HemiplegiaNCT04433377
Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain
A study testing Suprascapular nerve block and Subacromial injection in people with Hemiplegia and Pain, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder pain reduces range of motion (ROM) and hand function, resulting in limited daily life activity and decreased quality of life. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hemiplegia, Pain
- What is being tested?
- Suprascapular nerve block and Subacromial injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2020to 1 Oct 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brunstrom stage 2 to 5
- spasticity <4 according to the modified Ashworth scale
- having hemiplegia less than 12 months
- Presence of shoulder pain lasting more than 3 months
- Conservative treatment for painful shoulder before injection
Who cannot join
- Patients over 75 years old, under 30 years old
- Anti-coagulant or antiaggregant use
- Presence of diabetes mellitus
- Patients who could not be cooperated and Mini-mental Test (MMSE) score <24
- Having previously had suprascapular block or subacromial injection
- Presence of complex regional pain syndrome (type I),
- The presence of neglect syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, Bahcelievler, 34180
About this study
Official title: Comparison of the Effects of Ultrasound-guided Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain: a Randomized Controlled Trial
Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder pain reduces range of motion (ROM) and hand function, resulting in limited daily life activity and decreased quality of life.
In the literature, the effectiveness of suprascapular nerve block and subacromial injection in hemiplegia patients with shoulder pain has been previously evaluated, but these injection treatments have not been compared.
Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia patients with shoulder pain.
Read the detailed description
Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block group
In the suprascapular nerve block group, suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.
In the subacromial injection group, subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.
A home exercise program will be given both groups. The exercise program consisted of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).
- Conditions
- Hemiplegia, Pain
- Being tested
- Suprascapular nerve block, Subacromial injection
- Medical subject headings
- Hemiplegia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve blockProcedure or surgery
A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector
Subacromial injectionProcedure or surgery
A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector.
| Study group | Role | What they receive |
|---|---|---|
| Suprascapular nerve block group | Experimental | Suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.
Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set). Receives: Procedure: Suprascapular nerve block |
| Subacromial injection group | Experimental | Subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.
Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set). Receives: Procedure: Subacromial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Visual Analog Scale (VAS) score
Self-reported neck pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt in the past week ("0" defines "no pain" and "10" defines "unbearable pain'').
Measured: baseline, month 1 and month 3
Secondary outcomes (3)
Shoulder ROM
The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.
Measured: baseline, month 1 and month 3
Functional Independence Measure (FIM)
Functional independence measure (FIM) will be used to evaluate independence for the activities of daily living. It was developed to measure the results of the rehabilitation on the patient. The higher scores in FIM are interpreted as better functional independence
Measured: baseline, month 1 and month 3
EuroQol 5D-3L questionnaire (EQ-5D-3L)
The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), will be used to evaluate the quality of life
Measured: baseline, month 1 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start28 May 2020
- Primary completion1 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Corum, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Mustafa Corum, MD, Principal investigator, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433377
- Sponsor's protocol ID
- 2020-118
- Status last verified
- Oct 2020
- First submitted
- 9 Jun 2020
- Last updated
- 19 Oct 2020
- Results posted
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-guided Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04433377
- Acronym / sponsor ID
- 2020-118
- Conditions
- Hemiplegia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 28 May 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 Jun 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.
Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder pain reduces range of motion (ROM) and hand function, resulting in limited daily life activity and decreased quality of life.
In the literature, the effectiveness of suprascapular nerve block and subacromial injection in hemiplegia patients with shoulder pain has been previously evaluated, but these injection treatments have not been compared.
Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia patients with shoulder pain.
Detailed description
Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block group
In the suprascapular nerve block group, suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.
In the subacromial injection group, subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.
A home exercise program will be given both groups. The exercise program consisted of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprascapular nerve block group | Experimental | Procedure: Suprascapular nerve blockSuprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector. Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set). |
| Subacromial injection group | Experimental | Procedure: Subacromial injectionSubacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector. Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Brunstrom stage 2 to 5
- spasticity <4 according to the modified Ashworth scale
- having hemiplegia less than 12 months
- Presence of shoulder pain lasting more than 3 months
- Conservative treatment for painful shoulder before injection
Key exclusion criteria (7 listed)
- Patients over 75 years old, under 30 years old
- Anti-coagulant or antiaggregant use
- Presence of diabetes mellitus
- Patients who could not be cooperated and Mini-mental Test (MMSE) score <24
- Having previously had suprascapular block or subacromial injection
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 |
|---|---|---|
| Suprascapular nerve blockA betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector | Procedure or surgery | Suprascapular nerve block group |
| Subacromial injectionA betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector. | Procedure or surgery | Subacromial injection group |
Primary outcome
Change from Baseline in Visual Analog Scale (VAS) score
Time frame: baseline, month 1 and month 3
Self-reported neck pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt in the past week ("0" defines "no pain" and "10" defines "unbearable pain'').
3 secondary outcomes
Shoulder ROM
Time frame: baseline, month 1 and month 3
Functional Independence Measure (FIM)
Time frame: baseline, month 1 and month 3
EuroQol 5D-3L questionnaire (EQ-5D-3L)
Time frame: baseline, month 1 and month 3
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 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Mustafa Corum, MD principal investigator
Istanbul Physical Medicine Rehabilitation Training & Research 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 Suprascapular nerve block and Subacromial injection in people with Hemiplegia and Pain, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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 19 Oct 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 Turkey (Türkiye). 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 from Baseline in Visual Analog Scale (VAS) score (time frame: baseline, month 1 and month 3). 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 19 Oct 2020.