Shoulder ImpingementPhase 4NCT05015322

Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome

A Phase 4 study testing bupivacaine and methylprednisolone in people with Shoulder Impingement and Ultrasound Guided Injection, run by Bursa Yuksek Ihtisas Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Shoulder Impingement, Ultrasound Guided Injection
What is being tested?: bupivacaine and methylprednisolone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: No sites listed yet
Study dates: 1 Jan 2017to 1 Jan 2021
Phase: Phase 4
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients aged 18-65,
who were suffering from shoulder pain for more than three months and
who were diagnosed with IS.
All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.

Who cannot join

the presence of cervical radiculopathy;
undergoing shoulder operation before;
the presence of central nervous system or
the presence of rheumatological disease, and polyneuropathy;
receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and
receiving any injection therapy in the past.

About this study

Official title: Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial

Shoulder pain, which is the third most common cause of musculoskeletal pain, has different etiologies. Muscle, bone structures and connective tissue pathologies can cause shoulder pain. Impingement syndrome (IS), which can cover many terms such as rotator cuff disorders, tendinitis and tears, is one of the most common pathologies of shoulder pain.

Read the detailed description

The hypothesis of this study was that injection types including ACJ would increase treatment efficacy.Therefore, this study investigated the six-month follow-up results of patients undergoing SA injection and SSNB and those receiving SA and ACJ injection.

Conditions: Shoulder Impingement, Ultrasound Guided Injection
Being tested: bupivacaine and methylprednisolone
Medical subject headings: Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bupivacaine and methylprednisoloneDrug
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
bupivacaine and methylprednisoloneDrug
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
bupivacaine and methylprednisoloneDrug
Also called suprascapular nerve block
suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone

Study groups in NCT05015322
Study group	Role	What they receive
subacromial injection	Active comparator	ultrasound (US)-guided subacromial injection Receives: Drug: bupivacaine and methylprednisolone
acromioclavicular joint and subacromial injection	Active comparator	ultrasound (US)-guided acromioclavicular joint and subacromial injection Receives: Drug: bupivacaine and methylprednisolone
suprascapular nerve block	Active comparator	ultrasound (US)-guided suprascapular nerve block Receives: Drug: bupivacaine and methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale (VAS)
for pain. 0: no pain at all, 10: worst pain imaginable
Measured: six month

Secondary outcomes (2)

Shoulder pain and disability index (SPADI)
This scale was developed to measure pain and disability associated with shoulder pain. It consists of two parts evaluating pain and disability.
Measured: six month
Short-Form 12 (SF-12)
The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale
Measured: six month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20171 Jan 2021

First posted20 Aug 2021
Study start1 Jan 2017
Primary completion1 Jan 2021
Study completion1 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shoulder ImpingementStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: prospective,randomized controlled, single blind
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05015322
Sponsor's protocol ID: BYIEAH2
Status last verified: Aug 2021
First submitted: 18 Aug 2021
Last updated: 20 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome

All Shoulder Impingement trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial
ClinicalTrials.gov ID: NCT05015322
Acronym / sponsor ID: BYIEAH2
Conditions: Shoulder Impingement, Ultrasound Guided Injection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Bursa Yuksek Ihtisas Training and Research HospitalOther government
Study start: 1 Jan 2017 (actual)
Primary completion: 1 Jan 2021 (actual)
Study completion: 1 Jan 2021 (actual)
First posted: 20 Aug 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: prospective,randomized controlled, single blind

Arm	Type	Receives
subacromial injection	Active comparator	Drug: bupivacaine and methylprednisoloneultrasound (US)-guided subacromial injection
acromioclavicular joint and subacromial injection	Active comparator	Drug: bupivacaine and methylprednisoloneultrasound (US)-guided acromioclavicular joint and subacromial injection
suprascapular nerve block	Active comparator	Drug: bupivacaine and methylprednisoloneultrasound (US)-guided suprascapular nerve block

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

patients aged 18-65,
who were suffering from shoulder pain for more than three months and
who were diagnosed with IS.
All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.

Key exclusion criteria (6 listed)

the presence of cervical radiculopathy;
undergoing shoulder operation before;
the presence of central nervous system or
the presence of rheumatological disease, and polyneuropathy;
receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and

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
bupivacaine and methylprednisolone5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area	Drug	subacromial injection
bupivacaine and methylprednisolone5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint	Drug	acromioclavicular joint and subacromial injection
bupivacaine and methylprednisoloneAlso: suprascapular nerve blocksuprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone	Drug	suprascapular nerve block

Primary outcome

Visual Analogue Scale (VAS)
Time frame: six month
for pain. 0: no pain at all, 10: worst pain imaginable

2 secondary outcomes

Shoulder pain and disability index (SPADI)
Time frame: six month
Short-Form 12 (SF-12)
Time frame: six month

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 20 Aug 2021.

Related trials for Shoulder Impingement

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome

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.

Burcu Metin Ökmen, Assoc. Prof principal investigator

University of Health Sciences, Yuksek Ihtisas Training and Research Hospital

Korgün M Ökmen, Assoc. Prof study chair

Bursa Yuksek Ihtisas Training and Research Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing bupivacaine and methylprednisolone in people with Shoulder Impingement and Ultrasound Guided Injection, run by Bursa Yuksek Ihtisas Training and Research Hospital.

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 20 Aug 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visual Analogue Scale (VAS) (time frame: six month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05015322.

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 20 Aug 2021.