Hydrodilatation With Hypertonic Dextrose Solution Injection After Intra-articular Steroid Injection for Frozen Shoulder

NCT06165939 | Unknown

• 1 other identifier: B202305141
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder.

Conditions

Frozen Shoulder

Keywords

Frozen Shoulder; hypertonic dextrose injection; Steroid Injection; Hydrodilatation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.

  the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months

Secondary Outcomes (2)

• Range of Motion (ROM)

  the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months

• Shoulder Pain and Disability Index (SPADI)

  the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months

Study Arms (2)

Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose

EXPERIMENTAL

The patient receives ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection with 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml Normal saline, totaling 20 ml). The entire treatment comprises two sessions.

Drug: Intra-articular corticosteroid injection; Drug: hydrodilation with 15% hypertonic dextrose

Intra-articular corticosteroid injection and hydrodilation with Normal saline

PLACEBO COMPARATOR

The patient receives ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection with 15% hypertonic dextrose ( 2 ml 2% Xylocaine + 18 ml Normal saline, totaling 20 ml). The entire treatment comprises two sessions.

Drug: Intra-articular corticosteroid injection; Drug: hydrodilation with Normal saline

Interventions

Intra-articular corticosteroid injection DRUG

Ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine) is performed once for the patient at the first week.

Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose; Intra-articular corticosteroid injection and hydrodilation with Normal saline

hydrodilation with 15% hypertonic dextrose DRUG

The second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml normal saline, totaling 20 ml).

Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose

hydrodilation with Normal saline DRUG

The second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is Normal saline (2 ml 2% Xylocaine + 18 ml normal saline, totaling 20 ml).

Intra-articular corticosteroid injection and hydrodilation with Normal saline

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of frozen shoulder is determined by physicians through an evaluation of the patient's medical history, physical examination, and assessment of X-ray and ultrasound reports.
• The duration of symptoms should be more than 3 months.
• There should be a decrease of at least 30 degrees in a minimum of two shoulder joint angles (shoulder flexion, abduction, and external rotation) compared to the corresponding angles on the healthy side.

You may not qualify if:

• Ultrasound examination of the shoulder muscles must not reveal a complete tear or massive tear of the rotator cuff tendon or evidence of calcific tendinitis.
• Presence of systemic rheumatic disease.
• History of previous shoulder fracture or undergoing surgical intervention.
• Receipt of shoulder joint injections within the last 3 months.
• Acute cervical nerve root compression.
• Current status of pregnancy or breastfeeding.
• Poorly controlled diabetes (since intravenous glucose injection may cause temporary blood sugar elevation).
• Patients with a history of cancer.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Conditions

Bursitis

Interventions

Adrenal Cortex Hormones; Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Chih-Ya Chang, MD

CONTACT

886-2-87923311; gradesboy@gmail.com

Chia-Ying Lai, MD

CONTACT

886-2-87923311; pokerface165@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12