Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Subacromial Bursitis
• Intervention / Treatment: Procedure: 15% Dextrose; Procedure: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15% Dextrose group; 4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance	Procedure: 15% Dextrose; inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
Placebo Comparator: control group; 4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance	Procedure: Normal saline; inject normal saline and xylocaine into subacrominal bursa under sonographically guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 18MMHIS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No