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Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Primary Purpose

Subacromial Bursitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
15% Dextrose
Normal saline
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Bursitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 20-65 years-old
  2. pain lasting >3 months
  3. Painful arc between 40° to 120° in abduction
  4. positive Neer and Hawkins-Kennedy tests
  5. positive Empty can test
  6. pain in daily living activities
  7. Bursa thickness more than 2mm in ultrasound
  8. Rotator cuff tendinopathy

Exclusion Criteria:

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

Sites / Locations

  • MacKay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

15% Dextrose group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy
Thickness of bursa and elastogram
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.

Full Information

First Posted
February 14, 2018
Last Updated
January 23, 2020
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03447158
Brief Title
Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis
Official Title
Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Bursitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15% Dextrose group
Arm Type
Experimental
Arm Description
4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance
Intervention Type
Procedure
Intervention Name(s)
15% Dextrose
Intervention Description
inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
Intervention Type
Procedure
Intervention Name(s)
Normal saline
Intervention Description
inject normal saline and xylocaine into subacrominal bursa under sonographically guidance
Primary Outcome Measure Information:
Title
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy
Description
abduction and flexion
Time Frame
before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Title
Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy
Description
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
Title
Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy
Description
Thickness of bursa and elastogram
Time Frame
before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Title
Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-65 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 Exclusion Criteria: 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
Facility Information:
Facility Name
MacKay Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32926850
Citation
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.
Results Reference
derived

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Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

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