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

July 18, 2024 updated by: Ru-Lan Hsieh, Taipei Medical University

Comparing the Efficacy of Cross-Linked and Non-Cross-Linked Hyaluronic Acid in Treating Subdeltoid Bursitis: A Double-Blind, Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cross-linked hyaluronic acid group
cross-linked hyaluronic acid injection, one-time, plus physical therapy
Drug: cross-linked hyaluronic acid
cross-linked hyaluronic acid injection with physical therapy
Other Names:
  • physical therapy
Active Comparator: non-cross-linked hyaluronic acid group
non-cross-linked hyaluronic acid injection, one-time, plus physical therapy
Drug: non-cross-linked hyaluronic acid
non-cross-linked hyaluronic acid injection with physical therapy
Other Names:
  • physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain and disability index
Time Frame: 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
score change from baseline to 1 week, 1 month and 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the arm, shoulder, and hand
Time Frame: 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
score change from baseline to 1 week, 1 month and 3 months after treatment
Visual analog scale
Time Frame: 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
score change from baseline to 1 week, 1 month and 3 months after treatment
range of motion
Time Frame: 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
score change from baseline to 1 week, 1 month and 3 months after treatment
Brief version of the World Health Organization Quality of Life Scale
Time Frame: 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
score change from baseline to 1 week, 1 month and 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Investigators

  • Study Chair: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024SKHADR036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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