NCT03447158

Brief Summary

The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

February 14, 2018

Last Update Submit

January 23, 2020

Conditions

Subacromial Bursitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy

Secondary Outcomes (4)

  • Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy

    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

    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

    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

    before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy

Study Arms (2)

15% Dextrose group

EXPERIMENTAL

4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance

Procedure: 15% Dextrose

control group

PLACEBO COMPARATOR

4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance

Procedure: Normal saline

Interventions

15% DextrosePROCEDURE

inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance

15% Dextrose group
Normal salinePROCEDURE

inject normal saline and xylocaine into subacrominal bursa under sonographically guidance

control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years-old
  • pain lasting \>3 months
  • Painful arc between 40° to 120° in abduction
  • positive Neer and Hawkins-Kennedy tests
  • positive Empty can test
  • pain in daily living activities
  • Bursa thickness more than 2mm in ultrasound
  • Rotator cuff tendinopathy

You may not qualify if:

  • history of significant shoulder trauma
  • history of surgery, fracture, or dislocation
  • adhesive capsulitis
  • full thickness rotator cuff tear
  • a long head of bicep tendon tear
  • Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose)
  • previous shoulder steroid injection in one month
  • had any rheumatologic, systemic, or neurologic disorders
  • patients taking regular systemic NSAIDs or steroids
  • pregnant or breastfeeding mothers
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacKay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Chang YJ, Chang FH, Hou PH, Tseng KH, Lin YN. Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):245-250. doi: 10.1016/j.apmr.2020.08.010. Epub 2020 Sep 11.

    PMID: 32926850DERIVED

MeSH Terms

Interventions

GlucoseSaline Solution

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 27, 2018

Study Start

July 18, 2018

Primary Completion

September 25, 2019

Study Completion

January 23, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

TW(1)