Frozen ShoulderNCT06165926
Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder
A study testing 15% hypertonic dextrose, Normal saline and physical therapy in people with Frozen Shoulder, run by Tri-Service General Hospital (TSGH).
Trial summary
The aim of our study is to investigate whether the combination of hypertonic dextrose injection and shoulder joint hydrodilation, in conjunction with physical therapy, can effectively enhance shoulder joint pain relief, improve range of motion, and enhance daily life functionality in patients with 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?
- 15% hypertonic dextrose, Normal saline and physical therapy
- 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
- Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
- The symptoms persist for more than 3 months.
- There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.
Who cannot join
- Ultrasound of the shoulder muscles reveals a complete tear or massive tear of the rotator cuff tendon or calcific tendinitis.
- Systemic rheumatic disease.
- Previous shoulder fracture or surgical intervention.
- Recent shoulder joint injections within the last 3 months.
- Acute cervical nerve root compression.
- Current pregnancy or breastfeeding.
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- Poorly controlled diabetes (intravenous glucose injection may cause temporary blood sugar elevation).
- Patients with cancer.
- Cognitive impairment, inability to follow simple instructions, or inability to cooperate with the study procedures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Intra-Articular Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder: A Randomized Controlled Trial
The aim of our study is to investigate whether the combination of hypertonic dextrose injection and shoulder joint hydrodilation, in conjunction with physical therapy, can effectively enhance shoulder joint pain relief, improve range of motion, and enhance daily life functionality in patients with frozen shoulder.
Read the detailed description
Frozen shoulder (FS), also known as adhesive capsulitis, is a common shoulder ailment, with an annual incidence of approximately 2.4 individuals per 100,000, accounting for about 2% of the total population. The onset of symptoms is predominant in individuals aged forty to sixty years, presenting as persistent restrictions in shoulder joint mobility accompanied by shoulder joint pain.
While the detailed mechanisms underlying 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 in individuals with frozen shoulder. Additionally, research suggests that in cases of severe inflammation, certain cytokines and growth factors drive fibroblasts to replace normal tissue through repair and remodeling responses. This excessive fibrosis and the loss of normal collagen remodeling response further contribute to the development of frozen shoulder.
The meta-analysis published in JAMA Network in 2020 highlighted the significance of medium to long-term physical therapy in facilitating subsequent improvements in range of motion and functionality for patients with adhesive capsulitis, also known as frozen shoulder. Moreover, numerous studies suggest that combining intra-articular injections with shoulder joint capsular distension procedures, such as hydrodilatation, can enhance shoulder joint function and mobility.
Prolotherapy is a non-surgical regenerative injection therapy involving the injection of 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 the hypertonic dextrose with concentrations ranging from 15% to 25%. Concentrations exceeding 10% are generally considered to induce local inflammation, thereby triggering a cascade of reparative effects.
Although there have been numerous studies on shoulder joint capsular distension procedures in the past, the injected solutions often consisted of corticosteroids and saline. In clinical observations, the use of hypertonic dextrose injection combined with shoulder joint capsular distension appears to offer 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. Therefore, this study represents the first exploration of whether the use of hypertonic dextrose injection combined with shoulder joint hydrodilatation and physical therapy is more effective than the conventional approach using saline injection combined with physical therapy in the treatment of frozen shoulder.
- Conditions
- Frozen Shoulder
- Being tested
- 15% hypertonic dextrose, Normal saline, physical therapy
- Keywords
- Frozen Shoulder, hypertonic dextrose injection, hydrodilation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% hypertonic dextroseDrug
The solution is prepared with 3 ml of 50% Dextrose, 1 ml of 2% xylocaine, and 6 ml of normal saline.
The ultrasound-guided injection of 15% hypertonic dextrose is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with hypertonic dextrose is performed at the fourth weeks. A total of 2 sessions of hypertonic dextrose injections are performed.
Normal salineDrug
The solution is prepared with 1 ml of 2% xylocaine + 9 ml of normal saline. The ultrasound-guided injection of Normal saline(0.9%) is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with Normal saline is performed at the fourth weeks. A total of 2 sessions of Normal saline injections are performed.
physical therapyOther
Under the guidance and supervision of a physical therapist, the patient undergoes physical therapy sessions twice a week for a total duration of 8 weeks. Each session lasts approximately 30 minutes and includes joint activities, stretching, and muscle-strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| 15% hypertonic dextrose and physical therapy | Experimental | The patient receives a single ultrasound-guided injection of 15% hypertonic dextrose into the shoulder joint (3 ml of 50% Dextrose + 1 ml of 2% xylocaine + 6 ml of normal saline). Subsequent evaluations occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection treatment, totally two sessions. Simultaneously, the patient undergoes an 8-week physical therapy program, attending sessions twice a week. Each session, lasting approximately 30 minutes, includes joint activities, stretching, and muscle-strengthening exercises under the guidance and supervision of a physical therapist. Receives: Drug: 15% hypertonic dextrose; Other: physical therapy |
| normal saline and physical therapy | Placebo comparator | The patient undergoes a single ultrasound-guided normal saline injection for shoulder joint distension (1 ml of 2% xylocaine + 9 ml of normal saline). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection treatment, totally two sessions. Simultaneously, the patient is undergoing an 8-week physical therapy program, with sessions held twice a week. Each session, lasting approximately 30 minutes, includes joint activities, stretching, and muscle-strengthening exercises under the guidance and supervision of a physical therapist. Receives: Drug: Normal saline; Other: physical therapy |
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
- NCT06165926
- Sponsor's protocol ID
- A202305063
- 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
- Efficacy of Intra-Articular Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06165926
- Acronym / sponsor ID
- A202305063
- Conditions
- Frozen Shoulder
- Keywords
- Frozen Shoulder, hypertonic dextrose injection, hydrodilation
- 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.
