Frozen ShoulderNCT06165939
Hydrodilatation With Hypertonic Dextrose Solution Injection After Intra-articular Steroid Injection for Frozen Shoulder
A study testing Intra-articular corticosteroid injection, hydrodilation with 15% hypertonic dextrose and hydrodilation with Normal saline in people with Frozen Shoulder, run by Tri-Service General Hospital (TSGH).
Trial summary
This study aims to investigate whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Intra-articular corticosteroid injection, hydrodilation with 15% hypertonic dextrose and hydrodilation with Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of frozen shoulder is determined by physicians through an evaluation of the patient's medical history, physical examination, and assessment of X-ray and ultrasound reports.
- The duration of symptoms should be more than 3 months.
- There should be a decrease of at least 30 degrees in a minimum of two shoulder joint angles (shoulder flexion, abduction, and external rotation) compared to the corresponding angles on the healthy side.
Who cannot join
- Ultrasound examination of the shoulder muscles must not reveal a complete tear or massive tear of the rotator cuff tendon or evidence of calcific tendinitis.
- Presence of systemic rheumatic disease.
- History of previous shoulder fracture or undergoing surgical intervention.
- Receipt of shoulder joint injections within the last 3 months.
- Acute cervical nerve root compression.
- Current status of pregnancy or breastfeeding.
- Poorly controlled diabetes (since intravenous glucose injection may cause temporary blood sugar elevation).
- Patients with a history of cancer.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Hydrodilatation With Hypertonic Dextrose Solution Injection After Intra-articular Steroid Injection for Frozen Shoulder Treatment: A Randomized Controlled Trial
This study aims to investigate whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder.
Read the detailed description
Frozen shoulder (FS), also known as adhesive capsulitis, is a prevalent shoulder condition, with an annual incidence of around 2.4 individuals per 100,000, representing approximately 2% of the total population. Symptoms typically manifest in individuals aged forty to sixty years, characterized by persistent limitations in shoulder joint mobility accompanied by pain.
While the specific mechanisms driving frozen shoulder remain unclear, arthroscopic examination of the shoulder joint reveals thickening and contraction of the shoulder joint capsule, adhesion with the humeral head, and a reduction in joint cavity volume, particularly in the folds of the axillary recess of the joint capsule and its surrounding areas. These changes contribute to restricted shoulder joint mobility. Additionally, research suggests that severe inflammation may lead certain cytokines and growth factors to drive fibroblasts to replace normal tissue through repair and remodeling responses. This excessive fibrosis, along with the loss of a normal collagen remodeling response, further contributes to the development of frozen shoulder.
The 2020 meta-analysis published in JAMA Network underscored the importance of medium to long-term physical therapy in enhancing subsequent improvements in range of motion and functionality for patients with adhesive capsulitis or frozen shoulder. Furthermore, numerous studies indicate that combining intra-articular injections with shoulder joint capsular distension procedures, such as hydrodilatation, can enhance shoulder joint function and mobility.
Prolotherapy, a non-surgical regenerative injection therapy, involves injecting a solution into painful or degenerated areas. The injected proliferants induce a local inflammatory response, triggering the release of growth factors and stimulating fibroblasts and collagen-producing cells. This process mimics the natural healing mechanisms of the body, promoting cellular tissue growth through a beneficial inflammatory response. In clinical practice, the most commonly utilized solution for prolotherapy is hypertonic dextrose, with concentrations ranging from 15% to 25%. Concentrations exceeding 10% are generally considered to induce local inflammation, thereby initiating a cascade of reparative effects.
Although numerous studies have investigated shoulder joint capsular distension procedures in the past, the injected solutions often comprised corticosteroids and saline. In clinical observations, the use of hypertonic dextrose injection combined with shoulder joint capsular distension appears to yield improved outcomes in terms of pain relief and joint angle progression in patients with adhesive capsulitis. However, there is currently no research investigating the effectiveness of hypertonic dextrose injection combined with shoulder joint capsular distension for treating frozen shoulder. This study aims to explore whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder.
- Conditions
- Frozen Shoulder
- Being tested
- Intra-articular corticosteroid injection, hydrodilation with 15% hypertonic dextrose, hydrodilation with Normal saline
- Keywords
- Frozen Shoulder, hypertonic dextrose injection, Steroid Injection, Hydrodilatation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular corticosteroid injectionDrug
Ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine) is performed once for the patient at the first week.
hydrodilation with 15% hypertonic dextroseDrug
The second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml normal saline, totaling 20 ml).
hydrodilation with Normal salineDrug
The second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is Normal saline (2 ml 2% Xylocaine + 18 ml normal saline, totaling 20 ml).
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose | Experimental | The patient receives ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection with 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml Normal saline, totaling 20 ml). The entire treatment comprises two sessions. Receives: Drug: Intra-articular corticosteroid injection; Drug: hydrodilation with 15% hypertonic dextrose |
| Intra-articular corticosteroid injection and hydrodilation with Normal saline | Placebo comparator | The patient receives ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection with 15% hypertonic dextrose ( 2 ml 2% Xylocaine + 18 ml Normal saline, totaling 20 ml). The entire treatment comprises two sessions. Receives: Drug: Intra-articular corticosteroid injection; Drug: hydrodilation with Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
Measured: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
Secondary outcomes (2)
Range of Motion (ROM)
Using a standardized goniometer, passive shoulder joint range of motion angles on the affected side are measured in standard positions, including flexion, extension, abduction, external rotation, and internal rotation.
