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Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05918146
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
12.4
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
Anticipated Study Start Date :
Jun 20, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Dextrose injection, one time

Drug: Dextrose
Dextrose injection plus physical therapy
Other Names:
  • physical therapy

    		•
    Placebo Comparator: Control group

    Normal saline injection, one time

    Drug: Normal saline
    Normal saline injection plus physical therapy
    Other Names:
  • physical therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Shoulder pain and disability index [score change from baseline to 1 week, 1 month and 3 months after treatment]

      measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability

    Secondary Outcome Measures

    1. Disabilities of the arm, shoulder, and hand [score change from baseline to 1 week, 1 month and 3 months after treatment]

      measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability

    2. Visual analog scale [score change from baseline to 1 week, 1 month and 3 months after treatment]

      measure shoulder pain, ranges from 0-10, higher score indicate more pain

    3. range of motion [score change from baseline to 1 week, 1 month and 3 months after treatment]

      measure shoulder range of motion, higher score indicate higher range of motion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up
    Exclusion Criteria:
    • history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan 111-01

    Sponsors and Collaborators

    • Taipei Medical University

    Investigators

    • Study Chair: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ru-Lan Hsieh, MD, Professor, Taipei Medical University
    ClinicalTrials.gov Identifier:
    NCT05918146
    Other Study ID Numbers:
    • 2023SKHADR033
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 27, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ru-Lan Hsieh, MD, Professor, Taipei Medical University
    subdeltoid bursitis
    dextrose
    physical therapy
    Additional relevant MeSH terms:
    Bursitis

    Study Results

    No Results Posted as of Jun 27, 2023