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

NCT ID: NCT06508125

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2024-12-31

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.

Conditions

Subdeltoid Bursitis; Hyaluronic Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

cross-linked hyaluronic acid group

cross-linked hyaluronic acid injection, one-time, plus physical therapy

Group Type: EXPERIMENTAL

cross-linked hyaluronic acid

Intervention Type: DRUG

cross-linked hyaluronic acid injection with physical therapy

non-cross-linked hyaluronic acid group

non-cross-linked hyaluronic acid injection, one-time, plus physical therapy

Group Type: ACTIVE_COMPARATOR

non-cross-linked hyaluronic acid

Intervention Type: DRUG

non-cross-linked hyaluronic acid injection with physical therapy

Interventions

cross-linked hyaluronic acid

cross-linked hyaluronic acid injection with physical therapy

Intervention Type: DRUG

non-cross-linked hyaluronic acid

non-cross-linked hyaluronic acid injection with physical therapy

Intervention Type: DRUG

Other Intervention Names

physical therapy; physical therapy

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ru-Lan Hsieh

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ru-Lan Hsieh, MD

Role: STUDY_CHAIR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Ru-Lan Hsieh, MD

Role: CONTACT

M001052@ms.skh.org.tw

882-2-28332211 ext. 2538

Other Identifiers

2024SKHADR036

Identifier Type: -

Identifier Source: org_study_id