An interventional study of 15% Dextrose and Normal saline in Subacromial Bursitis, sponsored by Mackay Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Treatment
The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .
Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.
Exclusion Criteria:
4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance
Procedure: 15% Dextrose
4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance
Procedure: Normal saline
inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
inject normal saline and xylocaine into subacrominal bursa under sonographically guidance
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
maximal visual analog scale (VAS) in the past week during shoulder activity. Visual analog scale is range from 0-10. The higher score indicated more severe pain.
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy
abduction and flexion
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy
Shoulder pain and disability questionnaire with two subscales, pain scale and function scale. Pain scale is range from 0-50. The higher scale indicates worse pain outcome. Function scale is range from 0-80. The higher scale indicates poor shoulder function. The total scale is summation of pain scale and function scale.
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy
Thickness of bursa and elastogram
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy
maximal visual analog scale (VAS) in the past week during resting. Visual analog scale is range from 0-10. The higher score indicated more severe pain.
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mackay Memorial Hospital