The aim of our study is to investigate whether the combination of hypertonic dextrose injection and shoulder joint hydrodilation, in conjunction with physical therapy, can effectively enhance shoulder joint pain relief, improve range of motion, and enhance daily life functionality in patients with frozen shoulder.
Detailed description
Frozen shoulder (FS), also known as adhesive capsulitis, is a common shoulder ailment, with an annual incidence of approximately 2.4 individuals per 100,000, accounting for about 2% of the total population. The onset of symptoms is predominant in individuals aged forty to sixty years, presenting as persistent restrictions in shoulder joint mobility accompanied by shoulder joint pain.
While the detailed mechanisms underlying 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 in individuals with frozen shoulder. Additionally, research suggests that in cases of severe inflammation, certain cytokines and growth factors drive fibroblasts to replace normal tissue through repair and remodeling responses. This excessive fibrosis and the loss of normal collagen remodeling response further contribute to the development of frozen shoulder.
The meta-analysis published in JAMA Network in 2020 highlighted the significance of medium to long-term physical therapy in facilitating subsequent improvements in range of motion and functionality for patients with adhesive capsulitis, also known as frozen shoulder. Moreover, numerous studies suggest that combining intra-articular injections with shoulder joint capsular distension procedures, such as hydrodilatation, can enhance shoulder joint function and mobility.
Prolotherapy is a non-surgical regenerative injection therapy involving the injection of 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 the hypertonic dextrose with concentrations ranging from 15% to 25%. Concentrations exceeding 10% are generally considered to induce local inflammation, thereby triggering a cascade of reparative effects.
Although there have been numerous studies on shoulder joint capsular distension procedures in the past, the injected solutions often consisted of corticosteroids and saline. In clinical observations, the use of hypertonic dextrose injection combined with shoulder joint capsular distension appears to offer 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. Therefore, this study represents the first exploration of whether the use of hypertonic dextrose injection combined with shoulder joint hydrodilatation and physical therapy is more effective than the conventional approach using saline injection combined with physical therapy in the treatment of 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 |
|---|---|---|
| 15% hypertonic dextrose and physical therapy | Experimental | Drug: 15% hypertonic dextrose, Other: physical therapyThe patient receives a single ultrasound-guided injection of 15% hypertonic dextrose into the shoulder joint (3 ml of 50% Dextrose + 1 ml of 2% xylocaine + 6 ml of normal saline). Subsequent evaluations occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection treatment, totally two sessions. Simultaneously, the patient undergoes an 8-week physical therapy program, attending sessions twice a week. Each session, lasting approximately 30 minutes, includes joint activities, stretching, and muscle-strengthening exercises under the guidance and supervision of a physical therapist. |
| normal saline and physical therapy | Placebo comparator | Drug: Normal saline, Other: physical therapyThe patient undergoes a single ultrasound-guided normal saline injection for shoulder joint distension (1 ml of 2% xylocaine + 9 ml of normal saline). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection treatment, totally two sessions. Simultaneously, the patient is undergoing an 8-week physical therapy program, with sessions held twice a week. Each session, lasting approximately 30 minutes, includes joint activities, stretching, and muscle-strengthening exercises under the guidance and supervision of a physical therapist. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
- The symptoms persist for more than 3 months.
- There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.
Key exclusion criteria (9 listed)
- Ultrasound of the shoulder muscles reveals a complete tear or massive tear of the rotator cuff tendon or calcific tendinitis.
- Systemic rheumatic disease.
- Previous shoulder fracture or surgical intervention.
- Recent 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 |
|---|---|---|
| 15% hypertonic dextroseThe solution is prepared with 3 ml of 50% Dextrose, 1 ml of 2% xylocaine, and 6 ml of normal saline. The ultrasound-guided injection of 15% hypertonic dextrose is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with hypertonic dextrose is performed at the fourth weeks. A total of 2 sessions of hypertonic dextrose injections are performed. | Drug | 15% hypertonic dextrose and physical therapy |
| Normal salineThe solution is prepared with 1 ml of 2% xylocaine + 9 ml of normal saline. The ultrasound-guided injection of Normal saline(0.9%) is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with Normal saline is performed at the fourth weeks. A total of 2 sessions of Normal saline injections are performed. | Drug | normal saline and physical therapy |
| physical therapyUnder the guidance and supervision of a physical therapist, the patient undergoes physical therapy sessions twice a week for a total duration of 8 weeks. Each session lasts approximately 30 minutes and includes joint activities, stretching, and muscle-strengthening exercises. | Other | 15% hypertonic dextrose and physical therapy, normal saline and physical therapy |
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 15% hypertonic dextrose, Normal saline and physical therapy 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 9 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.