Frozen ShoulderNCT04474145
The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
A study testing Comb group and PT group in people with Frozen Shoulder and Hydrodilatation, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
The effect of combination of hydrodilatation, corticosteroid injection, and joint mobilization for treatment of frozen shoulder, compared with general physical therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Frozen Shoulder, Hydrodilatation, Joint Mobilization
- What is being tested?
- Comb group and PT group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . age between 20 to 80 years old;
- . chronic shoulder pain for ≥ 3 months;
- . > 30% loss of passive range of motion (ROM) of the affected shoulder in either external rotation or abduction, comparing with the sound side;
- . visual analog scale for pain on maximal passive external rotation or abduction > 4.
Who cannot join
- . Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
- . Uncontrolled DM;
- . Rotator cuff tear or calcification of the affected shoulder;
- . Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
- . a history of drug allergy to local anesthetics or corticosteroids;
- . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.
Trial locations and contacts
1 site in 1 country.
About this study
The effect of combination of hydrodilatation, corticosteroid injection, and joint mobilization for treatment of frozen shoulder, compared with general physical therapy.
Read the detailed description
Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and active range of motion (ROM) of glenohumeral joint, and leads to disability, functional limitation, and decreasing quality of life. FS is usually treated with conservative treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation, intra-articular steroid injection, etc.. The short-term effect of each treatment is variable, and the long-term effect is not established. Clinically combination of each treatment is common, but types of combination, and the effect of combination is still not well studied. We aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and general physiotherapy to treat frozen shoulder and compare the long-term effect with general physical therapy alone.
This is a prospective single-blind randomized controlled trial. 70 participants will be recruited from the outpatient clinic of the department of Physical Medicine and Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline) through both anterior and posterior shoulder joint in a two-weekly interval. In addition, joint mobilization and general physiotherapy (stretch exercise and physical modalities) will also be given, 2 times a week, for 8 weeks. The PT group will receive general physical therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36), and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations. We expect that the COMB group will recover sooner and better than the PT group.
- Conditions
- Frozen Shoulder, Hydrodilatation, Joint Mobilization, Corticosteroid Injection, Physical Therapy, Rehabilitation
- Being tested
- Comb group, PT group
- Keywords
- frozen shoulder, hydrodilatation, joint mobilization, corticosteroid injection, physical therapy, rehabilitation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comb groupProcedure or surgery
Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.
PT groupProcedure or surgery
The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Comb group | Active comparator | Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection. Receives: Procedure: Comb group |
| PT group | Active comparator | The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle. Receives: Procedure: PT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index（SPADI）
Measured: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary outcomes (4)
Visual analog scale（VAS）
The VAS for pain is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of VAS for pain is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
Measured: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Range of motion（ROM）
All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.
Measured: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Shoulder Disability Questionnaire（SDQ）
The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).
Measured: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
The 36-item Short Form Health Survey（SF-36）
The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.
Measured: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Aug 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Lin-Fen Hsieh, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474145
- Sponsor's protocol ID
- 20191212R
- Other IDs
- NSTC 109-2314-B-341-002, NSTC 110-2314-B-341-002
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
- ClinicalTrials.gov ID
- NCT04474145
- Acronym / sponsor ID
- 20191212R
- Conditions
- Frozen Shoulder, Hydrodilatation, Joint Mobilization, Corticosteroid Injection, Physical Therapy, Rehabilitation
- Keywords
- frozen shoulder, hydrodilatation, joint mobilization, corticosteroid injection, physical therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 16 Jul 2020 (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 effect of combination of hydrodilatation, corticosteroid injection, and joint mobilization for treatment of frozen shoulder, compared with general physical therapy.
Detailed description
Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and active range of motion (ROM) of glenohumeral joint, and leads to disability, functional limitation, and decreasing quality of life. FS is usually treated with conservative treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation, intra-articular steroid injection, etc.. The short-term effect of each treatment is variable, and the long-term effect is not established. Clinically combination of each treatment is common, but types of combination, and the effect of combination is still not well studied. We aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and general physiotherapy to treat frozen shoulder and compare the long-term effect with general physical therapy alone.
This is a prospective single-blind randomized controlled trial. 70 participants will be recruited from the outpatient clinic of the department of Physical Medicine and Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline) through both anterior and posterior shoulder joint in a two-weekly interval. In addition, joint mobilization and general physiotherapy (stretch exercise and physical modalities) will also be given, 2 times a week, for 8 weeks. The PT group will receive general physical therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36), and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations. We expect that the COMB group will recover sooner and better than the PT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comb group | Active comparator | Procedure: Comb groupPatients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks. The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection. |
| PT group | Active comparator | Procedure: PT groupThe physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . age between 20 to 80 years old;
- . chronic shoulder pain for ≥ 3 months;
- . > 30% loss of passive range of motion (ROM) of the affected shoulder in either external rotation or abduction, comparing with the sound side;
- . visual analog scale for pain on maximal passive external rotation or abduction > 4.
Key exclusion criteria (6 listed)
- . Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
- . Uncontrolled DM;
- . Rotator cuff tear or calcification of the affected shoulder;
- . Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
- . a history of drug allergy to local anesthetics or corticosteroids;
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 |
|---|---|---|
| Comb groupPatients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks. The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection. | Procedure or surgery | Comb group |
| PT groupThe physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle. | Procedure or surgery | PT group |
Primary outcome
Shoulder Pain and Disability Index（SPADI）
Time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
4 secondary outcomes
Visual analog scale（VAS）
Time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Range of motion（ROM）
Time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Shoulder Disability Questionnaire（SDQ）
Time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
The 36-item Short Form Health Survey（SF-36）
Time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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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.
Lin-Fen Hsieh principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comb group and PT group in people with Frozen Shoulder and Hydrodilatation, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index（SPADI） (time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.). 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 31 Oct 2022.