Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients

NCT03000205 | Completed

• 1 other identifier: N201605022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Using hypertonic dextrose water for chronic supraspinatus tendinosis and using ultrasound as assessment tool to evaluate the effect of intervention.

Conditions

Chronic Shoulder Pain

Keywords

Dextrose prolotherapy; patients

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)

  Shoulder Pain and Disability Index (SPADI), a self-administered assessment tool that was used to measure pain and disability related to shoulder disease. The SPADI consists of 5 pain and 8 disability items that are measured on a visual analog scale. Pain and disability subscales were calculated as the mean of the corresponding items on a 0-100 scale; the highest score indicated the most severe pain and disability. The total outcome score used for statistical analysis was calculated as the sum of the pain and disability subscales.

  Week0 Week2 Week6 Week12

Secondary Outcomes (3)

• Ultrasound

  Week0 Week2 Week6 Week12

• Shoulder ROM (Range of Motion)

  Week0 Week2 Week6 Week12

• Pain (VAS, Visual Analogue Scale)

  Week0 Week2 Week6 Week12

Study Arms (2)

hypertonic dextrose water

EXPERIMENTAL

20% hypertonic dextrose water injection for chronic shoulder spin

Device: hypertonic dextrose water

Normal Saline

PLACEBO COMPARATOR

normal saline and Lidocaine as placebo for sham group

Device: Normal saline and Lidocaine.

Interventions

hypertonic dextrose water DEVICE

20% hypertonic dextrose water injection for chronic shoulder pain at Week0

Also known as: Prolotherapy group

hypertonic dextrose water

Normal saline and Lidocaine. DEVICE

Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)

Also known as: Control group

Normal Saline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months

You may not qualify if:

• History of shoulder fracture and operation, with frozen shoulder or full thickness rupture of rotator cuff, steroid, or hyaluronic acid, or platelet rich plasma (PRP) injection during the period of intervention and following up

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital

New Taipei City, Zhonghe Dist, 235, Taiwan

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: December 21, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: October 31, 2021
• Last Updated: April 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)