An interventional study of hypertonic dextrose water and Triamcinolone Acetonide. in Chronic Shoulder Pain, sponsored by Taipei Medical University Shuang Ho Hospital. Status unknown at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Treatment
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.
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Taipei Medical University Shuang Ho Hospital is the lead sponsor of 100 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
echo guide 20% dextrose water 3ml was injection in lesion site
Drug: hypertonic dextrose water
Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group
Drug: Triamcinolone Acetonide.
20% hypertonic dextrose water injection for chronic shoulder pain
Also known as: Prolotherapy group
Triamcinolone Acetonide 40mg/1ml injection
Also known as: comparatice group
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.
Time frame: Week0 Week2 Week6 Week12
Ultrasound
The ultrasound evaluated the thickness of subarcomial bursa
Time frame: Week0 Week2 Week6 Week12
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.
Time frame: 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.
Time frame: Week0 Week2 Week6 Week12
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taipei Medical University Shuang Ho Hospital