Frozen ShoulderNCT03515278
Effect of Ultrasound-guided Suprascapular Nerve Block Versus Intra-articular Corticosteroid Injection for Frozen Shoulder
A study testing SCNB group and IACI group in people with Frozen Shoulder, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators aim to compare the effect of ultrasound-guided suprascapular nerve block and intra-articular corticosteroid injection for frozen shoulder in pain control, improvement of range of motion, quality of life, and function. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- SCNB group and IACI group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Feb 2018to 31 Dec 2019
- 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
- unilateral side involvement.
- ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
- duration of symptoms ≥3 months.
- age≥ 20year old.
Who cannot join
- ever received manipulation of the affected shoulder with/without anesthesia.
- systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
- neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
- pain or disorders of the cervical spine, elbow, wrist, or hand.
- a history of drug allergy to local or corticosteroids.
- Pregnancy or lactation.
- Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Suprascapular Nerve Block Versus Intra-articular Corticosteroid Injection for Frozen Shoulder: a Randomized Control Trial
The investigators aim to compare the effect of ultrasound-guided suprascapular nerve block and intra-articular corticosteroid injection for frozen shoulder in pain control, improvement of range of motion, quality of life, and function.
Read the detailed description
The inclusion criteria is: 1. unilateral side involvement; 2. ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side; 3. duration of symptoms ≥3 months. 4. age≥ 20year old.
The exclusion criteria include: 1. ever received manipulation of the affected shoulder with/without anesthesia; 2. systemic disease, severe degeneration, or trauma involving the shoulder (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.); 3. neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder; 4.pain or disorders of the cervical spine, elbow, wrist, or hand; 5.a history of drug allergy to local or corticosteroids; 6. Pregnancy or lactation; and 7. Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks 70 participants will be randomly divided to SCNB group and IACI group. Each subject in either group will receive 2 times of injection in a two-weekly interval. After injection, each subject in either group will receive the same protocol of physiotherapy program for 2 months. Outcome measures include the SPADI, the SDQ, active and passive ROM of the affected shoulder, and SF-36. Evaluation will be performed at baseline and at 4 weeks and 12 weeks after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations.
A Shapiro-Wilk test will be applied to ensure that all the calculated variables followed a normal distribution. Subsequently, a 2-by-3, 2-way mixed-model analysis of variance, which has 1 between-subject factor (group: SCNB and IACI) and 1 within-subject factor (evaluation time: pretreatment, 4 weeks after beginning treatment, and 12 weeks after the beginning of the treatment), will be performed. Pair-wise comparisons between groups will be performed using an independent t test when a significant interaction is found; otherwise, the main effects are reported. When a time effect is found, a post hoc analysis will be performed using a polynomial test to determine the trend (linear or quadratic). All significance levels are set at alpha=.05, and SPSS version 15.0a will be used for all the statistical analyses.
- Conditions
- Frozen Shoulder
- Being tested
- SCNB group, IACI group
- Keywords
- Frozen shoulder, adhesive capsulitis, ultrasound-guided intervention, suprascapular nerve block, intra-articular injection
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCNB groupProcedure or surgery
Also called IACI group
IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.
IACI groupProcedure or surgery
Also called SCNB group
SCNB is a new choice for treatment of frozen shoulder.As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to infiltrate the nerve accurately without injury to the nerves or vessels.
| Study group | Role | What they receive |
|---|---|---|
| suprascapular nerve block (SCNB) group | Experimental | SCNB with physiotherapy. Suprascapular nerve block: Ultrasound-guided SCNB by 3 c.c. 1% lidocaine with 20mg triamcinolone.
Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) Receives: Procedure: SCNB group |
| intra-articular corticosteroid injection (IACI) group | Active comparator | IACI with physiotherapy. Intra-articular steroid Injections: Receive intra-articular corticosteroid injection.Ultrasound-guided IACI with 3c.c. 1% lidocaine and 20mg triamcinolone.
Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) Receives: Procedure: IACI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of scores of the Shoulder Pain and Disability Index (SPADI)
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
Measured: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Secondary outcomes (3)
the active ROM
The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.
Measured: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of the Shoulder Disability Questionnaire (SDQ)
The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained 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 situation).
Measured: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of 36-item Short-Form Health Survey (SF-36)
The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).
