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NCT Number: NCT06553716

Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Mental illness;
  • Patients with contraindications to cortisol-hormone use.

Treatment and study plan

Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess

Procedure

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

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.

Primary outcomes

  1. Shoulder Pain and Disability Index

    Time frame: At 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 outcomes

  1. visual analogue scale

    Time frame: At 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).

  2. Active shoulder range of motion

    Time frame: Baseline 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

  3. adverse reaction

    Time frame: one week after treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Ma

CONTACT

[email protected]

18209631464

Xinli Ni, MD

CONTACT

[email protected]

13909586966

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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