Cross-linked and Non-cross-linked Hyaluronic Acid in Subdeltoid Bursitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-80
SponsorTaipei Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
history of malignancy
previous shoulder operation or injury
previous shoulder injections in the past three months
Trial design
Design model
Parallel
Treatments tested in this trial
cross-linked hyaluronic acid
Drugcross-linked hyaluronic acid injection with physical therapy
non-cross-linked hyaluronic acid
Drugnon-cross-linked hyaluronic acid injection with physical therapy
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: cross-linked hyaluronic acid groupExperimental treatment 1 intervention
Group B: non-cross-linked hyaluronic acid groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Shoulder pain and disability index
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
Time frame
score change from baseline to 1 week, 1 month and 3 months after treatmentSecondary outcomes
1
Disabilities of the arm, shoulder, and hand
measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability
Time frame
score change from baseline to 1 week, 1 month and 3 months after treatment2
Visual analog scale
measure shoulder pain, ranges from 0-10, higher score indicate more pain
Time frame
score change from baseline to 1 week, 1 month and 3 months after treatment3
range of motion
measure shoulder range of motion, higher score indicate higher range of motion
Time frame
score change from baseline to 1 week, 1 month and 3 months after treatment4
Brief version of the World Health Organization Quality of Life Scale
measure quality of life, ranges from 0-100, higher scores indicate better quality of life
Time frame
score change from baseline to 1 week, 1 month and 3 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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