Chronic Shoulder PainNCT04916353
Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
A study testing hypertonic dextrose water and Triamcinolone Acetonide. in people with Chronic Shoulder Pain, run by Taipei Medical University Shuang Ho Hospital at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- hypertonic dextrose water and Triamcinolone Acetonide.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 10 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Shuang Ho Hospital
New Taipei City, Zhonghe Dist, 235
- Recruiting
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Zhonghe Dist, 235
ShihWei Huang, +88622490088 ext. 1601, 13001@s.tmu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Chronic Shoulder Pain
- Being tested
- hypertonic dextrose water, Triamcinolone Acetonide.
- Keywords
- Prolotherapy, subacromial bursitis, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic dextrose waterDrug
Also called Prolotherapy group
20% hypertonic dextrose water injection for chronic shoulder pain
Triamcinolone Acetonide.Drug
Also called comparatice group
Triamcinolone Acetonide 40mg/1ml injection
| Study group | Role | What they receive |
|---|---|---|
| 20% hypertonic dextrose water injection group | Experimental | echo guide 20% dextrose water 3ml was injection in lesion site Receives: Drug: hypertonic dextrose water |
| Steroid injection group | Active comparator | Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group Receives: Drug: Triamcinolone Acetonide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week0 Week2 Week6 Week12
Secondary outcomes (3)
Ultrasound
The ultrasound evaluated the thickness of subarcomial bursa
Measured: 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.
Measured: 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.
Measured: Week0 Week2 Week6 Week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Jun 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShihWei Huang, Taipei Medical University Shuang Ho Hospital
- Investigators
- Lien-Chieh Lin, Study chair, Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916353
- Sponsor's protocol ID
- N201812061
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
- ClinicalTrials.gov ID
- NCT04916353
- Acronym / sponsor ID
- N201812061
- Conditions
- Chronic Shoulder Pain
- Keywords
- Prolotherapy, subacromial bursitis, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% hypertonic dextrose water injection group | Experimental | Drug: hypertonic dextrose waterecho guide 20% dextrose water 3ml was injection in lesion site |
| Steroid injection group | Active comparator | Drug: Triamcinolone Acetonide.Triamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypertonic dextrose waterAlso: Prolotherapy group20% hypertonic dextrose water injection for chronic shoulder pain | Drug | 20% hypertonic dextrose water injection group |
| Triamcinolone Acetonide.Also: comparatice groupTriamcinolone Acetonide 40mg/1ml injection | Drug | Steroid injection group |
Primary outcome
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
Time frame: Week0 Week2 Week6 Week12
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.
3 secondary outcomes
Ultrasound
Time frame: Week0 Week2 Week6 Week12
Shoulder ROM (Range of Motion)
Time frame: Week0 Week2 Week6 Week12
Pain (VAS, Visual Analogue Scale)
Time frame: Week0 Week2 Week6 Week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Shoulder Pain
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Recruiting
Effects of Rotator Cuff Drills Versus Progressive Resistance Exercises on Chronic Rotator Cuff Tendinopathy
Rotator Cuff Tendinosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Active, not recruiting
Precision Medicine for Nociception, Sngception and Proprioception.
Rehabilitation, Pain, Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lien-Chieh Lin study chair
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic dextrose water and Triamcinolone Acetonide. in people with Chronic Shoulder Pain, run by Taipei Medical University Shuang Ho Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ShihWei Huang (+88622490088 ext. 1601, 13001@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI) (time frame: Week0 Week2 Week6 Week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.