Measured: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
Shoulder Pain and Disability Index (SPADI)
Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.
Measured: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Ya Chang, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165939
- Sponsor's protocol ID
- B202305141
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hydrodilatation With Hypertonic Dextrose Solution Injection After Intra-articular Steroid Injection for Frozen Shoulder Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06165939
- Acronym / sponsor ID
- B202305141
- Conditions
- Frozen Shoulder
- Keywords
- Frozen Shoulder, hypertonic dextrose injection, Steroid Injection, Hydrodilatation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 2023 (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.
This study aims to investigate whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder.
Detailed description
Frozen shoulder (FS), also known as adhesive capsulitis, is a prevalent shoulder condition, with an annual incidence of around 2.4 individuals per 100,000, representing approximately 2% of the total population. Symptoms typically manifest in individuals aged forty to sixty years, characterized by persistent limitations in shoulder joint mobility accompanied by pain.
While the specific mechanisms driving frozen shoulder remain unclear, arthroscopic examination of the shoulder joint reveals thickening and contraction of the shoulder joint capsule, adhesion with the humeral head, and a reduction in joint cavity volume, particularly in the folds of the axillary recess of the joint capsule and its surrounding areas. These changes contribute to restricted shoulder joint mobility. Additionally, research suggests that severe inflammation may lead certain cytokines and growth factors to drive fibroblasts to replace normal tissue through repair and remodeling responses. This excessive fibrosis, along with the loss of a normal collagen remodeling response, further contributes to the development of frozen shoulder.
The 2020 meta-analysis published in JAMA Network underscored the importance of medium to long-term physical therapy in enhancing subsequent improvements in range of motion and functionality for patients with adhesive capsulitis or frozen shoulder. Furthermore, numerous studies indicate that combining intra-articular injections with shoulder joint capsular distension procedures, such as hydrodilatation, can enhance shoulder joint function and mobility.
Prolotherapy, a non-surgical regenerative injection therapy, involves injecting a solution into painful or degenerated areas. The injected proliferants induce a local inflammatory response, triggering the release of growth factors and stimulating fibroblasts and collagen-producing cells. This process mimics the natural healing mechanisms of the body, promoting cellular tissue growth through a beneficial inflammatory response. In clinical practice, the most commonly utilized solution for prolotherapy is hypertonic dextrose, with concentrations ranging from 15% to 25%. Concentrations exceeding 10% are generally considered to induce local inflammation, thereby initiating a cascade of reparative effects.
Although numerous studies have investigated shoulder joint capsular distension procedures in the past, the injected solutions often comprised corticosteroids and saline. In clinical observations, the use of hypertonic dextrose injection combined with shoulder joint capsular distension appears to yield improved outcomes in terms of pain relief and joint angle progression in patients with adhesive capsulitis. However, there is currently no research investigating the effectiveness of hypertonic dextrose injection combined with shoulder joint capsular distension for treating frozen shoulder. This study aims to explore whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose | Experimental | Drug: Intra-articular corticosteroid injection, Drug: hydrodilation with 15% hypertonic dextroseThe patient receives ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection with 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml Normal saline, totaling 20 ml). The entire treatment comprises two sessions. |
| Intra-articular corticosteroid injection and hydrodilation with Normal saline | Placebo comparator | Drug: Intra-articular corticosteroid injection, Drug: hydrodilation with Normal salineThe patient receives ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection with 15% hypertonic dextrose ( 2 ml 2% Xylocaine + 18 ml Normal saline, totaling 20 ml). The entire treatment comprises two sessions. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The diagnosis of frozen shoulder is determined by physicians through an evaluation of the patient's medical history, physical examination, and assessment of X-ray and ultrasound reports.
- The duration of symptoms should be more than 3 months.
- There should be a decrease of at least 30 degrees in a minimum of two shoulder joint angles (shoulder flexion, abduction, and external rotation) compared to the corresponding angles on the healthy side.
Key exclusion criteria (8 listed)
- Ultrasound examination of the shoulder muscles must not reveal a complete tear or massive tear of the rotator cuff tendon or evidence of calcific tendinitis.
- Presence of systemic rheumatic disease.
- History of previous shoulder fracture or undergoing surgical intervention.
- Receipt of shoulder joint injections within the last 3 months.
- Acute cervical nerve root compression.
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 |
|---|---|---|
| Intra-articular corticosteroid injectionUltrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine) is performed once for the patient at the first week. | Drug | Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose, Intra-articular corticosteroid injection and hydrodilation with Normal saline |
| hydrodilation with 15% hypertonic dextroseThe second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml normal saline, totaling 20 ml). | Drug | Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose |
| hydrodilation with Normal salineThe second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is Normal saline (2 ml 2% Xylocaine + 18 ml normal saline, totaling 20 ml). | Drug | Intra-articular corticosteroid injection and hydrodilation with Normal saline |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
2 secondary outcomes
Range of Motion (ROM)
Time frame: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
Shoulder Pain and Disability Index (SPADI)
Time frame: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular corticosteroid injection, hydrodilation with 15% hypertonic dextrose and hydrodilation with Normal saline in people with Frozen Shoulder, run by Tri-Service General Hospital (TSGH).
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 3 inclusion and 8 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Chih-Ya Chang, MD (886-2-87923311 ext. 13707, gradesboy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months). 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 12 Dec 2023.