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

NCT06508125 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024SKHADR036
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Subdeltoid Bursitis; Hyaluronic Acid

Keywords

Subdeltoid Bursitis; Hyaluronic acid; cross linked

Outcome Measures

Primary Outcomes (1)

• Shoulder pain and disability index

  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 Outcomes (4)

• Disabilities of the arm, shoulder, and hand

  score change from baseline to 1 week, 1 month and 3 months after treatment

• Visual analog scale

  score change from baseline to 1 week, 1 month and 3 months after treatment

• 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

  score change from baseline to 1 week, 1 month and 3 months after treatment

Study Arms (2)

cross-linked hyaluronic acid group

EXPERIMENTAL

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

Drug: cross-linked hyaluronic acid

non-cross-linked hyaluronic acid group

ACTIVE COMPARATOR

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

Drug: non-cross-linked hyaluronic acid

Interventions

cross-linked hyaluronic acid DRUG

cross-linked hyaluronic acid injection with physical therapy

Also known as: physical therapy

cross-linked hyaluronic acid group

non-cross-linked hyaluronic acid DRUG

non-cross-linked hyaluronic acid injection with physical therapy

Also known as: physical therapy

non-cross-linked hyaluronic acid group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Ru-Lan Hsieh, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

882-2-28332211; M001052@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 25, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)