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NCT Number: NCT06508125

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

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.

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Key information

Conditions

Subdeltoid Bursitis Hyaluronic Acid

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cross-linked hyaluronic acid

Drug

cross-linked hyaluronic acid injection with physical therapy

Other names: physical therapy

non-cross-linked hyaluronic acid

Drug

non-cross-linked hyaluronic acid injection with physical therapy

Other names: physical therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

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

Ru-Lan Hsieh, MD

CONTACT

[email protected]

882-2-28332211 ext. 2538

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Jul 19, 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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