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Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

Not Applicable
Recruiting
Conditions
Postoperation Pain
Interventions
Procedure: Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess
Procedure: Ultrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recess
Registration Number
NCT06553716
Lead Sponsor
General Hospital of Ningxia Medical University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria
    1. Age ≥18 years old, clinical diagnosis of periarthritis of shoulder; 2) (i) symptom duration > 1 month, (ii) 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Rotator cuff space approach (GroupA)Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recessIn 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.
Rotator cuff space approach combined with posterior glenohumeral recess approach (GroupB)Ultrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recessIn 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.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Active shoulder range of motionBaseline data, six weeks,12 weeks after treatment

In 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 treatment

Pain after hydrodilation , reduced sensation and motor control of the affected arm, skin flushing, nausea, dizziness, and fainting

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).

Trial Locations

Locations (1)

General hospital of Ningxia medical university

🇨🇳

Yinchuan, Ningxia, China

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