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

Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916353
• Other study ID #: N201812061
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: ShihWei Huang
• Phone: +88622490088
• Email: 13001[@]s.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Chronic Shoulder Pain
• Shoulder Pain

Intervention

Drug:
• hypertonic dextrose water
20% hypertonic dextrose water injection for chronic shoulder pain
• Triamcinolone Acetonide.
Triamcinolone Acetonide 40mg/1ml injection

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital	New taipei city	Zhonghe Dist
Taiwan	Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare	New taipei city	Zhonghe Dist

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ultrasound	The ultrasound evaluated the thickness of subarcomial bursa	Week0 Week2 Week6 Week12
Secondary	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
Secondary	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