Suprascapular Nerve Block2015/8/1NCT02776865
Does Ultrasound-guided Suprascapular Nerve Block Provide Additional Benefit Over Traditional Rehabilitation Program for Patients With Chronic Shoulder Pain
A study testing suprascapular nerve block and physical therapy in people with Suprascapular Nerve Block, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Suprascapular Nerve Block
- What is being tested?
- suprascapular nerve block and physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2015to Oct 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic shoulder pain with duration of complaints more than 3 months
- diagnosis of frozen shoulder or rotator cuff disorder
Who cannot join
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to xylocaine
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
Trial locations and contacts
1 site in 1 country.
Jia chi Wang, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei veteran general hospital
Taipei
Jia chi Wang
About this study
Official title: Does Ultrasound-guided Suprascapular Nerve Block Provide Additional Benefit
This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis
- Conditions
- Suprascapular Nerve Block
- Being tested
- suprascapular nerve block, physical therapy
- Keywords
- suprascapular nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprascapular nerve blockDrug
Also called 4cc 2% xylocaine
4ml 2% xylocaine
physical therapyOther
Also called rehabilitation
patient received traditional physical therapy, including therapeutic exercise and stretch exercise
| Study group | Role | What they receive |
|---|---|---|
| physical therapy and suprascapular nerve block | Experimental | patient received ultrasound-guided suprascapular nerve block as well as physical therapy. Receives: Drug: suprascapular nerve block; Other: physical therapy |
| physical therapy only | Active comparator | patient received physical therapy only. Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in constant shoulder score
the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Measured: at 4, 12 wk
Secondary outcomes (3)
change in pain intensity
pain intensity was measured by visual analog scale.
Measured: at 4, 12 wk
change in Shoulder Pain And disability index
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Measured: at 6, 12 wk
change in glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
Measured: at 4, 12 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suprascapular Nerve BlockStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776865
- Sponsor's protocol ID
- 2015-09-009C
- Acronym
- 2015/8/1
- Status last verified
- Mar 2016
- First submitted
- 16 May 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasound-guided Suprascapular Nerve Block Provide Additional Benefit
- ClinicalTrials.gov ID
- NCT02776865
- Acronym / sponsor ID
- 2015/8/1 / 2015-09-009C
- Conditions
- Suprascapular Nerve Block
- Keywords
- suprascapular nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- First posted
- 18 May 2016 (estimated)
- 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 was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy and suprascapular nerve block | Experimental | Drug: suprascapular nerve block, Other: physical therapypatient received ultrasound-guided suprascapular nerve block as well as physical therapy. |
| physical therapy only | Active comparator | Other: physical therapypatient received physical therapy only. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic shoulder pain with duration of complaints more than 3 months
- diagnosis of frozen shoulder or rotator cuff disorder
Key exclusion criteria (6 listed)
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to xylocaine
- pregnancy or lactation;
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 blockAlso: 4cc 2% xylocaine4ml 2% xylocaine | Drug | physical therapy and suprascapular nerve block |
| physical therapyAlso: rehabilitationpatient received traditional physical therapy, including therapeutic exercise and stretch exercise | Other | physical therapy and suprascapular nerve block, physical therapy only |
Primary outcome
change in constant shoulder score
Time frame: at 4, 12 wk
the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
3 secondary outcomes
change in pain intensity
Time frame: at 4, 12 wk
change in Shoulder Pain And disability index
Time frame: at 6, 12 wk
change in glenohumeral joint range of motion
Time frame: at 4, 12 wk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
Jia chi Wang, MD contact
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 physical therapy in people with Suprascapular Nerve Block, run by Taipei Veterans General Hospital, Taiwan 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 2 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: status not confirmed, as of the sponsor's last update on 18 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia chi Wang, MD (jcwang0726@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in constant shoulder score (time frame: at 4, 12 wk). 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 18 May 2016.