Measured: baseline and at 4 weeks and 12 weeks 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 posted3 May 2018
- Study start13 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin-Fen Hsieh, M.D, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515278
- Sponsor's protocol ID
- 20170915R
- Other IDs
- 2018SKHADR029
- Status last verified
- Jan 2020
- First submitted
- 13 Apr 2018
- Last updated
- 23 Dec 2020
- 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 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Suprascapular Nerve Block Versus Intra-articular Corticosteroid Injection for Frozen Shoulder: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03515278
- Acronym / sponsor ID
- 20170915R
- Conditions
- Frozen Shoulder
- Keywords
- Frozen shoulder, adhesive capsulitis, ultrasound-guided intervention, suprascapular nerve block, intra-articular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 May 2018 (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 investigators aim to compare the effect of ultrasound-guided suprascapular nerve block and intra-articular corticosteroid injection for frozen shoulder in pain control, improvement of range of motion, quality of life, and function.
Detailed description
The inclusion criteria is: 1. unilateral side involvement; 2. ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side; 3. duration of symptoms ≥3 months. 4. age≥ 20year old.
The exclusion criteria include: 1. ever received manipulation of the affected shoulder with/without anesthesia; 2. systemic disease, severe degeneration, or trauma involving the shoulder (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.); 3. neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder; 4.pain or disorders of the cervical spine, elbow, wrist, or hand; 5.a history of drug allergy to local or corticosteroids; 6. Pregnancy or lactation; and 7. Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks 70 participants will be randomly divided to SCNB group and IACI group. Each subject in either group will receive 2 times of injection in a two-weekly interval. After injection, each subject in either group will receive the same protocol of physiotherapy program for 2 months. Outcome measures include the SPADI, the SDQ, active and passive ROM of the affected shoulder, and SF-36. Evaluation will be performed at baseline and at 4 weeks and 12 weeks after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations.
A Shapiro-Wilk test will be applied to ensure that all the calculated variables followed a normal distribution. Subsequently, a 2-by-3, 2-way mixed-model analysis of variance, which has 1 between-subject factor (group: SCNB and IACI) and 1 within-subject factor (evaluation time: pretreatment, 4 weeks after beginning treatment, and 12 weeks after the beginning of the treatment), will be performed. Pair-wise comparisons between groups will be performed using an independent t test when a significant interaction is found; otherwise, the main effects are reported. When a time effect is found, a post hoc analysis will be performed using a polynomial test to determine the trend (linear or quadratic). All significance levels are set at alpha=.05, and SPSS version 15.0a will be used for all the statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suprascapular nerve block (SCNB) group | Experimental | Procedure: SCNB groupSCNB with physiotherapy. Suprascapular nerve block: Ultrasound-guided SCNB by 3 c.c. 1% lidocaine with 20mg triamcinolone. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) |
| intra-articular corticosteroid injection (IACI) group | Active comparator | Procedure: IACI groupIACI with physiotherapy. Intra-articular steroid Injections: Receive intra-articular corticosteroid injection.Ultrasound-guided IACI with 3c.c. 1% lidocaine and 20mg triamcinolone. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral side involvement.
- ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
- duration of symptoms ≥3 months.
- age≥ 20year old.
Key exclusion criteria (7 listed)
- ever received manipulation of the affected shoulder with/without anesthesia.
- systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
- neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
- pain or disorders of the cervical spine, elbow, wrist, or hand.
- a history of drug allergy to local 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 |
|---|---|---|
| SCNB groupAlso: IACI groupIACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy. | Procedure or surgery | suprascapular nerve block (SCNB) group |
| IACI groupAlso: SCNB groupSCNB is a new choice for treatment of frozen shoulder.As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to infiltrate the nerve accurately without injury to the nerves or vessels. | Procedure or surgery | intra-articular corticosteroid injection (IACI) group |
Primary outcome
Change of scores of the Shoulder Pain and Disability Index (SPADI)
Time frame: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
3 secondary outcomes
the active ROM
Time frame: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of the Shoulder Disability Questionnaire (SDQ)
Time frame: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of 36-item Short-Form Health Survey (SF-36)
Time frame: baseline and at 4 weeks and 12 weeks 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 23 Dec 2020.
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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, M.D 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 SCNB group and IACI group in people with Frozen Shoulder, 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 7 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 23 Dec 2020. 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?
Change of scores of the Shoulder Pain and Disability Index (SPADI) (time frame: baseline and at 4 weeks and 12 weeks 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 23 Dec 2020.