Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2020-01-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Subacromial Bursitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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15% Dextrose group

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

Group Type EXPERIMENTAL

15% Dextrose

Intervention Type PROCEDURE

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

control group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type PROCEDURE

inject normal saline and xylocaine into subacrominal bursa under sonographically guidance

Interventions

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15% Dextrose

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

Intervention Type PROCEDURE

Normal saline

inject normal saline and xylocaine into subacrominal bursa under sonographically guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes