Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis

The aim of this study is to investigate the echoguide hypertonic injection and compared steroid injection in subacromial bursitis patients about clinical and ultrasound image presentation.

Study Overview

• Status: Recruiting
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Drug: hypertonic dextrose water; Drug: Triamcinolone Acetonide.

Detailed Description

Subacromial bursitis is one of the major causes of chronic refractory shoulder pain. It can cause patients with shoulder pain when shoulder exercise and heavy lifting and limiting the range of motion. It can also influence the sleep quality due to pain symptoms of the shoulder. Usually, these patients had limited response to medication and physical modality. Steroid injection was often adopted for intervention, but the adverse effects should be considered. Therefore, prolotherapy was taken as an alternative treatment for chronic subacromial bursitis. It involves the injection of small volumes of an irritant agent, most commonly a hyperosmolar dextrose solution, at the lesion site. Hyperosmolar dextrose appears to be the most commonly used agent today. The aim of this study is to investigate hypertonic injections in subacromial bursitis patients about clinical and ultrasound image presentation. The investigators conducted a double-blinded randomized controlled trial for 60 participants with chronic shoulder pain for 3 months with subacromial bursitis. In the study group, the echo guide 20% dextrose water was injected into the lesion site, and the control group received the echo guide steroid injection. ROM, SPADI, VAS, x-ray, and ultrasound data were obtained at baseline. At weeks 2, 6, 12, ROM, SPADI, VAS, and ultrasound data were evaluated. The ANOVA and independent t-test are applied for analysis by SPSS 20.0 with a P value less than 0.05 as statistical significance.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ShihWei Huang; Phone Number: 1601 +88622490088; Email: 13001@s.tmu.edu.tw

Study Locations

• Taiwan
  • Zhonghe Dist
    • New taipei city, Zhonghe Dist, Taiwan, 235
      • Not yet recruiting
      • Shuang Ho Hospital
    • New taipei city, Zhonghe Dist, Taiwan, 235
      • Recruiting
      • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
      • Contact: ShihWei Huang; Phone Number: 1601 +88622490088; Email: 13001@s.tmu.edu.tw

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: 20% hypertonic dextrose water injection group; echo guide 20% dextrose water 3ml was injection in lesion site	Drug: hypertonic dextrose water; 20% hypertonic dextrose water injection for chronic shoulder pain; Other Names: Prolotherapy group
Active Comparator: Steroid injection group; Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group	Drug: Triamcinolone Acetonide.; Triamcinolone Acetonide 40mg/1ml injection; Other Names: comparatice group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder ROM (Range of Motion)	Pain-free passive range of motion (PROM) of the shoulder was designated as the range of motion attained at the most painful position and was measured using a digital goniometer in 6 directions flexion, extension, abduction, adduction, external rotation and internal rotation. Five directions of the shoulder joint were measured (flexion, abduction, adduction, internal rotation, and external rotation) while participants were lying in a supine position. Additionally, shoulder extension was measured in the side-lying position.	Week0 Week2 Week6 Week12
Pain (VAS, Visual Analogue Scale)	Shoulder pain was assessed according to an 11-point numerical rating scale (NRS). This tool was simple to use and was highly correlated with the visual analog scale, verbal rating scale, and Faces Pain Scale-Revised. The NRS is considered a valid and reliable pain assessment tool. The pain intensity was graded from 0 (no pain) to 10 (the most intense level of pain). The participants reported their pain level at rest and during the movement of shoulder joint in all direction. The most painful movement score was used for further data analysis.	Week0 Week2 Week6 Week12
Ultrasound	The ultrasound evaluated the thickness of subarcomial bursa	Week0 Week2 Week6 Week12

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Study Chair: Lien-Chieh Lin, Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; subacromial bursitis; Prolotherapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Bursitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: N201812061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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