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Completed

NCT Number: NCT03447158

Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

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

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Key information

Conditions

Subacromial Bursitis

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MacKay Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

15% Dextrose

Procedure

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

Normal saline

Procedure

inject normal saline and xylocaine into subacrominal bursa under sonographically guidance

Primary outcomes

  1. Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy

    Time frame: before therapy sections, 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 outcomes

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

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

    abduction and flexion

  2. Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy

    Time frame: before therapy sections, 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.

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

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

    Thickness of bursa and elastogram

  4. Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy

    Time frame: before therapy sections, 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.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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