Cross-linked and Non-cross-linked Hyaluronic Acid in Subdeltoid Bursitis

Phase 4

Not yet recruiting

• Conditions: Hyaluronic Acid; Subdeltoid Bursitis
• Interventions: Drug: cross-linked hyaluronic acid; Drug: non-cross-linked hyaluronic acid

• Registration Number: NCT06508125
• Lead Sponsor: Taipei Medical University

Brief Summary

This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

Detailed Description

A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) will be arranged.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-18
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Study Start: 2024-07-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• clinical diagnosis of subdeltoid bursitis
• age 20 or older 20
• at least one positive in the painful arc, neer test, or Hawkins test
• can attend three months of intervention and follow-up

Exclusion Criteria

• history of malignancy
• previous shoulder operation or injury
• previous shoulder injections in the past three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cross-linked hyaluronic acid group	cross-linked hyaluronic acid	cross-linked hyaluronic acid injection, one-time, plus physical therapy
non-cross-linked hyaluronic acid group	non-cross-linked hyaluronic acid	non-cross-linked hyaluronic acid injection, one-time, plus physical therapy

Primary Outcome Measures

Name	Time	Method
Shoulder pain and disability index	score change from baseline to 1 week, 1 month and 3 months after treatment	measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability

Secondary Outcome Measures

Name	Time	Method
range of motion	score change from baseline to 1 week, 1 month and 3 months after treatment	measure shoulder range of motion, higher score indicate higher range of motion
Visual analog scale	score change from baseline to 1 week, 1 month and 3 months after treatment	measure shoulder pain, ranges from 0-10, higher score indicate more pain
Disabilities of the arm, shoulder, and hand	score change from baseline to 1 week, 1 month and 3 months after treatment	measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability
Brief version of the World Health Organization Quality of Life Scale	score change from baseline to 1 week, 1 month and 3 months after treatment	measure quality of life, ranges from 0-100, higher scores indicate better quality of life

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan