Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeneral Hospital of Ningxia Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years old, clinical diagnosis of periarthritis of shoulder;

symptom duration > 1 month, shoulder ROM limitation in at least two directions, defined as abduction < 80°, flexion < 130°, and rotation < 30°;

Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.

Disqualifiers

Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome;

Previous history of shoulder joint surgery;

Involved cervical nervous system symptoms or abnormal nervous system;

corticosteroid injection in the affected shoulder within 3 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess

    Procedure/Surgery

    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.

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

    Procedure/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Rotator cuff space approach (GroupA)Active comparator 1 intervention
Group B: Rotator cuff space approach combined with posterior glenohumeral recess approach (GroupB)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Shoulder Pain and Disability Index

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

Time frame
At baseline, one week, three weeks, six weeks, 12 weeks after treatment.

Secondary outcomes

1

visual analogue scale

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).

Time frame
At baseline, one week, three weeks, six weeks, 12 weeks after treatment.
2

Active shoulder range of motion

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

Time frame
Baseline data, six weeks,12 weeks after treatment
3

adverse reaction

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

Time frame
one week after treatment

Other outcomes

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