided into 2 subscales: pain scale (5 items) and disability scale (8 items) (Roach et al., 1991). Each item is rated from 0 (no pain/no difficulty) to 10 (worst pain experienced/ very difficult). The score is then transformed to a 100-point scale, with the highest score indicating the most severe pain and disability. In the literature, the minimal and clinically relevant difference for SPADI has been reported to be 10 points

Secondary

MeasureTime frameDescription
visual analogue scaleAt baseline, one week, three weeks, six weeks, 12 weeks after treatment.Regarding VAS, patients were asked to indicate the intensity of their average level ofpain in the affected shoulder within the past 1 week using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).
Active shoulder range of motionBaseline data, six weeks,12 weeks after treatmentIn terms of ROM, the degrees of shoulder flexion, abduction, external and internal rotation were measured by a goniometer in the supine position in a random sequence
adverse reactionone week after treatmentPain after hydrodilation , reduced sensation and motor control of the affected arm, skin flushing, nausea, dizziness, and fainting

Countries

China

Contacts

Primary ContactXinli Ni, MD
xinlini6@nyfy.com.cn13909586966
Backup ContactPeng Ma
2234073178@qq.com18209631464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026